You are on page 1of 92

SAFETY DATA SHEET

according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 1(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

SECTION 1: Identification of the substance/mixture and of the company/undertaking

1.1. Product identifier


Trade name
PRAEPAGEN HY
Material number: 107829
Chemical nature: Quaternary ammonium compounds, C12-14-(even
numbered)alkyl(hydroxyethyl)dimethyl, chlorides - EC no. 931-
275-3 (former CAS 85736-63-6)as aqueous solution (approx.
40%)

1.2. Relevant identified uses of the substance or mixture and uses advised against
Relevant identified uses of the substance or mixture
Industry sector : Industrial & Institutional Cleaning
Type of use : Raw material for detergents
Exposure scenarios: see annex

1.3. Details of the supplier of the safety data sheet


Identification of the company
Clariant Produkte (Deutschland) GmbH
65926 Frankfurt am Main
Telephone no. : +49 69 305 18000
Information about the substance/mixture
BU Industrial & Consumer Specialties
Product Stewardship
e-mail: SDS.Europe@clariant.com

1.4. Emergency telephone number


00800-5121 5121 (24 h)

SECTION 2: Hazards identification

2.1 Classification of the substance or mixture


Classification (REGULATION (EC) No 1272/2008)
Acute toxicity, Category 4 H302: Harmful if swallowed.

Skin corrosion, Category 1C H314: Causes severe skin burns and eye damage.

Serious eye damage, Category 1 H318: Causes serious eye damage.

Specific target organ toxicity - repeated H373: May cause damage to organs through
exposure, Category 2 prolonged or repeated exposure.

Acute aquatic toxicity, Category 1 H400: Very toxic to aquatic life.

Chronic aquatic toxicity, Category 2 H411: Toxic to aquatic life with long lasting effects.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 2(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

2.2 Label elements


Labelling (REGULATION (EC) No 1272/2008)
Hazard pictograms :

Signal word : Danger

Hazard statements : H302 Harmful if swallowed.


H314 Causes severe skin burns and eye damage.
H373 May cause damage to organs through prolonged or
repeated exposure.
H410 Very toxic to aquatic life with long lasting effects.

Precautionary statements :
Prevention:
P260 Do not breathe dust/ fume/ gas/ mist/ vapours/ spray.
P264 Wash skin thoroughly after handling.
P273 Avoid release to the environment.
Response:
P314 Get medical advice/ attention if you feel unwell.
P391 Collect spillage.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.

Hazardous components which must be listed on the label:


N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride

2.3 Other hazards


Taking into account all available toxicty and ecotoxicity data, it can be concluded that the
ingredients of the mixture described here do not fulfil the criteria to be classified as either PBT or
vPvB.
This substance/mixture contains no components considered to be either persistent,
bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of
0.1% or higher.
No additional hazards are known except those derived from the labelling.

SECTION 3: Composition/information on ingredients

3.2 Mixtures
Hazardous components
Chemical name CAS-No. Classification Concentration
EC-No. (% w/w)
Registration number
N-(2-hydroxyethyl)-N,N-dimethyl Not Assigned Acute Tox. 4; H302 >= 30 - < 50
alkyl-C12-14-(even numbered)-1- Skin Corr. 1C; H314
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 3(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

aminium chloride 01-2119484688-17- STOT RE 2; H373


0000 Aquatic Acute 1;
01-2119484688-17- H400
0001 Aquatic Chronic 2;
H411
For explanation of abbreviations see section 16.

SECTION 4: First aid measures

4.1 Description of first aid measures


General advice : Remove/Take off immediately all contaminated clothing.
Show this safety data sheet to the doctor in attendance.

In case of skin contact : In case of contact, immediately flush skin with soap and plenty
of water.

In case of eye contact : In the case of contact with eyes, rinse immediately with plenty
of water and seek medical advice.

If swallowed : If swallowed, seek medical advice immediately and show this


container or label.

4.2 Most important symptoms and effects, both acute and delayed
Symptoms : No symptoms known currently.

Risks : No hazards known at this time.

4.3 Indication of any immediate medical attention and special treatment needed
Treatment : Treat symptomatically.

SECTION 5: Firefighting measures

5.1 Extinguishing media


Suitable extinguishing media : Water spray jet
Foam
Carbon dioxide (CO2)
Dry powder

5.2 Special hazards arising from the substance or mixture


Specific hazards during : In case of fires, hazardous combustion gases are formed:
firefighting Carbon monoxide (CO)
Nitrogen oxides (NOx)
Hydrogen chloride
Combustion gases of organic materials must in principle be
graded as inhalation poisons.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 4(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

5.3 Advice for firefighters


Special protective equipment : Self-contained breathing apparatus
for firefighters

SECTION 6: Accidental release measures

6.1 Personal precautions, protective equipment and emergency procedures


Personal precautions : Wear suitable protective clothing.

6.2 Environmental precautions


Environmental precautions : Do not empty into drains.

6.3 Methods and material for containment and cleaning up


Methods for cleaning up : Soak up with inert absorbent material (e.g. sand, silica gel,
acid binder, universal binder, sawdust).
Can be landfilled or incinerated, when in compliance with local
regulations.

6.4 Reference to other sections


Information regarding Safe handling, see chapter 7., For personal protection see section 8., For
disposal considerations see section 13.

SECTION 7: Handling and storage

7.1 Precautions for safe handling


Advice on safe handling : Handle and open container with care.

Advice on protection against : Observe the general rules of industrial fire protection
fire and explosion

Hygiene measures : Keep away from food and drink. Clean skin thoroughly after
work; apply skin cream.

7.2 Conditions for safe storage, including any incompatibilities


Further information on : - sensitive to frost - In case of the product becoming opaque,
storage conditions thickening or being frozen due to the effects of cold, allow to
thaw slowly at room temperature. Stir briefly before use.

7.3 Specific end use(s)


Specific use(s) : No further recommendations.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 5(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

SECTION 8: Exposure controls/personal protection

8.1 Control parameters


Derived No Effect Level (DNEL) according to Regulation (EC) No. 1907/2006:
Substance name End Use Exposure routes Potential health Value
effects
N-(2-hydroxyethyl)- Workers Dermal Long-term systemic 1,25 mg/kg
N,N-dimethyl alkyl- effects bw/day
C12-14-(even
numbered)-1-aminium
chloride
Remarks: DNEL
Workers Inhalation Long-term systemic 2,2 mg/m3
effects
Remarks: DNEL
General Dermal Long-term systemic 0,9 mg/kg
population effects bw/day
Remarks: DNEL
General Inhalation Long-term systemic 3,1 mg/m3
population effects
Remarks: DNEL
General Oral Long-term systemic 0,9 mg/kg
population effects
Remarks: DNEL
General Dermal Long-term local 0,02 % in
population effects mixture (by
weight)
Remarks: DNEL
Workers Dermal Long-term systemic 1,25 mg/kg
effects bw/day
Remarks: DNEL
Workers Inhalation Long-term systemic 2,2 mg/m3
effects
Remarks: DNEL
General Dermal Long-term systemic 0,9 mg/kg
population effects bw/day
Remarks: DNEL
General Inhalation Long-term systemic 3,1 mg/m3
population effects
Remarks: DNEL
General Oral Long-term systemic 0,9 mg/kg
population effects
Remarks: DNEL
General Dermal Long-term local 0,02 % in
population effects mixture (by
weight)
Remarks: DNEL
Predicted No Effect Concentration (PNEC) according to Regulation (EC) No. 1907/2006:
Substance name Environmental Compartment Value
N-(2-hydroxyethyl)-N,N-dimethyl Soil 0,61 mg/kg dry
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 6(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

alkyl-C12-14-(even numbered)-1- weight (d.w.)


aminium chloride
Sewage treatment plant 190 µg/l
Oral 16,7 mg/kg food
Fresh water 4 µg/l
salt water 0,4 µg/l
Water (intermittent release) 1,4 µg/l
Fresh water sediment 4,8 mg/kg dry
weight (d.w.)
Marine sediment 0,48 mg/kg dry
weight (d.w.)
Soil 0,61 mg/kg dry
weight (d.w.)
Sewage treatment plant 190 µg/l
Oral 16,7 mg/kg food
Fresh water 4 µg/l
salt water 0,4 µg/l
Water (intermittent release) 1,4 µg/l
Fresh water sediment 4,8 mg/kg dry
weight (d.w.)
Marine sediment 0,48 mg/kg dry
weight (d.w.)
8.2 Exposure controls
Personal protective equipment
Eye protection : Depending on the risk, wear sufficient eye protection (safety
glasses with side protection or goggles, and if necessary, face
shield.)

Hand protection
Remarks : These types of protective gloves are offered by various
manufacturers. Please note the manufacturers´ detailed
statements, especially about the minimum thickness and the
minimum breakthrough time. Consider also the particular
working conditions under which the gloves are being used.

Break through time : 30 min


Glove thickness : 0,4 mm
Remarks : For short-term exposure (splash protection): Nitrile rubber
gloves.

Break through time : 480 min


Glove thickness : 0,7 mm
Remarks : Long-term exposure Impervious butyl rubber gloves

Skin and body protection : Depending on the degree of hazard, when handling corrosive
substances, aprons, boots or full protective clothing made of
suitable materials (e.g. rubberized or PVC-coated) must also
be worn.
For details, see the BG-Information number 595.

Protective measures : Avoid contact with skin and eyes.


SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 7(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

SECTION 9: Physical and chemical properties

9.1 Information on basic physical and chemical properties


Appearance : Liquid

Colour : light yellow

Odour : characteristic

Odour Threshold : not tested.

pH : 5,5 - 8,5 (20 °C)


Concentration: 10 g/l

pour point : 0 °C
Method: ISO 3016

Boiling point : not determined

Flash point : > 100 °C


Method: DIN/ISO 2592 (open cup)

Evaporation rate : not tested.

Upper explosion limit : Not applicable

Lower explosion limit : Not applicable

Combustion number : Not applicable

Vapour pressure : approx. 23 hPa (20 °C)


Corresp. to vapour pressure of water

Relative vapour density : not tested.

Density : 0,9837 g/cm3 (20 °C)


Method: DIN EN ISO 12185

0,9740 g/cm3 (40 °C)


Method: DIN EN ISO 12185

0,9626 g/cm3 (60 °C)


Method: DIN EN ISO 12185

Bulk density : Not applicable

Solubility(ies)
Water solubility : soluble, Data corresponds to that of the active component

Solubility in other solvents : not tested.


Solvent: fat
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 8(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Partition coefficient: n- : log Pow: 2,3


octanol/water Information refers to the main component.

Auto-ignition temperature : Not applicable

Decomposition temperature : approx. 247 °C


Method: Thermogravimetry
The substance or mixture is not classified self-reactive.

Viscosity
Viscosity, dynamic : approx. 100 mPa.s (20 °C)

Viscosity, kinematic : not tested.

Explosive properties : Information refers to the main component.


There are no chemical groups associated with explosive
properties present in the molecule.

Oxidizing properties : Information refers to the main component.


There are no chemical groups associated with oxidising
properties present in the molecule.

9.2 Other information


Surface tension : 24,9 mN/m

Metal corrosion rate : The product shows corrosion properties to metals (Steel or
Aluminium), but not sufficient to classify it as corrosive. The
corrosion rate is < 6,25 mm/y at 55 ºC.

Minimum ignition energy : not tested.

Particle size : Not applicable

Self-ignition : Not applicable

SECTION 10: Stability and reactivity

10.1 Reactivity
See section 10.3. "Possibility of hazardous reactions"
10.2 Chemical stability
Stable
10.3 Possibility of hazardous reactions
Hazardous reactions : No dangerous reaction known under conditions of normal use.
Stable

10.4 Conditions to avoid


Conditions to avoid : Keep away from strong acids.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 9(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

10.5 Incompatible materials


Materials to avoid : not known

10.6 Hazardous decomposition products


Amine compounds

SECTION 11: Toxicological information

11.1 Information on toxicological effects


Acute toxicity
Product:
Acute oral toxicity : Acute toxicity estimate: 1.250 mg/kg
Method: Calculation method

Acute inhalation toxicity : Remarks: Study not performed as the substance is corrosive.

Acute dermal toxicity : Remarks: Study not performed as the substance is corrosive.

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Acute oral toxicity : LD50 (Rat, male and female): > 300 - 2.000 mg/kg , >200 <
2000 mg/kg
Method: OECD Test Guideline 401
GLP: yes

Acute inhalation toxicity : Remarks: Study not performed as the substance is corrosive.

Acute dermal toxicity : Remarks: Study not performed as the substance is corrosive.

Skin corrosion/irritation
Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Species: Rabbit
Exposure time: 4 h
Method: OECD Test Guideline 404
Result: Corrosive
GLP: yes

Serious eye damage/eye irritation


Product:
Remarks: Study not performed as the substance is corrosive.

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Remarks: Study not performed as the substance is corrosive.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 10(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Respiratory or skin sensitisation


Product:
Remarks: Study not performed as the substance is corrosive.

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Remarks: Study not performed as the substance is corrosive.
No sensitisation effects are known

Germ cell mutagenicity


Product:
Genotoxicity in vitro : Test Type: Ames test
Species: Salmonella typhimurium
Metabolic activation: with and without
Method: OECD Test Guideline 471
Result: Negative with and without metabolic activation
GLP: yes
Remarks: Test result obtained from the mixture.

: Test Type: Chromosome Aberration Test


Species: V79 cells (embryonic lung fibroblasts) of the Chinese
hamster
Metabolic activation: with and without
Method: OECD Test Guideline 473
Result: Negative with and without metabolic activation
GLP: yes
Remarks: Test result obtained from the mixture.

Germ cell mutagenicity- : It is concluded that the product is not mutagenic based on
Assessment evaluation of several mutagenicity tests.

Information refers to the main component.

