The Brief Profile summarizes the non-confidential data on substances as it is held in the databases of the European Chemicals Agency

(ECHA), including data provided by third parties. The Brief Profile is automatically generated; note that it
does not currently distinguish between harmonised classification and minimum classification; information requirements under different legislative frameworks may therefore not be fully up to date or complete. For accuracy reasons,
substance manufacturers and imports have the responsibility to consult official sources, e.g. the electronic edition of the Official Journal of the European Union.
This Brief Profile is covered by the ECHA Legal Notice.

Sodium 8-phenylamino-5-(4-(3-sulphonatophenylazo)-1-naphthylazo)naphthalenesulphonate

Brief Profile - Last updated: 01/11/2023

Substance Description

Substance identity

EC / List name: SMILES: [Na+].[Na+].[O-]S(=O)

IUPAC name: disodium 8-(phenylamino)-5-[(1E)-2-{4-
[(1E)-2-(3-sulfonatophenyl)diazen-1-yl]naphthalen-1-
yl}diazen-1-yl]naphthalene-1-sulfonate
Substance names and other identifiers
(=O)C1=CC(=CC=C1)\N=N\C1=CC=C(\N=N\C2=CC=C(NC3=CC
=CC=C3)C3=C2C=CC=C3S([O-])(=O)=O)C2=C1C=CC=C2
InChI: InChI=1S/C32H23N5O6S2.2Na/c38-44(39,40)23-11-6-10-
22(20-23)34-35-27-16-17-28(25-13-5-4-12-24(25)27)36-37-29-
18-19-30(33-21-8-2-1-3-9-21)32-26(29)14-7-15-
31(32)45(41,42)43;;/h1-20,33H,(H,38,39,40)
(H,41,42,43);;/q;2*+1/p-2/b35-34+,37-36+;;

Type of substance: Mono constituent substance

EC / List no.: 222-111-5
Origin: Organic
CAS no.: 3351-05-1
Registered compositions: 6
Index number:
Of which contain: 0 impurities relevant for classification
Molecular formula: C32H21N5Na2O6S2
0 additives relevant for classification

Substance Listed: EINECS (European INventory of Existing Commercial chemical

Substances) List

Hazard classification & labelling

Breakdown of all 294 C&L notifications submitted to ECHA

Eye Irrit. 2 H319

Aquatic Chronic 3 H412

Danger! According to the classification provided by companies to ECHA in REACH registrations
this substance causes serious eye irritation, is harmful to aquatic life with long lasting effects Skin Sens. 1 H317
and may cause an allergic skin reaction. Aquatic Chronic 2 H411

Not Classified

Skin Sens. 1B H317

Eye Dam. 1 H318

0% 10% 20% 30% 40% 50% 60% 70% 80% 90% 100%

Additionally, the classification provided by companies to ECHA in CLP notifications identifies

that this substance is toxic to aquatic life with long lasting effects.
Harmonised Classification
R E A C H re g i s t ra t i o n d o s s i e r s n o t i f i c a t i o n s
CLP notifications

Properties of concern

Ss There is broad agreement in that a majority of data submitters agree this substance is Skin sensitising (100% of REACH registrations).

Regulatory context

Registration, Evaluation, Authorisation & Restriction of Chemicals (REACH) Classification Labelling & Packaging (CLP)

Registration Harmonised C&L:

Pre-registration: Substance pre-registered under REACH.

Seveso Annex I:

Registration: This substance has 17 active registrations under REACH, 1

Notified C&L: Classification & Labelling has been notified by industry to ECHA
Joint Submission(s) and 0 Individual Submission(s).
for this substance.
Evaluation
Biocidal Products Regulation (BPR)
Dossier Evaluation:
Active Substance:
Substance Evaluation:
Biocidal Products:
Authorisation
Prior Informed Consent (PIC)
Candidate List:
Annex I:
Annex XIV (Authorisation List):

Restriction
Annex V:

Annex XVII (Restriction List): European Union Observatory for Nanomaterials (EUON)

Persistent Organic Pollutants Regulation (POPs) EUON:

List of substances subject to

the POPs Regulation:

List of substances proposed

as POPs:
About this substance

General
This substance is registered under the REACH Regulation and is manufactured in and / or imported to the European Economic Area, at ≥ 10 to < 100 tonnes per annum.

This substance is used by consumers, in articles, by professional workers (widespread uses), in