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Genotoxicity in vitro : Test Type: Ames test
Species: Salmonella typhimurium
Concentration: 0,0016 - 1,6 µg/plate
Metabolic activation: with and without
Method: OECD Test Guideline 471
Result: negative
GLP: yes

: Test Type: Chromosome aberration test in vitro


Species: V79 cells (embryonic lung fibroblasts) of the Chinese
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 11(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

hamster
Concentration: 5 - 200 µg/ml
Metabolic activation: with and without
Method: OECD Test Guideline 473
Result: negative
GLP: yes

: Test Type: HGPRT assay


Species: V79 cells (embryonic lung fibroblasts) of the Chinese
hamster
Concentration: 2,5 - 230 µM
Metabolic activation: with and without
Method: OECD Test Guideline 476
Result: negative
GLP: yes

Germ cell mutagenicity- : It is concluded that the product is not mutagenic based on
Assessment evaluation of several mutagenicity tests.

Carcinogenicity
Product:
Carcinogenicity - : Contains no ingredient listed as a carcinogen
Assessment

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Remarks: From scientific point of view the study is not necessary.

Carcinogenicity - : Not applicable


Assessment

Reproductive toxicity
Product:
Reproductive toxicity - : No indications of toxic effects were observed in reproduction
Assessment studies in animals.

No reproductive toxicity to be expected.

Information refers to the main component.

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Effects on fertility : Test Type: Fertility

Remarks: The study is not necessary from a scientific


perspective.

Effects on foetal : Species: Rat, female


development Application Route: Oral
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 12(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Exposure time: Gestation days 6-19


Dose: 25 - 50 - 100 mg/kg
Group: yes
50 mg/kg
50 mg/kg
Number of exposures: Once daily
Method: OECD Test Guideline 414
GLP: yes

Reproductive toxicity - : No reproductive toxicity to be expected.


Assessment No teratogenic effects to be expected.

STOT - single exposure


Product:
Remarks: Based on available data, the classification criteria are not met.

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Remarks: Based on available data, the classification criteria are not met.

STOT - repeated exposure


Product:
Exposure routes: Oral
Target Organs: Gastrointestinal tract

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Assessment: May cause damage to organs through prolonged or repeated exposure.

Repeated dose toxicity


Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Species: Rat, male and female
NOAEL: 75 mg/kg
Application Route: oral (feed)
Exposure time: 90 d
Number of exposures: continuously
Dose: 15 - 50 - 75 mg/kg
Group: yes
Method: OPPTS 870.3100
GLP: yes

Aspiration toxicity
Product:
no data available
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 13(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
No aspiration toxicity classification

SECTION 12: Ecological information

12.1 Toxicity
Product:
Plant toxicity : NOEC: 12,3 mg/kg
End point: Growth
Test period: 21 d
Species: Avena sativa (oats)
Method: OECD Guide-line 208
GLP: yes

NOEC: 4,12 mg/kg


End point: Growth
Test period: 21 d
Species: Lactuca sativa (lettuce)
Method: OECD Guide-line 208
GLP: yes

NOEC: 111 mg/kg


End point: Growth
Test period: 21 d
Species: Dicotyledonae: Glycine max (soybean)
Method: OECD Guide-line 208
GLP: yes

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Toxicity to fish : LC50 (Danio rerio (zebra fish)): 4,2 mg/l
Exposure time: 96 h
Test Type: semi-static test
Analytical monitoring: yes
Method: OECD Test Guideline 203
GLP: yes
Remarks: The details of the toxic effect relate to the nominal
concentration.

Toxicity to daphnia and other : EC50 (Daphnia magna (Water flea)): 0,19 mg/l
aquatic invertebrates Exposure time: 48 h
Test Type: semi-static test
Analytical monitoring: yes
Method: OECD Test Guideline 202
GLP: yes
Remarks: The details of the toxic effect relate to the nominal
concentration.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 14(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Toxicity to algae : NOEC (other algae): 0,02 mg/l


22 - 212 µg/l
Exposure time: 28 d
Test Type: flow through
Analytical monitoring: yes
GLP: no

EC50 (Desmodesmus subspicatus (Scenedesmus


subspicatus)): 0,14 mg/l
End point: Growth rate
Exposure time: 72 h
Test Type: static test
Analytical monitoring: yes
Method: OECD Test Guideline 201
GLP: yes
Remarks: The details of the toxic effect relate to the nominal
concentration.

Toxicity to microorganisms : EC50 (activated sludge, domestic): 19 mg/l


End point: Bacteria toxicity (respiration inhibition)
Exposure time: 3 h
Test Type: aquatic
Analytical monitoring: no
Method: OECD Test Guideline 209
GLP: yes
Remarks: The details of the toxic effect relate to the nominal
concentration.

NOEC (Natural microorganism): 1.000 mg/l


End point: Nitrate formation rate
Exposure time: 28 d
Test Type: Soil
Analytical monitoring: no
Method: OECD 216
GLP: yes
Remarks: The details of the toxic effect relate to the nominal
concentration.

Toxicity to fish (Chronic : NOEC: 0,16 mg/l


toxicity) Exposure time: 28 d
Species: Danio rerio (zebra fish)
Test Type: flow through
Analytical monitoring: yes
Method: OECD Test Guideline 210
GLP: yes

Toxicity to daphnia and other : NOEC: 0,1 mg/l


aquatic invertebrates Exposure time: 21 d
(Chronic toxicity) End point: Reproduction rate
Species: Daphnia magna (Water flea)
Test Type: semi-static test
Analytical monitoring: yes
Method: OECD Test Guideline 211
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 15(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

GLP: yes
Remarks: The details of the toxic effect relate to the nominal
concentration.

Toxicity to soil dwelling : Test Type: artificial soil


organisms NOEC: 125 mg/kg
Exposure time: 56 d
End point: mortality
Species: Eisenia fetida (earthworms)
Method: OECD Test Guideline 222
GLP:yes
Remarks: The details of the toxic effect relate to the nominal
concentration.

Species: other soil dwelling arthropod


Remarks: The study is not necessary from a scientific
perspective.

Plant toxicity : NOEC: 3,2 mg/kg


Exposure time: 14 d
End point: Growth
Species: Lactuca sativa (lettuce)
Analytical monitoring: yes
Method: OECD Guide-line 208
GLP:yes
Remarks: The details of the toxic effect relate to the nominal
concentration.

NOEC: 3,2 mg/kg


Exposure time: 14 d
End point: Growth
Species: Avena sativa (oats)
Analytical monitoring: yes
Method: OECD Guide-line 208
GLP:yes
Remarks: The details of the toxic effect relate to the nominal
concentration.

Sediment toxicity : Remarks: The study is not necessary from a scientific


perspective.

Toxicity to terrestrial : Species: other avian


organisms Remarks: Not applicable

12.2 Persistence and degradability


Product:
Chemical Oxygen Demand : 767 mg/g
(COD) Method: DIN 38409-H-41

Dissolved organic carbon : 252 mg/g


(DOC) Method: DIN 38409 T. 3
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 16(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Biodegradability : Test Type: aerobic
Inoculum: activated sludge, non-adapted
Concentration: 50 mg/l
Result: Readily biodegradable.
Biodegradation: 87 %
Related to: CO2 formation in % of theoretical value
Exposure time: 28 d
Method: OECD Test Guideline 301B
GLP: yes

Test Type: aerobic


Inoculum: activated sludge, non-adapted
Concentration: 0,2 mg/l
Result: Readily biodegradable.
Biodegradation: approx. 100 %
Related to: DOC decrease
Exposure time: 26 d
Method: OECD Test Guideline 303A
GLP: yes

Physico-chemical : Remarks: Readily biodegradable, according to appropriate


removability OECD test.

Stability in water : Remarks: Not applicable

Photodegradation : Test Type: air


Remarks: Not applicable

Test Type: water


Remarks: Not applicable

Test Type: Soil


Remarks: Not applicable

12.3 Bioaccumulative potential


Product:
Bioaccumulation : Species: Fish
Bioconcentration factor (BCF): 18
Remarks: No bioaccumulation is to be expected (log Pow <=
4).

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Bioaccumulation : Remarks: Due to the low logPow bioaccumulation is not
expected
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 17(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

12.4 Mobility in soil


Product:
Distribution among : Remarks: The substance does not evaporate into the
environmental compartments atmosphere from the surface of water.

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Distribution among : adsorption
environmental compartments Medium: water - soil
Koc: log Koc: <= 5
Method: OECD Test Guideline 106
Remarks: Not expected to adsorb on soil.

12.5 Results of PBT and vPvB assessment


Product:
Assessment : Taking into account all available toxicty and ecotoxicity data, it
can be concluded that the ingredients of the mixture
described here do not fulfil the criteria to be classified as
either PBT or vPvB..

: This substance/mixture contains no components considered


to be either persistent, bioaccumulative and toxic (PBT), or
very persistent and very bioaccumulative (vPvB) at levels of
0.1% or higher..

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Assessment : Remarks: The substance does not meet the criteria for PBT or
vPvB substance.

12.6 Other adverse effects


Product:
Additional ecological : The product should not be allowed to enter drains, water
information courses or the soil.

Components:
N-(2-hydroxyethyl)-N,N-dimethyl alkyl-C12-14-(even numbered)-1-aminium chloride:
Environmental fate and : not available
pathways

Additional ecological : The product should not be allowed to enter drains, water
information courses or the soil.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 18(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

SECTION 13: Disposal considerations

13.1 Waste treatment methods


Product : In accordance with local authority regulations, take to special
waste incineration plant or underground disposal site

Contaminated packaging : Regulations concerning reuse or disposal of used packaging


materials must be observed.

SECTION 14: Transport information

Section 14.1. to 14.5.

ADR
UN no. UN 3265
Proper shipping name: Corrosive liquid, acidic, organic, n.o.s.
Hazard inducer(s): Fattyalkyl dimethylhydroxyethylammonium chloride
Class: 8
Primary risk: 8
Packing group: III
Hazard no. : 80
Environmental hazards: Special marking provision: environmentally hazardous
Remarks Shipment permitted
ADN
UN no. UN 3265
Proper shipping name: Corrosive liquid, acidic, organic, n.o.s.
Hazard inducer(s): Fattyalkyl dimethylhydroxyethylammonium chloride
Class: 8
Primary risk: 8
Packing group: III
Remarks Shipment permitted
RID
UN no. UN 3265
Proper shipping name: Corrosive liquid, acidic, organic, n.o.s.
Hazard inducer(s): Fattyalkyl dimethylhydroxyethylammonium chloride
Class: 8
Primary risk: 8
Packing group: III
Hazard no. : 80
Environmental hazards: Special marking provision: environmentally hazardous
Remarks Shipment permitted
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 19(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

IATA
UN no. UN 3265
Proper shipping name: Corrosive liquid, acidic, organic, n.o.s.
Hazard inducer(s): Fattyalkyl dimethylhydroxyethylammonium chloride
Class: 8
Primary risk: 8
Packing group: III
Environmental hazards: Special marking provision: environmentally hazardous
Remarks Shipment permitted
IMDG
UN no. UN 3265
Proper shipping name: Corrosive liquid, acidic, organic, n.o.s.
Hazard inducer(s): Fattyalkyl dimethylhydroxyethylammonium chloride
Class: 8
Primary risk: 8
Packing group: III
Remarks Shipment permitted
Marine pollutant: Marine Pollutant
EmS : F-A S-B

14.6. Special precautions for user


See sections 6 to 8 of this Safety Data Sheet.

14.7. Transport in bulk according to Annex II of MARPOL73/78 and the IBC Code (International
Bulk Chemicals Code)
No transport as bulk according IBC - Code.

SECTION 15: Regulatory information

15.1 Safety, health and environmental regulations/legislation specific for the substance or
mixture
Other regulations : The surfactant(s) contained in this mixture complies(comply)
with the biodegradability criteria as laid down in Regulation
(EC) No.648/2004 on detergents. Data to support this
assertion are held at the disposal of the competent authorities
of the Member States and will be made available to them, at
their direct request or at the request of a detergent
manufacturer.

15.2 Chemical safety assessment


Chemical Safety Assessments (CSAs) are available for the component substances contained in this
product.

SECTION 16: Other information

Full text of H-Statements


H302 : Harmful if swallowed.
H314 : Causes severe skin burns and eye damage.
H373 : May cause damage to organs through prolonged or repeated
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 20(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

exposure if swallowed.
H400 : Very toxic to aquatic life.
H411 : Toxic to aquatic life with long lasting effects.
Full text of other abbreviations
Acute Tox. : Acute toxicity
Aquatic Acute : Acute aquatic toxicity
Aquatic Chronic : Chronic aquatic toxicity
Skin Corr. : Skin corrosion
STOT RE : Specific target organ toxicity - repeated exposure
ADN - European Agreement concerning the International Carriage of Dangerous Goods by Inland
Waterways; ADR - European Agreement concerning the International Carriage of Dangerous
Goods by Road; AICS - Australian Inventory of Chemical Substances; ASTM - American Society
for the Testing of Materials; bw - Body weight; CLP - Classification Labelling Packaging
Regulation; Regulation (EC) No 1272/2008; CMR - Carcinogen, Mutagen or Reproductive
Toxicant; DIN - Standard of the German Institute for Standardisation; DSL - Domestic Substances
List (Canada); ECHA - European Chemicals Agency; EC-Number - European Community
number; ECx - Concentration associated with x% response; ELx - Loading rate associated with
x% response; EmS - Emergency Schedule; ENCS - Existing and New Chemical Substances
(Japan); ErCx - Concentration associated with x% growth rate response; GHS - Globally
Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research
on Cancer; IATA - International Air Transport Association; IBC - International Code for the
Construction and Equipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal
inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of
Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO -
International Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO -
International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50
- Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test
population (Median Lethal Dose); MARPOL - International Convention for the Prevention of
Pollution from Ships; n.o.s. - Not Otherwise Specified; NO(A)EC - No Observed (Adverse) Effect
Concentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable Effect
Loading Rate; NZIoC - New Zealand Inventory of Chemicals; OECD - Organization for Economic
Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention;
PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of
Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship;
REACH - Regulation (EC) No 1907/2006 of the European Parliament and of the Council
concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; RID -
Regulations concerning the International Carriage of Dangerous Goods by Rail; SADT - Self-
Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical
Substance Inventory; TRGS - Technical Rule for Hazardous Substances; TSCA - Toxic
Substances Control Act (United States); UN - United Nations; vPvB - Very Persistent and Very
Bioaccumulative
Further information
Other information : Observe national and local legal requirements

This information corresponds to the present state of our knowledge and is intended as a general
description of our products and their possible applications. Clariant makes no warranties, express
or implied, as to the information's accuracy, adequacy, sufficiency or freedom from defect and
assumes no liability in connection with any use of this information. Any user of this product is
responsible for determining the suitability of Clariant's products for its particular application.
Nothing included in this information waives any of Clariant's General Terms and Conditions of
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 21(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Sale, which control unless it agrees otherwise in writing. Any existing intellectual/industrial
property rights must be observed. Due to possible changes in our products and applicable
national and international regulations and laws, the status of our products could change. Material
Safety Data Sheets providing safety precautions, that should be observed when handling or
storing Clariant products, are available upon request and are provided in compliance with
applicable law. You should obtain and review the applicable Material Safety Data Sheet
information before handling any of these products. For additional information, please contact
Clariant.

REG_EU / EN
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 22(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Exposure scenario

Number Title
ES 1 Formulation or re-packing; Washing and cleaning products, Solid
PROC3, PROC5, PROC8b, PROC9, PROC15 - ERC2
Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl)
dimethyl, chlorides
ES 2 Formulation or re-packing; Washing and cleaning products, Liquid
PROC3, PROC5, PROC8b, PROC9, PROC15 - ERC2
Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl)
dimethyl, chlorides
ES 3 Industrial use; Washing and cleaning products, Solid
PROC3, PROC5, PROC8b, PROC10, PROC13 - ERC4
Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl)
dimethyl, chlorides
ES 4 Industrial use; Washing and cleaning products, Liquid
PROC1, PROC3, PROC5, PROC8b, PROC10, PROC13 - ERC4
Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl)
dimethyl, chlorides
ES 5 Professional use; Washing and cleaning products, Solid
PROC3, PROC5, PROC8a, PROC8b, PROC9, PROC10, PROC13 - ERC8a
Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl)
dimethyl, chlorides
ES 6 Professional use; Washing and cleaning products, Liquid
PROC1, PROC3, PROC5, PROC8a, PROC8b, PROC9, PROC10, PROC13 - ERC8a
Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl)
dimethyl, chlorides
ES 7 Consumer use; Washing and cleaning products, Liquid
PC35 - ERC8a
Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl)
dimethyl, chlorides
ES 8 Consumer use; Washing and cleaning products, Solid
PC35 - ERC8a
Quaternary ammonium compounds, C12-14, even numbered, alkyl(hydroxyethyl)
dimethyl, chlorides

1. ES 1: Formulation or re-packing; Washing and cleaning


products, Solid
1.1. Titles of Contributing scenarios (CS)
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 23(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Environment
CS1: Formulation or re-packing (Formulation into mixture) ERC2
Workers
CS2: Formulation or re-packing (Manufacture or formulation in the chemical PROC3
industry in closed batch processes with occasional controlled exposure
or processes with equivalent containment condition)
CS3: Formulation or re-packing (Mixing or blending in batch processes) PROC5
CS4: Formulation or re-packing (Transfer of substance or mixture PROC8b
(charging/discharging) at dedicated facilities)
CS5: Formulation or re-packing (Transfer of substance or mixture PROC8b
(charging/discharging) at dedicated facilities)
CS6: Formulation or re-packing (Transfer of substance or mixture into small PROC9
containers (dedicated filling line, including weighing))
CS7: Formulation or re-packing (Transfer of substance or mixture into small PROC9
containers (dedicated filling line, including weighing))
CS8: Formulation or re-packing (Use as laboratory reagent) PROC15

1.2. ES 1 Conditions of use affecting exposure


1.2.1 ES 1 - CS 1: Control of environmental exposure: Formulation or re-packing
(Formulation into mixture) (ERC2)

Amount used
Annual amount per site : <= 3200 tonnes/year
Daily amount per site : <= 10670 kg/day

Frequency and duration of use


Continuous exposure : 300 days per year

Environment factors not influenced by risk management


Flow rate of receiving surface : 18.000 m3/d
water

Conditions and measures related to sewage treatment plant


Type of Sewage Treatment Plant : Municipal Sewage Treatment Plant
Flow rate of sewage treatment : 2.000 m3/d
plant effluent
Effectiveness (of a measure) : 99 %

Waste management measures


Disposal methods : Dispose of waste product or used containers according to
local regulations.

1.2.2 ES 1 - CS 2: Control of worker exposure: Formulation or re-packing


(Manufacture or formulation in the chemical industry in closed batch processes with
occasional controlled exposure or processes with equivalent containment condition)
(PROC3)
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 24(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Remarks : Sampling

Product characteristics
Concentration of the Substance in : > 25 %
Mixture/Article

Physical Form (at time of use) : Solid, low dustiness


Remarks : Covers use at ambient temperatures., Covers solid products
only.

Frequency and duration of use


Exposure duration : <8h

Human factors not influenced by risk management


Dermal exposure : Palm of one hand
Covers skin contact area up to : 240 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Manufacture or formulation in the chemical industry in closed
batch processes with occasional controlled exposure or
processes with equivalent containment condition
Provide a basic standard of general ventilation (1 to 3 air
changes per hour).

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
measures
Effectiveness (of a measure) : >= 90 %

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Use suitable eye protection.
Effectiveness (of a measure) : >= 80 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

1.2.3 ES 1 - CS 3: Control of worker exposure: Formulation or re-packing (Mixing or


blending in batch processes) (PROC5)

Product characteristics
Concentration of the Substance in : > 25 %
Mixture/Article
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 25(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Physical Form (at time of use) : Solid, low dustiness


Remarks : Covers use at ambient temperatures., Covers solid products
only.

Frequency and duration of use


Exposure duration : <8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Provide a basic standard of general ventilation (1 to 3 air
changes per hour).

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
measures
Effectiveness (of a measure) : >= 90 %

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with specific activity training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 95 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

1.2.4 ES 1 - CS 4: Control of worker exposure: Formulation or re-packing (Transfer of


substance or mixture (charging/discharging) at dedicated facilities) (PROC8b)

Remarks : Product delivery

Product characteristics
Concentration of the Substance in : > 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 40 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 26(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 4h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Transfer of liquid products - falling : > 1000 L/min, ART


liquids

Risk Management Measures


Type of Application (Use) : Splash loading
Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Ensure that the distance from worker to task is greater than 1
m.
Handling that reduces contact between product and adjacent
air.
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Use in semi-closed process with opportunity for exposure

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
measures
Effectiveness (of a measure) : >= 50 %

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with specific activity training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 95 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

1.2.5 ES 1 - CS 5: Control of worker exposure: Formulation or re-packing (Transfer of


substance or mixture (charging/discharging) at dedicated facilities) (PROC8b)

Remarks : Material transfers

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 27(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Physical Form (at time of use) : Solid, low dustiness


Remarks : Covers solid products only., Covers use at ambient
temperatures.

Frequency and duration of use


Exposure duration : 4h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Use in semi-closed process with opportunity for exposure
Provide a basic standard of general ventilation (1 to 3 air
changes per hour).

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
measures
Effectiveness (of a measure) : >= 95 %

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with specific activity training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 95 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

1.2.6 ES 1 - CS 6: Control of worker exposure: Formulation or re-packing (Transfer of


substance or mixture into small containers (dedicated filling line, including weighing))
(PROC9)

Remarks : Product delivery

Product characteristics
Concentration of the Substance in : > 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 40 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 28(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Physical Form (at time of use) : Solid, Powder products


Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : <8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Transfer of liquid products - falling : 100 - 1000 L/min, ART


liquids

Risk Management Measures


Type of Application (Use) : Splash loading
Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Ensure that the distance from worker to task is greater than 1
m.
Handling that reduces contact between product and adjacent
air.
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Use in semi-closed process with opportunity for exposure

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
measures
Effectiveness (of a measure) : >= 50 %

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with ‘basic’ employee training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 90 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

1.2.7 ES 1 - CS 7: Control of worker exposure: Formulation or re-packing (Transfer of


substance or mixture into small containers (dedicated filling line, including weighing))
(PROC9)

Remarks : Material transfers

Product characteristics
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 29(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Concentration of the Substance in : >= 5 - <= 25 %


Mixture/Article

Physical Form (at time of use) : Solid, low dustiness


Remarks : Covers solid products only., Covers use at ambient
temperatures.

Frequency and duration of use


Exposure duration : <8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Use in semi-closed process with opportunity for exposure
Provide a basic standard of general ventilation (1 to 3 air
changes per hour).

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
measures
Effectiveness (of a measure) : >= 90 %

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with ‘basic’ employee training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 90 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

1.2.8 ES 1 - CS 8: Control of worker exposure: Formulation or re-packing (Use as


laboratory reagent) (PROC15)

Product characteristics
Concentration of the Substance in : > 25 %
Mixture/Article

Physical Form (at time of use) : Solid, low dustiness


Remarks : Covers solid products only., Covers use at ambient
temperatures.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 30(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Frequency and duration of use


Exposure duration : 4h

Human factors not influenced by risk management


Dermal exposure : Palm of one hand
Covers skin contact area up to : 240 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Provide a basic standard of general ventilation (1 to 3 air
changes per hour).

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
measures
Effectiveness (of a measure) : >= 90 %

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Use suitable eye protection.
Effectiveness (of a measure) : >= 80 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

1.3. ES 1 Exposure estimation and reference to its source


1.3.1 ES 1 - CS 1: Environmental release and exposure: Formulation or re-packing
(Formulation into mixture) (ERC2)

Release route Release rate Release estimation method


Water 0,6 kg/day EUSES v2.1
Air 0 kg/day EUSES v2.1
Soil 0 kg/day EUSES v2.1

Protection target Exposure estimation and reference to its source RCR


(based on EUSES v2.1)
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 31(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Freshwater 0,000709 mg/L 0,177


Freshwater sediment 0,857 mg/kg dry weight 0,177
Marine water 0,0000691 mg/L 0,173
Marine sediment 0,0853 mg/kg dry weight 0,173
Sewage treatment plant. 0,0030 mg/L 0,0158
Indirect exposure to humans 0,0000383 mg/kg bw/day < 0,01
via the environment
Soil 0,0000081 mg/kg dry weight < 0,01

1.3.2 ES 1 - CS 2: Worker exposure: Formulation or re-packing (Manufacture or


formulation in the chemical industry in closed batch processes with occasional
controlled exposure or processes with equivalent containment condition) (PROC3)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,01 mg/m³ (ECETOC TRA worker V3, Tier 1) < 0,01
- systemic
Worker - inhalative, long-term 0,01 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,01
- local
Worker - inhalative, short-term 0,04 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,04
- local
Worker - dermal, long-term - 0,138 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,11
systemic
Worker - combined, long-term 0,115
- systemic

1.3.3 ES 1 - CS 3: Worker exposure: Formulation or re-packing (Mixing or blending in


batch processes) (PROC5)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,05 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,023
- systemic
Worker - inhalative, long-term 0,05 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,05
- local
Worker - inhalative, short-term 0,2 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,2
- local
Worker - dermal, long-term - 0,686 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,548
systemic
Worker - combined, long-term 0,571
- systemic

1.3.4 ES 1 - CS 4: Worker exposure: Formulation or re-packing (Transfer of


substance or mixture (charging/discharging) at dedicated facilities) (PROC8b)

Route of exposure and type Exposure estimate RCR


of effects
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 32(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Worker - inhalative, long-term 0,15 mg/m³ (ART, Tier 2, Raw material delivery) 0,068
- systemic
Worker - inhalative, long-term 0,15 mg/m³ (ART, Tier 2, Raw material delivery) 0,15
- local
Worker - inhalative, short-term 0,3 mg/m³ (ART, Tier 2, Raw material delivery) 0,3
- local
Worker - dermal, long-term - 0,411 mg/kg bw/day (ECETOC TRA worker V3, Tier 1, 0,329
systemic Raw material delivery)
Worker - combined, long-term 0,397
- systemic

1.3.5 ES 1 - CS 5: Worker exposure: Formulation or re-packing (Transfer of


substance or mixture (charging/discharging) at dedicated facilities) (PROC8b)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,002 mg/m³ (ECETOC TRA worker V3, Material < 0,01
- systemic transfers)
Worker - inhalative, long-term 0,002 mg/m³ (ECETOC TRA worker V3, Material < 0,01
- local transfers)
Worker - inhalative, short-term 0,012 mg/m³ (ECETOC TRA worker V3, Material 0,012
- local transfers)
Worker - dermal, long-term - 0,247 mg/kg bw/day (ECETOC TRA worker V3, Material 0,197
systemic transfers)
Worker - combined, long-term 0,198
- systemic

1.3.6 ES 1 - CS 6: Worker exposure: Formulation or re-packing (Transfer of


substance or mixture into small containers (dedicated filling line, including weighing))
(PROC9)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,09 mg/m³ (ART, Tier 2, Raw material delivery) 0,041
- systemic
Worker - inhalative, long-term 0,09 mg/m³ (ART, Tier 2, Raw material delivery) 0,09
- local
Worker - inhalative, short-term 0,18 mg/m³ (ART, Tier 2, Raw material delivery) 0,18
- local
Worker - dermal, long-term - 0,686 mg/kg bw/day (ECETOC TRA worker V3, Tier 1, 0,549
systemic Raw material delivery)
Worker - combined, long-term 0,59
- systemic

1.3.7 ES 1 - CS 7: Worker exposure: Formulation or re-packing (Transfer of


substance or mixture into small containers (dedicated filling line, including weighing))
(PROC9)
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 33(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,006 mg/m³ (ECETOC TRA worker V3, Material < 0,01
- systemic transfers)
Worker - inhalative, long-term 0,006 mg/m³ (ECETOC TRA worker V3, Material < 0,01
- local transfers)
Worker - inhalative, short-term 0,024 mg/m³ (ECETOC TRA worker V3, Material 0,024
- local transfers)
Worker - dermal, long-term - 0,412 mg/kg bw/day (ECETOC TRA worker V3, Material 0,329
systemic transfers)
Worker - combined, long-term 0,332
- systemic

1.3.8 ES 1 - CS 8: Worker exposure: Formulation or re-packing (Use as laboratory


reagent) (PROC15)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,006 mg/m³ (ECETOC TRA worker V3, Tier 1) < 0,01
- systemic
Worker - inhalative, long-term 0,006 mg/m³ (ECETOC TRA worker V3, Tier 1) < 0,01
- local
Worker - inhalative, short-term 0,04 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,04
- local
Worker - dermal, long-term - 0,041 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,033
systemic
Worker - combined, long-term 0,035
- systemic

1.4. ES 1 Guidance to Downstream User to evaluate whether he


works inside the boundaries set by the Exposure Scenario
ECHA guidance for downstream users
Section 2

2. ES 2: Formulation or re-packing; Washing and cleaning


products, Liquid
2.1. Titles of Contributing scenarios (CS)

Environment
CS1: Formulation or re-packing (Formulation into mixture) ERC2
Workers
CS2: Formulation or re-packing (Manufacture or formulation in the chemical PROC3
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 34(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

industry in closed batch processes with occasional controlled exposure


or processes with equivalent containment condition)
CS3: Formulation or re-packing (Mixing or blending in batch processes) PROC5
CS4: Formulation or re-packing (Transfer of substance or mixture PROC8b
(charging/discharging) at dedicated facilities)
CS5: Formulation or re-packing (Transfer of substance or mixture PROC8b
(charging/discharging) at dedicated facilities)
CS6: Formulation or re-packing (Transfer of substance or mixture into small PROC9
containers (dedicated filling line, including weighing))
CS7: Formulation or re-packing (Transfer of substance or mixture into small PROC9
containers (dedicated filling line, including weighing))
CS8: Formulation or re-packing (Use as laboratory reagent) PROC15

2.2. ES 2 Conditions of use affecting exposure


2.2.1 ES 2 - CS 1: Control of environmental exposure: Formulation or re-packing
(Formulation into mixture) (ERC2)

Amount used
Annual amount per site : <= 3200 tonnes/year
Daily amount per site : <= 10670 kg/day

Frequency and duration of use


Continuous exposure : 300 days per year

Environment factors not influenced by risk management


Flow rate of receiving surface : 18.000 m3/d
water

Conditions and measures related to sewage treatment plant


Type of Sewage Treatment Plant : Municipal Sewage Treatment Plant
Flow rate of sewage treatment : 2.000 m3/d
plant effluent
Effectiveness (of a measure) : 99 %

Waste management measures


Disposal methods : Dispose of waste product or used containers according to
local regulations.

2.2.2 ES 2 - CS 2: Control of worker exposure: Formulation or re-packing


(Manufacture or formulation in the chemical industry in closed batch processes with
occasional controlled exposure or processes with equivalent containment condition)
(PROC3)

Remarks : Sampling

Product characteristics
Concentration of the Substance in : > 25 %
Mixture/Article ECETOC TRA worker V3
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 35(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Concentration of the Substance in : <= 40 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Palm of one hand
Covers skin contact area up to : 240 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Transfer of liquid products - falling : 1 - 10 L/min, ART


liquids

Risk Management Measures


Type of Application (Use) : Splash loading
Open systems
Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Manufacture or formulation in the chemical industry in closed
batch processes with occasional controlled exposure or
processes with equivalent containment condition

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Use suitable eye protection.
Effectiveness (of a measure) : >= 80 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

2.2.3 ES 2 - CS 3: Control of worker exposure: Formulation or re-packing (Mixing or


blending in batch processes) (PROC5)

Product characteristics
Concentration of the Substance in : > 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 40 %


Mixture/Article ART
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 36(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Physical Form (at time of use) : Liquid, Low viscosity


Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : <8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Handling of contaminated objects : 1 - 3 m2, Activities with open liquid surfaces or open
reservoirs - activity with agitated surfaces, ART

Risk Management Measures


Type of Application (Use) : Splash loading
Open systems
Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Ensure that the distance from worker to task is greater than 1
m.
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
measures
Effectiveness (of a measure) : >= 50 %

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with specific activity training.
Effectiveness (of a measure) : >= 95 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

2.2.4 ES 2 - CS 4: Control of worker exposure: Formulation or re-packing (Transfer of


substance or mixture (charging/discharging) at dedicated facilities) (PROC8b)

Remarks : Product delivery

Product characteristics
Concentration of the Substance in : > 25 %
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 37(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 40 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 4h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Transfer of liquid products - falling : > 1000 L/min, ART


liquids

Risk Management Measures


Type of Application (Use) : Splash loading
Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Ensure that the distance from worker to task is greater than 1
m.
Handling that reduces contact between product and adjacent
air.
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Use in semi-closed process with opportunity for exposure

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
measures
Effectiveness (of a measure) : >= 50 %

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with specific activity training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 95 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

2.2.5 ES 2 - CS 5: Control of worker exposure: Formulation or re-packing (Transfer of


SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 38(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

substance or mixture (charging/discharging) at dedicated facilities) (PROC8b)

Remarks : Material transfers

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 10 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 4h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Transfer of liquid products - falling : > 1000 L/min, ART


liquids

Risk Management Measures


Type of Application (Use) : Splash loading
Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Ensure that the distance from worker to task is greater than 1
m.
Handling that reduces contact between product and adjacent
air.
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Use in semi-closed process with opportunity for exposure

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
measures
Effectiveness (of a measure) : >= 50 %

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with specific activity training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 95 %
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 39(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

2.2.6 ES 2 - CS 6: Control of worker exposure: Formulation or re-packing (Transfer of


substance or mixture into small containers (dedicated filling line, including weighing))
(PROC9)

Remarks : Product delivery

Product characteristics
Concentration of the Substance in : > 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 40 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : <8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Transfer of liquid products - falling : 100 - 1000 L/min, ART


liquids

Risk Management Measures


Type of Application (Use) : Splash loading
Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Ensure that the distance from worker to task is greater than 1
m.
Handling that reduces contact between product and adjacent
air.
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Use in semi-closed process with opportunity for exposure

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 40(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

measures
Effectiveness (of a measure) : >= 50 %

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with ‘basic’ employee training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 90 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

2.2.7 ES 2 - CS 7: Control of worker exposure: Formulation or re-packing (Transfer of


substance or mixture into small containers (dedicated filling line, including weighing))
(PROC9)

Remarks : Material transfers

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 10 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : <8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Transfer of liquid products - falling : 100 - 1000 L/min, ART


liquids

Risk Management Measures


Type of Application (Use) : Splash loading
Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Ensure that the distance from worker to task is greater than 1
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 41(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

m.
Handling that reduces contact between product and adjacent
air.
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Use in semi-closed process with opportunity for exposure

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
measures
Effectiveness (of a measure) : >= 50 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Use suitable eye protection.
Effectiveness (of a measure) : >= 80 %

2.2.8 ES 2 - CS 8: Control of worker exposure: Formulation or re-packing (Use as


laboratory reagent) (PROC15)

Product characteristics
Concentration of the Substance in : > 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 40 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 4h

Human factors not influenced by risk management


Dermal exposure : Palm of one hand
Covers skin contact area up to : 240 cm²
Remarks : Activities with open liquid surfaces or open reservoirs - activity
with undisturbed surfaces (no aerosol formation)

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Ventilation rate per hour : 1

Handling of contaminated objects : 0,1 - 0,3 m2, Activities with open liquid surfaces or open
reservoirs - activity with undisturbed surfaces (no aerosol
formation), ART

Risk Management Measures


SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 42(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Organisational measures to : Advanced (industrial) exposure controls assumed.


prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures

Exposure routes : inhalative


Technical conditions and : Handle in a fume cupboard or under extract ventilation.
measures
Effectiveness (of a measure) : >= 99 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Use suitable eye protection.
Effectiveness (of a measure) : >= 80 %

2.3. ES 2 Exposure estimation and reference to its source


2.3.1 ES 2 - CS 1: Environmental release and exposure: Formulation or re-packing
(Formulation into mixture) (ERC2)

Release route Release rate Release estimation method


Water 0,6 kg/day EUSES v2.1
Air 0 kg/day EUSES v2.1
Soil 0 kg/day EUSES v2.1

Protection target Exposure estimation and reference to its source RCR


(based on EUSES v2.1)
Freshwater 0,000709 mg/L 0,177
Freshwater sediment 0,857 mg/kg dry weight 0,177
Marine water 0,0000691 mg/L 0,173
Marine sediment 0,0853 mg/kg dry weight 0,173
Sewage treatment plant. 0,0030 mg/L 0,0158
Indirect exposure to humans 0,0000383 mg/kg bw/day < 0,01
via the environment
Soil 0,0000081 mg/kg dry weight < 0,01

2.3.2 ES 2 - CS 2: Worker exposure: Formulation or re-packing (Manufacture or


formulation in the chemical industry in closed batch processes with occasional
controlled exposure or processes with equivalent containment condition) (PROC3)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,021 mg/m³ (ART, Tier 2) < 0,01
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 43(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

- systemic
Worker - inhalative, long-term 0,021 mg/m³ (ART, Tier 2) 0,021
- local
Worker - inhalative, short-term 0,17 mg/m³ (ART, Tier 2) 0,17
- local
Worker - dermal, long-term - 0,028 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,022
systemic
Worker - combined, long-term 0,032
- systemic

2.3.3 ES 2 - CS 3: Worker exposure: Formulation or re-packing (Mixing or blending in


batch processes) (PROC5)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,34 mg/m³ (ART, Tier 2) 0,154
- systemic
Worker - inhalative, long-term 0,34 mg/m³ (ART, Tier 2) 0,34
- local
Worker - inhalative, short-term 0,68 mg/m³ (ART, Tier 2) 0,68
- local
Worker - dermal, long-term - 0,686 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,548
systemic
Worker - combined, long-term 0,703
- systemic

2.3.4 ES 2 - CS 4: Worker exposure: Formulation or re-packing (Transfer of


substance or mixture (charging/discharging) at dedicated facilities) (PROC8b)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,15 mg/m³ (ART, Tier 2, Raw material delivery) 0,068
- systemic
Worker - inhalative, long-term 0,15 mg/m³ (ART, Tier 2, Raw material delivery) 0,15
- local
Worker - inhalative, short-term 0,3 mg/m³ (ART, Tier 2, Raw material delivery) 0,3
- local
Worker - dermal, long-term - 0,411 mg/kg bw/day (ECETOC TRA worker V3, Tier 1, 0,329
systemic Raw material delivery)
Worker - combined, long-term 0,397
- systemic

2.3.5 ES 2 - CS 5: Worker exposure: Formulation or re-packing (Transfer of


substance or mixture (charging/discharging) at dedicated facilities) (PROC8b)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,038 mg/m³ (ART, Material transfers) 0,017
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 44(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

- systemic
Worker - inhalative, long-term 0,038 mg/m³ (ART, Material transfers) 0,038
- local
Worker - inhalative, short-term 0,076 mg/m³ (ART, Material transfers) 0,076
- local
Worker - dermal, long-term - 0,247 mg/kg bw/day (ECETOC TRA worker V3, Material 0,197
systemic transfers)
Worker - combined, long-term 0,215
- systemic

2.3.6 ES 2 - CS 6: Worker exposure: Formulation or re-packing (Transfer of


substance or mixture into small containers (dedicated filling line, including weighing))
(PROC9)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,09 mg/m³ (ART, Tier 2, Raw material delivery) 0,041
- systemic
Worker - inhalative, long-term 0,09 mg/m³ (ART, Tier 2, Raw material delivery) 0,09
- local
Worker - inhalative, short-term 0,18 mg/m³ (ART, Tier 2, Raw material delivery) 0,18
- local
Worker - dermal, long-term - 0,686 mg/kg bw/day (ECETOC TRA worker V3, Tier 1, 0,549
systemic Raw material delivery)
Worker - combined, long-term 0,59
- systemic

2.3.7 ES 2 - CS 7: Worker exposure: Formulation or re-packing (Transfer of


substance or mixture into small containers (dedicated filling line, including weighing))
(PROC9)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,022 mg/m³ (ART, Material transfers) < 0,01
- systemic
Worker - inhalative, long-term 0,022 mg/m³ (ART, Material transfers) 0,022
- local
Worker - inhalative, short-term 0,044 mg/m³ (ART, Material transfers) 0,044
- local
Worker - dermal, long-term - 0,823 mg/kg bw/day (ECETOC TRA worker V3, Material 0,659
systemic transfers)
Worker - combined, long-term 0,669
- systemic

2.3.8 ES 2 - CS 8: Worker exposure: Formulation or re-packing (Use as laboratory


reagent) (PROC15)
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 45(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,00014 mg/m³ (ART, Tier 2) < 0,01
- systemic
Worker - inhalative, long-term 0,00014 mg/m³ (ART, Tier 2) < 0,01
- local
Worker - inhalative, short-term 0,00028 mg/m³ (ART, Tier 2) < 0,01
- local
Worker - dermal, long-term - 0,041 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,033
systemic
Worker - combined, long-term 0,033
- systemic

2.4. ES 2 Guidance to Downstream User to evaluate whether he


works inside the boundaries set by the Exposure Scenario
ECHA guidance for downstream users
Section 2

3. ES 3: Industrial use; Washing and cleaning products,


Solid
3.1. Titles of Contributing scenarios (CS)

Environment
CS1: Industrial use (Use of non-reactive processing aid at industrial site (no ERC4
inclusion into or onto article))
Workers
CS2: Industrial use (Manufacture or formulation in the chemical industry in PROC3
closed batch processes with occasional controlled exposure or
processes with equivalent containment condition)
CS3: Industrial use (Mixing or blending in batch processes) PROC5
CS4: Industrial use (Transfer of substance or mixture (charging/discharging) PROC8b
at dedicated facilities)
CS5: Industrial use (Roller application or brushing) PROC10
CS6: Industrial use (Treatment of articles by dipping and pouring) PROC13

3.2. ES 3 Conditions of use affecting exposure


3.2.1 ES 3 - CS 1: Control of environmental exposure: Industrial use (Use of non-
reactive processing aid at industrial site (no inclusion into or onto article)) (ERC4)
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 46(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Amount used
Annual amount per site : <= 0,09 tonnes/year
Daily amount per site : <= 0,41 kg/day

Frequency and duration of use


Continuous exposure : 220 days per year

Environment factors not influenced by risk management


Flow rate of receiving surface : 18.000 m3/d
water

Conditions and measures related to sewage treatment plant


Type of Sewage Treatment Plant : Municipal Sewage Treatment Plant
Flow rate of sewage treatment : 2.000 m3/d
plant effluent
Effectiveness (of a measure) : 99 %

Waste management measures


Disposal methods : Dispose of waste product or used containers according to
local regulations.

3.2.2 ES 3 - CS 2: Control of worker exposure: Industrial use (Manufacture or


formulation in the chemical industry in closed batch processes with occasional
controlled exposure or processes with equivalent containment condition) (PROC3)

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article

Physical Form (at time of use) : Solid, low dustiness


Remarks : Covers use at ambient temperatures., Covers solid products
only.

Frequency and duration of use


Exposure duration : <8h

Human factors not influenced by risk management


Dermal exposure : Palm of one hand
Covers skin contact area up to : 240 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Manufacture or formulation in the chemical industry in closed
batch processes with occasional controlled exposure or
processes with equivalent containment condition
Provide a basic standard of general ventilation (1 to 3 air
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 47(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

changes per hour).

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Use suitable eye protection.
Effectiveness (of a measure) : >= 80 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

3.2.3 ES 3 - CS 3: Control of worker exposure: Industrial use (Mixing or blending in


batch processes) (PROC5)

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article

Physical Form (at time of use) : Solid, low dustiness


Remarks : Covers use at ambient temperatures., Covers solid products
only.

Frequency and duration of use


Exposure duration : <8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Provide a good standard of general ventilation (not less than 3
to 5 air changes per hour).

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with specific activity training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 95 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

3.2.4 ES 3 - CS 4: Control of worker exposure: Industrial use (Transfer of substance


or mixture (charging/discharging) at dedicated facilities) (PROC8b)
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 48(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article

Physical Form (at time of use) : Solid, low dustiness


Remarks : Covers use at ambient temperatures., Covers solid products
only.

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Provide a basic standard of general ventilation (1 to 3 air
changes per hour).
Use in semi-closed process with opportunity for exposure

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with specific activity training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 95 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

3.2.5 ES 3 - CS 5: Control of worker exposure: Industrial use (Roller application or


brushing) (PROC10)

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 10 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 49(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Frequency and duration of use


Exposure duration : <8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Roller, spreader, flow application : > 3 m²/h

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with specific activity training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 95 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

3.2.6 ES 3 - CS 6: Control of worker exposure: Industrial use (Treatment of articles


by dipping and pouring) (PROC13)

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 10 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 4h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 50(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Handling of contaminated objects : > 3 m2, Activities with open liquid surfaces or open reservoirs
- activity with agitated surfaces, ART

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
measures
Effectiveness (of a measure) : >= 50 %

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with ‘basic’ employee training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 90 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

3.3. ES 3 Exposure estimation and reference to its source


3.3.1 ES 3 - CS 1: Environmental release and exposure: Industrial use (Use of non-
reactive processing aid at industrial site (no inclusion into or onto article)) (ERC4)

Release route Release rate Release estimation method


Water 0,41 kg/day EUSES v2.1
Air 0 kg/day EUSES v2.1
Soil 0 kg/day EUSES v2.1

Protection target Exposure estimation and reference to its source RCR


(based on EUSES v2.1)
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 51(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Freshwater 0,000616 mg/L 0,154


Freshwater sediment 0,745 mg/kg dry weight 0,154
Marine water 0,0000598 mg/L 0,15
Marine sediment 0,0723 mg/kg dry weight 0,15
Sewage treatment plant. 0,00205 mg/L 0,0108
Indirect exposure to humans 0,0000332 mg/kg bw/day < 0,01
via the environment
Soil 0,0991 mg/kg dry weight 0,163

3.3.2 ES 3 - CS 2: Worker exposure: Industrial use (Manufacture or formulation in the


chemical industry in closed batch processes with occasional controlled exposure or
processes with equivalent containment condition) (PROC3)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,06 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,027
- systemic
Worker - inhalative, long-term 0,06 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,06
- local
Worker - inhalative, short-term 0,24 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,24
- local
Worker - dermal, long-term - 0,083 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,066
systemic
Worker - combined, long-term 0,094
- systemic

3.3.3 ES 3 - CS 3: Worker exposure: Industrial use (Mixing or blending in batch


processes) (PROC5)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,21 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,095
- systemic
Worker - inhalative, long-term 0,21 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,21
- local
Worker - inhalative, short-term 0,84 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,84
- local
Worker - dermal, long-term - 0,411 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,329
systemic
Worker - combined, long-term 0,425
- systemic

3.3.4 ES 3 - CS 4: Worker exposure: Industrial use (Transfer of substance or mixture


(charging/discharging) at dedicated facilities) (PROC8b)

Route of exposure and type Exposure estimate RCR


of effects
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 52(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Worker - inhalative, long-term 0,012 mg/m³ (ECETOC TRA worker V3, Tier 1) < 0,01
- systemic
Worker - inhalative, long-term 0,012 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,012
- local
Worker - inhalative, short-term 0,24 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,24
- local
Worker - dermal, long-term - 0,082 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,066
systemic
Worker - combined, long-term 0,071
- systemic

3.3.5 ES 3 - CS 5: Worker exposure: Industrial use (Roller application or brushing)


(PROC10)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,46 mg/m³ (ART, Tier 2) 0,209
- systemic
Worker - inhalative, long-term 0,46 mg/m³ (ART, Tier 2) 0,46
- local
Worker - inhalative, short-term 0,92 mg/m³ (ART, Tier 2) 0,92
- local
Worker - dermal, long-term - 0,823 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,658
systemic
Worker - combined, long-term 0,867
- systemic

3.3.6 ES 3 - CS 6: Worker exposure: Industrial use (Treatment of articles by dipping


and pouring) (PROC13)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,34 mg/m³ (ART, Tier 2) 0,154
- systemic
Worker - inhalative, long-term 0,34 mg/m³ (ART, Tier 2) 0,34
- local
Worker - inhalative, short-term 0,68 mg/m³ (ART, Tier 2) 0,68
- local
Worker - dermal, long-term - 0,494 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,395
systemic
Worker - combined, long-term 0,549
- systemic

3.4. ES 3 Guidance to Downstream User to evaluate whether he


works inside the boundaries set by the Exposure Scenario
ECHA guidance for downstream users
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 53(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Section 2

4. ES 4: Industrial use; Washing and cleaning products,


Liquid
4.1. Titles of Contributing scenarios (CS)

Environment
CS1: Industrial use (Use of non-reactive processing aid at industrial site (no ERC4
inclusion into or onto article))
Workers
CS2: Industrial use (Chemical production or refinery in closed process without PROC1
likelihood of exposure or processes with equivalent containment
conditions)
CS3: Industrial use (Manufacture or formulation in the chemical industry in PROC3
closed batch processes with occasional controlled exposure or
processes with equivalent containment condition)
CS4: Industrial use (Mixing or blending in batch processes) PROC5
CS5: Industrial use (Transfer of substance or mixture (charging/discharging) PROC8b
at dedicated facilities)
CS6: Industrial use (Roller application or brushing) PROC10
CS7: Industrial use (Treatment of articles by dipping and pouring) PROC13

4.2. ES 4 Conditions of use affecting exposure


4.2.1 ES 4 - CS 1: Control of environmental exposure: Industrial use (Use of non-
reactive processing aid at industrial site (no inclusion into or onto article)) (ERC4)

Amount used
Annual amount per site : <= 0,09 tonnes/year
Daily amount per site : <= 0,41 kg/day

Frequency and duration of use


Continuous exposure : 220 days per year

Environment factors not influenced by risk management


Flow rate of receiving surface : 18.000 m3/d
water

Conditions and measures related to sewage treatment plant


Type of Sewage Treatment Plant : Municipal Sewage Treatment Plant
Flow rate of sewage treatment : 2.000 m3/d
plant effluent
Effectiveness (of a measure) : 99 %
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 54(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Waste management measures


Disposal methods : Dispose of waste product or used containers according to
local regulations.

4.2.2 ES 4 - CS 2: Control of worker exposure: Industrial use (Chemical production or


refinery in closed process without likelihood of exposure or processes with equivalent
containment conditions) (PROC1)

Remarks : Spraying
Closed systems

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 10 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 8h

Human factors not influenced by risk management


Dermal exposure : Palm of one hand
Covers skin contact area up to : 240 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Handling of contaminated objects : > 3 m2

Contamination : > 90 %, ART

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Chemical production or refinery in closed process without
likelihood of exposure or processes with equivalent
containment conditions

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with specific activity training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 95 %
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 55(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

4.2.3 ES 4 - CS 3: Control of worker exposure: Industrial use (Manufacture or


formulation in the chemical industry in closed batch processes with occasional
controlled exposure or processes with equivalent containment condition) (PROC3)

Remarks : Sampling

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 10 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Palm of one hand
Covers skin contact area up to : 240 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Transfer of liquid products - falling : 1 - 10 L/min, ART


liquids

Risk Management Measures


Type of Application (Use) : Splash loading
Open systems
Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Manufacture or formulation in the chemical industry in closed
batch processes with occasional controlled exposure or
processes with equivalent containment condition

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Use suitable eye protection.
Effectiveness (of a measure) : >= 80 %
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 56(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

4.2.4 ES 4 - CS 4: Control of worker exposure: Industrial use (Mixing or blending in


batch processes) (PROC5)

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 10 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Handling of contaminated objects : 1 - 3 m2, Activities with open liquid surfaces or open
reservoirs - activity with agitated surfaces, ART

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Ensure that the distance from worker to task is greater than 1
m.
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with specific activity training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 95 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 57(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

characterisation.

4.2.5 ES 4 - CS 5: Control of worker exposure: Industrial use (Transfer of substance


or mixture (charging/discharging) at dedicated facilities) (PROC8b)

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 10 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Transfer of liquid products - falling : > 1000 L/min, ART


liquids

Risk Management Measures


Type of Application (Use) : Splash loading
Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Ensure that the distance from worker to task is greater than 1
m.
Handling that reduces contact between product and adjacent
air.
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures Use in semi-closed process with opportunity for exposure

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with specific activity training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 95 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 58(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

4.2.6 ES 4 - CS 6: Control of worker exposure: Industrial use (Roller application or


brushing) (PROC10)

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 10 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Roller, spreader, flow application : > 3 m²/h

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with specific activity training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 95 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

4.2.7 ES 4 - CS 7: Control of worker exposure: Industrial use (Treatment of articles


by dipping and pouring) (PROC13)

Product characteristics
Concentration of the Substance in : >= 5 - <= 25 %
Mixture/Article ECETOC TRA worker V3
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 59(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Concentration of the Substance in : <= 10 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 4h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Handling of contaminated objects : > 3 m2, Activities with open liquid surfaces or open reservoirs
- activity with agitated surfaces, ART

Risk Management Measures


Organisational measures to : Advanced (industrial) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Advanced (industrial) exposure controls assumed.
measures

Exposure routes : inhalative


Technical conditions and : Local exhaust ventilation
measures
Effectiveness (of a measure) : >= 50 %

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with ‘basic’ employee training.
Use suitable eye protection.
Effectiveness (of a measure) : >= 90 %

Note : Moderate hazard


Risk management measures are based on qualitative risk
characterisation.

4.3. ES 4 Exposure estimation and reference to its source


4.3.1 ES 4 - CS 1: Environmental release and exposure: Industrial use (Use of non-
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 60(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

reactive processing aid at industrial site (no inclusion into or onto article)) (ERC4)

Release route Release rate Release estimation method


Water 0,41 kg/day EUSES v2.1
Air 0 kg/day EUSES v2.1
Soil 0 kg/day EUSES v2.1

Protection target Exposure estimation and reference to its source RCR


(based on EUSES v2.1)
Freshwater 0,000616 mg/L 0,154
Freshwater sediment 0,745 mg/kg dry weight 0,154
Marine water 0,0000598 mg/L 0,15
Marine sediment 0,0723 mg/kg dry weight 0,15
Sewage treatment plant. 0,00205 mg/L 0,0108
Indirect exposure to humans 0,0000332 mg/kg bw/day < 0,01
via the environment
Soil 0,0991 mg/kg dry weight 0,163

4.3.2 ES 4 - CS 2: Worker exposure: Industrial use (Chemical production or refinery


in closed process without likelihood of exposure or processes with equivalent
containment conditions) (PROC1)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,0046 mg/m³ (ART, Tier 2) < 0,01
- systemic
Worker - inhalative, long-term 0,0046 mg/m³ (ART, Tier 2) < 0,01
- local
Worker - inhalative, short-term 0,0092 mg/m³ (ART, Tier 2) < 0,01
- local
Worker - dermal, long-term - 0,001 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) < 0,01
systemic
Worker - combined, long-term < 0,01
- systemic

4.3.3 ES 4 - CS 3: Worker exposure: Industrial use (Manufacture or formulation in the


chemical industry in closed batch processes with occasional controlled exposure or
processes with equivalent containment condition) (PROC3)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,0052 mg/m³ (ART, Tier 2) < 0,01
- systemic
Worker - inhalative, long-term 0,0052 mg/m³ (ART, Tier 2) < 0,01
- local
Worker - inhalative, short-term 0,042 mg/m³ (ART, Tier 2) 0,042
- local
Worker - dermal, long-term - 0,017 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,013
systemic
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 61(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Worker - combined, long-term 0,016


- systemic

4.3.4 ES 4 - CS 4: Worker exposure: Industrial use (Mixing or blending in batch


processes) (PROC5)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,17 mg/m³ (ART, Tier 2) 0,077
- systemic
Worker - inhalative, long-term 0,17 mg/m³ (ART, Tier 2) 0,17
- local
Worker - inhalative, short-term 0,34 mg/m³ (ART, Tier 2) 0,34
- local
Worker - dermal, long-term - 0,411 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,329
systemic
Worker - combined, long-term 0,406
- systemic

4.3.5 ES 4 - CS 5: Worker exposure: Industrial use (Transfer of substance or mixture


(charging/discharging) at dedicated facilities) (PROC8b)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,052 mg/m³ (ART, Tier 2) 0,024
- systemic
Worker - inhalative, long-term 0,052 mg/m³ (ART, Tier 2) 0,052
- local
Worker - inhalative, short-term 0,41 mg/m³ (ART, Tier 2) 0,41
- local
Worker - dermal, long-term - 0,082 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,066
systemic
Worker - combined, long-term 0,089
- systemic

4.3.6 ES 4 - CS 6: Worker exposure: Industrial use (Roller application or brushing)


(PROC10)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,46 mg/m³ (ART, Tier 2) 0,209
- systemic
Worker - inhalative, long-term 0,46 mg/m³ (ART, Tier 2) 0,46
- local
Worker - inhalative, short-term 0,92 mg/m³ (ART, Tier 2) 0,92
- local
Worker - dermal, long-term - 0,823 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,658
systemic
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 62(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Worker - combined, long-term 0,867


- systemic

4.3.7 ES 4 - CS 7: Worker exposure: Industrial use (Treatment of articles by dipping


and pouring) (PROC13)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,34 mg/m³ (ART, Tier 2) 0,154
- systemic
Worker - inhalative, long-term 0,34 mg/m³ (ART, Tier 2) 0,34
- local
Worker - inhalative, short-term 0,68 mg/m³ (ART, Tier 2) 0,68
- local
Worker - dermal, long-term - 0,494 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,395
systemic
Worker - combined, long-term 0,549
- systemic

4.4. ES 4 Guidance to Downstream User to evaluate whether he


works inside the boundaries set by the Exposure Scenario
ECHA guidance for downstream users
Section 2

5. ES 5: Professional use; Washing and cleaning products,


Solid
5.1. Titles of Contributing scenarios (CS)

Environment
CS1: Professional use (Widespread use of non-reactive processing aid (no ERC8a
inclusion into or onto article, indoor))
Workers
CS2: Professional use (Manufacture or formulation in the chemical industry in PROC3
closed batch processes with occasional controlled exposure or
processes with equivalent containment condition)
CS3: Professional use (Mixing or blending in batch processes) PROC5
CS4: Professional use (Transfer of substance or mixture PROC8a
(charging/discharging) at non dedicated-facilities)
CS5: Professional use (Transfer of substance or mixture PROC8b
(charging/discharging) at dedicated facilities)
CS6: Professional use (Transfer of substance or mixture into small containers PROC9
(dedicated filling line, including weighing))
CS7: Professional use (Roller application or brushing) PROC10
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 63(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

CS8: Professional use (Treatment of articles by dipping and pouring) PROC13

5.2. ES 5 Conditions of use affecting exposure


5.2.1 ES 5 - CS 1: Control of environmental exposure: Professional use (Widespread
use of non-reactive processing aid (no inclusion into or onto article, indoor)) (ERC8a)

Amount used
Amounts used : 2700 tonnes/year
Remarks : Professional use, Consumer use
Amounts used : 2200 tonnes/year
Remarks : Professional use

Frequency and duration of use


Continuous exposure : 300 days per year

Environment factors not influenced by risk management


Flow rate of receiving surface : 18.000 m3/d
water

Conditions and measures related to sewage treatment plant


Type of Sewage Treatment Plant : Municipal Sewage Treatment Plant
Flow rate of sewage treatment : 2.000 m3/d
plant effluent
Effectiveness (of a measure) : 99 %

Waste management measures


Disposal methods : Dispose of waste product or used containers according to
local regulations.

5.2.2 ES 5 - CS 2: Control of worker exposure: Professional use (Manufacture or


formulation in the chemical industry in closed batch processes with occasional
controlled exposure or processes with equivalent containment condition) (PROC3)

Remarks : Sampling

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article

Physical Form (at time of use) : Solid, low dustiness


Remarks : Covers use at ambient temperatures., Covers solid products
only.

Frequency and duration of use


Exposure duration : 8h

Human factors not influenced by risk management


Dermal exposure : Palm of one hand
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 64(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Covers skin contact area up to : 240 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use

Risk Management Measures


Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Basic (professional) exposure controls assumed.
measures Manufacture or formulation in the chemical industry in closed
batch processes with occasional controlled exposure or
processes with equivalent containment condition
Provide a basic standard of general ventilation (1 to 3 air
changes per hour).
Note : Low hazard
Risk management measures are based on qualitative risk
characterisation.

5.2.3 ES 5 - CS 3: Control of worker exposure: Professional use (Mixing or blending


in batch processes) (PROC5)

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article

Physical Form (at time of use) : Solid, low dustiness


Remarks : Covers use at ambient temperatures., Covers solid products
only.

Frequency and duration of use


Exposure duration : 8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use

Risk Management Measures


Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Basic (professional) exposure controls assumed.
measures Provide a basic standard of general ventilation (1 to 3 air
changes per hour).

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with ‘basic’ employee training.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 65(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Effectiveness (of a measure) : >= 90 %

Note : Low hazard


Risk management measures are based on qualitative risk
characterisation.

5.2.4 ES 5 - CS 4: Control of worker exposure: Professional use (Transfer of


substance or mixture (charging/discharging) at non dedicated-facilities) (PROC8a)

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article

Physical Form (at time of use) : Solid, low dustiness


Remarks : Covers use at ambient temperatures., Covers solid products
only.

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use

Risk Management Measures


Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Basic (professional) exposure controls assumed.
measures Provide a basic standard of general ventilation (1 to 3 air
changes per hour).

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Effectiveness (of a measure) : >= 80 %

Note : Low hazard


Risk management measures are based on qualitative risk
characterisation.

5.2.5 ES 5 - CS 5: Control of worker exposure: Professional use (Transfer of


substance or mixture (charging/discharging) at dedicated facilities) (PROC8b)

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article

Physical Form (at time of use) : Solid, low dustiness


Remarks : Covers use at ambient temperatures., Covers solid products
only.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 66(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use

Risk Management Measures


Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Basic (professional) exposure controls assumed.
measures Provide a basic standard of general ventilation (1 to 3 air
changes per hour).
Use in semi-closed process with opportunity for exposure

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Effectiveness (of a measure) : >= 80 %

Note : Low hazard


Risk management measures are based on qualitative risk
characterisation.

5.2.6 ES 5 - CS 6: Control of worker exposure: Professional use (Transfer of


substance or mixture into small containers (dedicated filling line, including weighing))
(PROC9)

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article

Physical Form (at time of use) : Solid, low dustiness


Remarks : Covers use at ambient temperatures., Covers solid products
only.

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use

Risk Management Measures


SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 67(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Organisational measures to : Basic (professional) exposure controls assumed.


prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Basic (professional) exposure controls assumed.
measures Provide a basic standard of general ventilation (1 to 3 air
changes per hour).
Use in semi-closed process with opportunity for exposure

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Effectiveness (of a measure) : >= 80 %

Note : Low hazard


Risk management measures are based on qualitative risk
characterisation.

5.2.7 ES 5 - CS 7: Control of worker exposure: Professional use (Roller application or


brushing) (PROC10)

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 5 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Roller, spreader, flow application : > 3 m²/h

Risk Management Measures


Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Basic (professional) exposure controls assumed.
measures

Exposure routes : Dermal


SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 68(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Personal protective measures : Wear chemically resistant gloves (tested to EN374) in


combination with ‘basic’ employee training.
Effectiveness (of a measure) : >= 90 %

Note : Low hazard


Risk management measures are based on qualitative risk
characterisation.

5.2.8 ES 5 - CS 8: Control of worker exposure: Professional use (Treatment of


articles by dipping and pouring) (PROC13)

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 5 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Handling of contaminated objects : > 3 m2, Activities with open liquid surfaces or open reservoirs
- activity with agitated surfaces, ART

Risk Management Measures


Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Basic (professional) exposure controls assumed.
measures

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Effectiveness (of a measure) : >= 80 %

Note : Low hazard


Risk management measures are based on qualitative risk
characterisation.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 69(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

5.3. ES 5 Exposure estimation and reference to its source


5.3.1 ES 5 - CS 1: Environmental release and exposure: Professional use
(Widespread use of non-reactive processing aid (no inclusion into or onto article,
indoor)) (ERC8a)

Release route Release rate Release estimation method


Water 0,37 kg/day EUSES v2.1
Air 0 kg/day EUSES v2.1
Soil 0 kg/day EUSES v2.1

Protection target Exposure estimation and reference to its source RCR


(based on EUSES v2.1)
Freshwater 0,000596 mg/L 0,149
Freshwater sediment 0,721 mg/kg dry weight 0,149
Marine water 0,0000578 mg/L 0,145
Marine sediment 0,0699 mg/kg dry weight 0,145
Sewage treatment plant. 0,00185 mg/L < 0,01
Indirect exposure to humans 0,0000365 mg/kg bw/day < 0,01
via the environment
Soil 0,0894 mg/kg dry weight 0,147

5.3.2 ES 5 - CS 2: Worker exposure: Professional use (Manufacture or formulation in


the chemical industry in closed batch processes with occasional controlled exposure
or processes with equivalent containment condition) (PROC3)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,02 mg/m³ (ECETOC TRA worker V3, Tier 1) < 0,01
- systemic
Worker - inhalative, long-term 0,02 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,02
- local
Worker - inhalative, short-term 0,08 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,08
- local
Worker - dermal, long-term - 0,138 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,11
systemic
Worker - combined, long-term 0,12
- systemic

5.3.3 ES 5 - CS 3: Worker exposure: Professional use (Mixing or blending in batch


processes) (PROC5)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,2 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,091
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 70(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

- systemic
Worker - inhalative, long-term 0,2 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,2
- local
Worker - inhalative, short-term 0,8 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,8
- local
Worker - dermal, long-term - 0,274 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,219
systemic
Worker - combined, long-term 0,31
- systemic

5.3.4 ES 5 - CS 4: Worker exposure: Professional use (Transfer of substance or


mixture (charging/discharging) at non dedicated-facilities) (PROC8a)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,02 mg/m³ (ECETOC TRA worker V3, Tier 1) < 0,01
- systemic
Worker - inhalative, long-term 0,02 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,02
- local
Worker - inhalative, short-term 0,4 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,4
- local
Worker - dermal, long-term - 0,11 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,088
systemic
Worker - combined, long-term 0,097
- systemic

5.3.5 ES 5 - CS 5: Worker exposure: Professional use (Transfer of substance or


mixture (charging/discharging) at dedicated facilities) (PROC8b)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,02 mg/m³ (ECETOC TRA worker V3, Tier 1) < 0,01
- systemic
Worker - inhalative, long-term 0,02 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,02
- local
Worker - inhalative, short-term 0,4 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,4
- local
Worker - dermal, long-term - 0,11 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,088
systemic
Worker - combined, long-term 0,097
- systemic

5.3.6 ES 5 - CS 6: Worker exposure: Professional use (Transfer of substance or


mixture into small containers (dedicated filling line, including weighing)) (PROC9)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,02 mg/m³ (ECETOC TRA worker V3, Tier 1) < 0,01
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 71(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

- systemic
Worker - inhalative, long-term 0,02 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,02
- local
Worker - inhalative, short-term 0,4 mg/m³ (ECETOC TRA worker V3, Tier 1) 0,4
- local
Worker - dermal, long-term - 0,055 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,044
systemic
Worker - combined, long-term 0,053
- systemic

5.3.7 ES 5 - CS 7: Worker exposure: Professional use (Roller application or brushing)


(PROC10)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,23 mg/m³ (ART, Tier 2) 0,105
- systemic
Worker - inhalative, long-term 0,23 mg/m³ (ART, Tier 2) 0,23
- local
Worker - inhalative, short-term 0,46 mg/m³ (ART, Tier 2) 0,46
- local
Worker - dermal, long-term - 0,549 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,439
systemic
Worker - combined, long-term 0,543
- systemic

5.3.8 ES 5 - CS 8: Worker exposure: Professional use (Treatment of articles by


dipping and pouring) (PROC13)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,086 mg/m³ (ART, Tier 2) 0,039
- systemic
Worker - inhalative, long-term 0,086 mg/m³ (ART, Tier 2) 0,086
- local
Worker - inhalative, short-term 0,68 mg/m³ (ART, Tier 2) 0,68
- local
Worker - dermal, long-term - 0,11 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,088
systemic
Worker - combined, long-term 0,127
- systemic

5.4. ES 5 Guidance to Downstream User to evaluate whether he


works inside the boundaries set by the Exposure Scenario
ECHA guidance for downstream users
Section 2
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 72(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

6. ES 6: Professional use; Washing and cleaning products,


Liquid
6.1. Titles of Contributing scenarios (CS)

Environment
CS1: Professional use (Widespread use of non-reactive processing aid (no ERC8a
inclusion into or onto article, indoor))
Workers
CS2: Professional use (Chemical production or refinery in closed process PROC1
without likelihood of exposure or processes with equivalent containment
conditions)
CS3: Professional use (Manufacture or formulation in the chemical industry in PROC3
closed batch processes with occasional controlled exposure or
processes with equivalent containment condition)
CS4: Professional use (Mixing or blending in batch processes) PROC5
CS5: Professional use (Transfer of substance or mixture PROC8a
(charging/discharging) at non dedicated-facilities)
CS6: Professional use (Transfer of substance or mixture PROC8b
(charging/discharging) at dedicated facilities)
CS7: Professional use (Transfer of substance or mixture into small containers PROC9
(dedicated filling line, including weighing))
CS8: Professional use (Roller application or brushing) PROC10
CS9: Professional use (Treatment of articles by dipping and pouring) PROC13

6.2. ES 6 Conditions of use affecting exposure


6.2.1 ES 6 - CS 1: Control of environmental exposure: Professional use (Widespread
use of non-reactive processing aid (no inclusion into or onto article, indoor)) (ERC8a)

Amount used
Amounts used : 2700 tonnes/year
Remarks : Professional use, Consumer use
Amounts used : 2200 tonnes/year
Remarks : Professional use

Frequency and duration of use


Continuous exposure : 300 days per year

Environment factors not influenced by risk management


Flow rate of receiving surface : 18.000 m3/d
water

Conditions and measures related to sewage treatment plant


SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 73(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Type of Sewage Treatment Plant : Municipal Sewage Treatment Plant


Flow rate of sewage treatment : 2.000 m3/d
plant effluent
Effectiveness (of a measure) : 99 %

Waste management measures


Disposal methods : Dispose of waste product or used containers according to
local regulations.

6.2.2 ES 6 - CS 2: Control of worker exposure: Professional use (Chemical


production or refinery in closed process without likelihood of exposure or processes
with equivalent containment conditions) (PROC1)

Remarks : Spraying
Closed systems

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 5 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Palm of one hand
Covers skin contact area up to : 240 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Handling of contaminated objects : > 3 m2

Contamination : > 90 %, ART

Risk Management Measures


Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Basic (professional) exposure controls assumed.
measures Chemical production or refinery in closed process without
likelihood of exposure or processes with equivalent
containment conditions
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 74(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with ‘basic’ employee training.
Effectiveness (of a measure) : >= 90 %

Note : Low hazard


Risk management measures are based on qualitative risk
characterisation.

6.2.3 ES 6 - CS 3: Control of worker exposure: Professional use (Manufacture or


formulation in the chemical industry in closed batch processes with occasional
controlled exposure or processes with equivalent containment condition) (PROC3)

Remarks : Sampling

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 5 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Palm of one hand
Covers skin contact area up to : 240 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Transfer of liquid products - falling : 1 - 10 L/min, ART


liquids

Risk Management Measures


Type of Application (Use) : Splash loading
Open systems
Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Basic (professional) exposure controls assumed.
measures Manufacture or formulation in the chemical industry in closed
batch processes with occasional controlled exposure or
processes with equivalent containment condition
Note : Low hazard
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 75(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Risk management measures are based on qualitative risk


characterisation.

6.2.4 ES 6 - CS 4: Control of worker exposure: Professional use (Mixing or blending


in batch processes) (PROC5)

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 5 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Handling of contaminated objects : 1 - 3 m2, Activities with open liquid surfaces or open
reservoirs - activity with agitated surfaces, ART

Risk Management Measures


Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Ensure that the distance from worker to task is greater than 1
m.
Technical conditions and : Basic (professional) exposure controls assumed.
measures

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with ‘basic’ employee training.
Effectiveness (of a measure) : >= 90 %

Note : Low hazard


Risk management measures are based on qualitative risk
characterisation.

6.2.5 ES 6 - CS 5: Control of worker exposure: Professional use (Transfer of


SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 76(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

substance or mixture (charging/discharging) at non dedicated-facilities) (PROC8a)

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 5 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Transfer of liquid products - falling : > 1000 L/min, ART


liquids

Risk Management Measures


Type of Application (Use) : Splash loading
Open systems
Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Basic (professional) exposure controls assumed.
measures

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Effectiveness (of a measure) : >= 80 %

Note : Low hazard


Risk management measures are based on qualitative risk
characterisation.

6.2.6 ES 6 - CS 6: Control of worker exposure: Professional use (Transfer of


substance or mixture (charging/discharging) at dedicated facilities) (PROC8b)

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article ECETOC TRA worker V3
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 77(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Concentration of the Substance in : <= 5 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Transfer of liquid products - falling : > 1000 L/min, ART


liquids

Risk Management Measures


Type of Application (Use) : Splash loading
Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Handling that reduces contact between product and adjacent
air.
Technical conditions and : Basic (professional) exposure controls assumed.
measures Use in semi-closed process with opportunity for exposure

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Effectiveness (of a measure) : >= 80 %

Note : Low hazard


Risk management measures are based on qualitative risk
characterisation.

6.2.7 ES 6 - CS 7: Control of worker exposure: Professional use (Transfer of


substance or mixture into small containers (dedicated filling line, including weighing))
(PROC9)

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 5 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 78(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Remarks : Substances in preparations / mixtures


Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Transfer of liquid products - falling : 100 - 1000 L/min, ART


liquids

Risk Management Measures


Type of Application (Use) : Splash loading
Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Handling that reduces contact between product and adjacent
air.
Technical conditions and : Basic (professional) exposure controls assumed.
measures Use in semi-closed process with opportunity for exposure

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Effectiveness (of a measure) : >= 80 %

Note : Low hazard


Risk management measures are based on qualitative risk
characterisation.

6.2.8 ES 6 - CS 8: Control of worker exposure: Professional use (Roller application or


brushing) (PROC10)

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 5 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 79(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Frequency and duration of use


Exposure duration : 8h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to hands.
Covers skin contact area up to : 960 cm²

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Roller, spreader, flow application : > 3 m²/h

Risk Management Measures


Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Basic (professional) exposure controls assumed.
measures

Exposure routes : Dermal


Personal protective measures : Wear chemically resistant gloves (tested to EN374) in
combination with ‘basic’ employee training.
Effectiveness (of a measure) : >= 90 %

Note : Low hazard


Risk management measures are based on qualitative risk
characterisation.

6.2.9 ES 6 - CS 9: Control of worker exposure: Professional use (Treatment of


articles by dipping and pouring) (PROC13)

Product characteristics
Concentration of the Substance in : >= 1 - <= 5 %
Mixture/Article ECETOC TRA worker V3

Concentration of the Substance in : <= 5 %


Mixture/Article ART

Physical Form (at time of use) : Liquid, Low viscosity


Remarks : Substances in preparations / mixtures
Physical Form (at time of use) : Solid, Powder products
Remarks : Covers solid products only.

Frequency and duration of use


Exposure duration : 1h

Human factors not influenced by risk management


Dermal exposure : Assumes that potential dermal contact is limited to inside
hands / one hand / palm of hands.
Covers skin contact area up to : 480 cm²
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 80(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Other operational conditions affecting workers exposure


Outdoor / Indoor : Indoor use
Room size : 300 m3
Ventilation rate per hour : 1

Handling of contaminated objects : > 3 m2, Activities with open liquid surfaces or open reservoirs
- activity with agitated surfaces, ART

Risk Management Measures


Organisational measures to : Basic (professional) exposure controls assumed.
prevent /limit releases, dispersion Assumes a good basic standard of occupational hygiene is
and exposure implemented
Technical conditions and : Basic (professional) exposure controls assumed.
measures

Exposure routes : Dermal


Personal protective measures : Wear suitable gloves tested to EN374.
Effectiveness (of a measure) : >= 80 %

Note : Low hazard


Risk management measures are based on qualitative risk
characterisation.

6.3. ES 6 Exposure estimation and reference to its source


6.3.1 ES 6 - CS 1: Environmental release and exposure: Professional use
(Widespread use of non-reactive processing aid (no inclusion into or onto article,
indoor)) (ERC8a)

Release route Release rate Release estimation method


Water 0,37 kg/day EUSES v2.1
Air 0 kg/day EUSES v2.1
Soil 0 kg/day EUSES v2.1

Protection target Exposure estimation and reference to its source RCR


(based on EUSES v2.1)
Freshwater 0,000596 mg/L 0,149
Freshwater sediment 0,721 mg/kg dry weight 0,149
Marine water 0,0000578 mg/L 0,145
Marine sediment 0,0699 mg/kg dry weight 0,145
Sewage treatment plant. 0,00185 mg/L < 0,01
Indirect exposure to humans 0,0000365 mg/kg bw/day < 0,01
via the environment
Soil 0,0894 mg/kg dry weight 0,147

6.3.2 ES 6 - CS 2: Worker exposure: Professional use (Chemical production or


refinery in closed process without likelihood of exposure or processes with
equivalent containment conditions) (PROC1)
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 81(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,00029 mg/m³ (ART, Tier 2) < 0,01
- systemic
Worker - inhalative, long-term 0,00029 mg/m³ (ART, Tier 2) < 0,01
- local
Worker - inhalative, short-term 0,0023 mg/m³ (ART, Tier 2) < 0,01
- local
Worker - dermal, long-term - 0,000136 mg/kg bw/day (ECETOC TRA worker V3, Tier < 0,01
systemic 1)
Worker - combined, long-term < 0,01
- systemic

6.3.3 ES 6 - CS 3: Worker exposure: Professional use (Manufacture or formulation in


the chemical industry in closed batch processes with occasional controlled exposure
or processes with equivalent containment condition) (PROC3)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,0026 mg/m³ (ART, Tier 2) < 0,01
- systemic
Worker - inhalative, long-term 0,0026 mg/m³ (ART, Tier 2) < 0,01
- local
Worker - inhalative, short-term 0,021 mg/m³ (ART, Tier 2) 0,021
- local
Worker - dermal, long-term - 0,028 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,022
systemic
Worker - combined, long-term 0,023
- systemic

6.3.4 ES 6 - CS 4: Worker exposure: Professional use (Mixing or blending in batch


processes) (PROC5)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,25 mg/m³ (ART, Tier 2) 0,114
- systemic
Worker - inhalative, long-term 0,25 mg/m³ (ART, Tier 2) 0,25
- local
Worker - inhalative, short-term 0,5 mg/m³ (ART, Tier 2) 0,5
- local
Worker - dermal, long-term - 0,274 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,219
systemic
Worker - combined, long-term 0,333
- systemic

6.3.5 ES 6 - CS 5: Worker exposure: Professional use (Transfer of substance or


SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 82(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

mixture (charging/discharging) at non dedicated-facilities) (PROC8a)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,086 mg/m³ (ART, Tier 2) 0,039
- systemic
Worker - inhalative, long-term 0,086 mg/m³ (ART, Tier 2) 0,086
- local
Worker - inhalative, short-term 0,68 mg/m³ (ART, Tier 2) 0,68
- local
Worker - dermal, long-term - 0,11 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,088
systemic
Worker - combined, long-term 0,127
- systemic

6.3.6 ES 6 - CS 6: Worker exposure: Professional use (Transfer of substance or


mixture (charging/discharging) at dedicated facilities) (PROC8b)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,026 mg/m³ (ART, Tier 2) 0,012
- systemic
Worker - inhalative, long-term 0,026 mg/m³ (ART, Tier 2) 0,026
- local
Worker - inhalative, short-term 0,21 mg/m³ (ART, Tier 2) 0,21
- local
Worker - dermal, long-term - 0,11 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,088
systemic
Worker - combined, long-term 0,1
- systemic

6.3.7 ES 6 - CS 7: Worker exposure: Professional use (Transfer of substance or


mixture into small containers (dedicated filling line, including weighing)) (PROC9)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,0078 mg/m³ (ART, Tier 2) < 0,01
- systemic
Worker - inhalative, long-term 0,0078 mg/m³ (ART, Tier 2) < 0,01
- local
Worker - inhalative, short-term 0,062 mg/m³ (ART, Tier 2) 0,062
- local
Worker - dermal, long-term - 0,055 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,044
systemic
Worker - combined, long-term 0,047
- systemic

6.3.8 ES 6 - CS 8: Worker exposure: Professional use (Roller application or brushing)


SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 83(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

(PROC10)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,23 mg/m³ (ART, Tier 2) 0,105
- systemic
Worker - inhalative, long-term 0,23 mg/m³ (ART, Tier 2) 0,23
- local
Worker - inhalative, short-term 0,46 mg/m³ (ART, Tier 2) 0,46
- local
Worker - dermal, long-term - 0,549 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,439
systemic
Worker - combined, long-term 0,543
- systemic

6.3.9 ES 6 - CS 9: Worker exposure: Professional use (Treatment of articles by


dipping and pouring) (PROC13)

Route of exposure and type Exposure estimate RCR


of effects
Worker - inhalative, long-term 0,086 mg/m³ (ART, Tier 2) 0,039
- systemic
Worker - inhalative, long-term 0,086 mg/m³ (ART, Tier 2) 0,086
- local
Worker - inhalative, short-term 0,68 mg/m³ (ART, Tier 2) 0,68
- local
Worker - dermal, long-term - 0,11 mg/kg bw/day (ECETOC TRA worker V3, Tier 1) 0,088
systemic
Worker - combined, long-term 0,127
- systemic

6.4. ES 6 Guidance to Downstream User to evaluate whether he


works inside the boundaries set by the Exposure Scenario
ECHA guidance for downstream users
Section 2

7. ES 7: Consumer use; Washing and cleaning products,


Liquid
7.1. Titles of Contributing scenarios (CS)

Washing and cleaning products (PC35)


Environment
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 84(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

CS1: Consumer use (Widespread use of non-reactive processing aid (no ERC8a
inclusion into or onto article, indoor))
Consumer
CS2: Consumer use (Washing and cleaning products) PC35
CS3: Consumer use (Washing and cleaning products) PC35
CS4: Consumer use (Washing and cleaning products) PC35
CS5: Consumer use (Washing and cleaning products) PC35
CS6: Consumer use (Washing and cleaning products) PC35

7.2. ES 7 Conditions of use affecting exposure

7.2.1 ES 7 - CS 1: Control of environmental exposure: Consumer use (Widespread


use of non-reactive processing aid (no inclusion into or onto article, indoor)) (ERC8a)

Amount used
Amounts used : 2700 tonnes/year
Remarks : Professional use, Consumer use
Amounts used : 500 tonnes/year
Remarks : Consumer use

Frequency and duration of use


Continuous exposure : 365 days per year

Environment factors not influenced by risk management


Flow rate of receiving surface : 18.000 m3/d
water

Conditions and measures related to sewage treatment plant


Type of Sewage Treatment Plant : Municipal Sewage Treatment Plant
Flow rate of sewage treatment : 2.000 m3/d
plant effluent
Effectiveness (of a measure) : 99 %

Waste management measures


Disposal methods : Dispose of waste product or used containers according to
local regulations.

7.2.2 ES 7 - CS 2: Control of consumer exposure: Consumer use (Washing and


cleaning products) (PC35)

Remarks : Laundry and dish washing products


Manual

Product characteristics
Concentration of the Substance in : <= 2 %
Mixture/Article Concentration of substance in product

Concentration of the Substance in : <= 0,02 %


SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 85(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Mixture/Article Concentration after dilution for use maximum, AISE REACT

Physical Form (at time of use) : Liquid

Frequency and duration of use


Frequency of use : 1,4 uses per day
Remarks : AISE REACT

Human factors not influenced by risk management


Covers skin contact area up to : 2082 cm²

Conditions and measures related to protection of consumer (e.g. behavioural advice,


personal protection and hygiene)
Consumer Measures : Ensure that splashes and spills are avoided by product
design.
Consumer Measures : Ensure that direct skin contact is avoided.

7.2.3 ES 7 - CS 3: Control of consumer exposure: Consumer use (Washing and


cleaning products) (PC35)

Remarks : Laundry and dish washing products


Textile pretreatment

Product characteristics
Concentration of the Substance in : <= 2 %
Mixture/Article

Physical Form (at time of use) : Liquid

Frequency and duration of use


Frequency of use : 0,5 uses per day
Remarks : AISE REACT

Human factors not influenced by risk management


Covers skin contact area up to : 857,5 cm²

Conditions and measures related to protection of consumer (e.g. behavioural advice,


personal protection and hygiene)
Consumer Measures : Ensure that splashes and spills are avoided by product
design.
Consumer Measures : Ensure that direct skin contact is avoided.

7.2.4 ES 7 - CS 4: Control of consumer exposure: Consumer use (Washing and


cleaning products) (PC35)

Remarks : Laundry and dish washing products


Clothing (all kind of materials), towel

Product characteristics
Concentration of the Substance in : <= 2 %
Mixture/Article
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 86(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Physical Form (at time of use) : Liquid

Amount used
Amounts used : 230 grams

Human factors not influenced by risk management


Covers skin contact area up to : 14320 cm²

Conditions and measures related to protection of consumer (e.g. behavioural advice,


personal protection and hygiene)
Consumer Measures : Ensure that splashes and spills are avoided by product
design.
Consumer Measures : Ensure that direct skin contact is avoided.

7.2.5 ES 7 - CS 5: Control of consumer exposure: Consumer use (Washing and


cleaning products) (PC35)

Remarks : Hand dishwasing (liquid regular, liquid concentrate) for


consumer use

Product characteristics
Concentration of the Substance in : <= 2 %
Mixture/Article

Physical Form (at time of use) : Liquid

Conditions and measures related to protection of consumer (e.g. behavioural advice,


personal protection and hygiene)
Consumer Measures : Ensure that splashes and spills are avoided by product
design.
Consumer Measures : Ensure that direct skin contact is avoided.

7.2.6 ES 7 - CS 6: Control of consumer exposure: Consumer use (Washing and


cleaning products) (PC35)

Remarks : Machine dishwashing (powder, liquid, tablet) for consumer


use

Product characteristics
Concentration of the Substance in : <= 2 %
Mixture/Article

Physical Form (at time of use) : Liquid

Conditions and measures related to protection of consumer (e.g. behavioural advice,


personal protection and hygiene)
Consumer Measures : Ensure that splashes and spills are avoided by product
design.
Consumer Measures : Ensure that direct skin contact is avoided.
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 87(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

7.3. ES 7 Exposure estimation and reference to its source


7.3.1 ES 7 - CS 1: Environmental release and exposure: Consumer use (Widespread
use of non-reactive processing aid (no inclusion into or onto article, indoor)) (ERC8a)

Release route Release rate Release estimation method


Water 0,37 kg/day EUSES v2.1
Air 0 kg/day EUSES v2.1
Soil 0 kg/day EUSES v2.1

Protection target Exposure estimation and reference to its source RCR


(based on EUSES v2.1)
Freshwater 0,000596 mg/L 0,149
Freshwater sediment 0,721 mg/kg dry weight 0,149
Marine water 0,0000578 mg/L 0,145
Marine sediment 0,0699 mg/kg dry weight 0,145
Sewage treatment plant. 0,00185 mg/L < 0,01
Indirect exposure to humans 0,0000365 mg/kg bw/day < 0,01
via the environment
Soil 0,0894 mg/kg dry weight 0,147

7.3.2 ES 7 - CS 2: Consumer exposure: Consumer use (Washing and cleaning


products) (PC35)

Route of exposure and type Exposure estimate RCR


of effects
Consumer - dermal, long-term 0,004 mg/kg bw/day (AISE REACT) < 0,01
- systemic
Consumer - combined, long- < 0,01
term - systemic

7.3.3 ES 7 - CS 3: Consumer exposure: Consumer use (Washing and cleaning


products) (PC35)

Route of exposure and type Exposure estimate RCR


of effects
Consumer - dermal, long-term 0,057 mg/kg bw/day (AISE REACT) 0,064
- systemic
Consumer - combined, long- 0,064
term - systemic

7.3.4 ES 7 - CS 4: Consumer exposure: Consumer use (Washing and cleaning


products) (PC35)
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 88(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Route of exposure and type Exposure estimate RCR


of effects
Consumer - dermal, long-term 0,0000188 mg/kg bw/day (AISE REACT) < 0,01
- systemic
Consumer - combined, long- < 0,01
term - systemic

7.3.5 ES 7 - CS 5: Consumer exposure: Consumer use (Washing and cleaning


products) (PC35)

Route of exposure and type Exposure estimate RCR


of effects
Consumer - dermal, long-term 0,000833 mg/kg bw/day (AISE REACT) < 0,01
- systemic
Consumer - oral, long-term - 0,000495 mg/kg bw/day (AISE REACT) < 0,01
systemic
Consumer - combined, long- < 0,01
term - systemic

7.3.6 ES 7 - CS 6: Consumer exposure: Consumer use (Washing and cleaning


products) (PC35)

Route of exposure and type Exposure estimate RCR


of effects
Consumer - oral, long-term - 0,000495 mg/kg bw/day (AISE REACT) < 0,01
systemic
Consumer - combined, long- < 0,01
term - systemic

7.4. ES 7 Guidance to Downstream User to evaluate whether he


works inside the boundaries set by the Exposure Scenario
ECHA guidance for downstream users
Section 2

8. ES 8: Consumer use; Washing and cleaning products,


Solid
8.1. Titles of Contributing scenarios (CS)

Washing and cleaning products (PC35)


Environment
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 89(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

CS1: Consumer use (Widespread use of non-reactive processing aid (no ERC8a
inclusion into or onto article, indoor))
Consumer
CS2: Consumer use (Washing and cleaning products) PC35
CS3: Consumer use (Washing and cleaning products) PC35
CS4: Consumer use (Washing and cleaning products) PC35

8.2. ES 8 Conditions of use affecting exposure

8.2.1 ES 8 - CS 1: Control of environmental exposure: Consumer use (Widespread


use of non-reactive processing aid (no inclusion into or onto article, indoor)) (ERC8a)

Amount used
Amounts used : 2700 tonnes/year
Remarks : Professional use, Consumer use
Amounts used : 500 tonnes/year
Remarks : Consumer use

Frequency and duration of use


Continuous exposure : 365 days per year

Environment factors not influenced by risk management


Flow rate of receiving surface : 18.000 m3/d
water

Conditions and measures related to sewage treatment plant


Type of Sewage Treatment Plant : Municipal Sewage Treatment Plant
Flow rate of sewage treatment : 2.000 m3/d
plant effluent
Effectiveness (of a measure) : 99 %

Waste management measures


Disposal methods : Dispose of waste product or used containers according to
local regulations.

8.2.2 ES 8 - CS 2: Control of consumer exposure: Consumer use (Washing and


cleaning products) (PC35)

Remarks : Laundry and dish washing products


Manual

Product characteristics
Concentration of the Substance in : <= 2 %
Mixture/Article Concentration of substance in product

Concentration of the Substance in : <= 0,02 %


Mixture/Article Concentration after dilution for use maximum, AISE REACT
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 90(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Physical Form (at time of use) : Powder products

Frequency and duration of use


Frequency of use : 2,6 uses per day
Remarks : AISE REACT

Human factors not influenced by risk management


Covers skin contact area up to : 2082 cm²

Conditions and measures related to protection of consumer (e.g. behavioural advice,


personal protection and hygiene)
Consumer Measures : Ensure that splashes and spills are avoided by product
design.
Consumer Measures : Ensure that direct skin contact is avoided.

8.2.3 ES 8 - CS 3: Control of consumer exposure: Consumer use (Washing and


cleaning products) (PC35)

Remarks : Laundry and dish washing products


Textile pretreatment

Product characteristics
Concentration of the Substance in : <= 2 %
Mixture/Article Concentration of substance in product

Concentration of the Substance in : <= 1,2 %


Mixture/Article Concentration after dilution for use maximum, AISE REACT

Physical Form (at time of use) : Powder products

Frequency and duration of use


Frequency of use : 0,5 uses per day
Remarks : AISE REACT

Human factors not influenced by risk management


Covers skin contact area up to : 857,5 cm²

Conditions and measures related to protection of consumer (e.g. behavioural advice,


personal protection and hygiene)
Consumer Measures : Ensure that splashes and spills are avoided by product
design.
Consumer Measures : Ensure that direct skin contact is avoided.

8.2.4 ES 8 - CS 4: Control of consumer exposure: Consumer use (Washing and


cleaning products) (PC35)

Remarks : Laundry and dish washing products


Clothing (all kind of materials), towel

Product characteristics
Concentration of the Substance in : <= 2 %
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 91(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

Mixture/Article

Physical Form (at time of use) : Powder products

Amount used
Amounts used : 290 grams

Human factors not influenced by risk management


Covers skin contact area up to : 14320 cm²

Conditions and measures related to protection of consumer (e.g. behavioural advice,


personal protection and hygiene)
Consumer Measures : Ensure that splashes and spills are avoided by product
design.
Consumer Measures : Ensure that direct skin contact is avoided.

8.3. ES 8 Exposure estimation and reference to its source


8.3.1 ES 8 - CS 1: Environmental release and exposure: Consumer use (Widespread
use of non-reactive processing aid (no inclusion into or onto article, indoor)) (ERC8a)

Release route Release rate Release estimation method


Water 0,37 kg/day EUSES v2.1
Air 0 kg/day EUSES v2.1
Soil 0 kg/day EUSES v2.1

Protection target Exposure estimation and reference to its source RCR


(based on EUSES v2.1)
Freshwater 0,000596 mg/L 0,149
Freshwater sediment 0,721 mg/kg dry weight 0,149
Marine water 0,0000578 mg/L 0,145
Marine sediment 0,0699 mg/kg dry weight 0,145
Sewage treatment plant. 0,00185 mg/L < 0,01
Indirect exposure to humans 0,0000365 mg/kg bw/day < 0,01
via the environment
Soil 0,0894 mg/kg dry weight 0,147

8.3.2 ES 8 - CS 2: Consumer exposure: Consumer use (Washing and cleaning


products) (PC35)

Route of exposure and type Exposure estimate RCR


of effects
Consumer - dermal, long-term 0,007 mg/kg bw/day (AISE REACT) < 0,01
- systemic
Consumer - combined, long- < 0,01
term - systemic
SAFETY DATA SHEET
according to Regulation (EC) No. 1907/2006

PRAEPAGEN HY Page 92(92)


Substance key: SXR004885 Revision Date: 22.09.2016
Version : 8 - 1 / EU Date of printing : 17.09.2018

8.3.3 ES 8 - CS 3: Consumer exposure: Consumer use (Washing and cleaning


products) (PC35)

Route of exposure and type Exposure estimate RCR


of effects
Consumer - dermal, long-term 0,034 mg/kg bw/day (AISE REACT) 0,038
- systemic
Consumer - combined, long- 0,038
term - systemic

8.3.4 ES 8 - CS 4: Consumer exposure: Consumer use (Washing and cleaning


products) (PC35)

Route of exposure and type Exposure estimate RCR


of effects
Consumer - dermal, long-term 0,0000237 mg/kg bw/day (AISE REACT) < 0,01
- systemic
Consumer - combined, long- < 0,01
term - systemic

8.4. ES 8 Guidance to Downstream User to evaluate whether he


works inside the boundaries set by the Exposure Scenario
ECHA guidance for downstream users
Section 2

You might also like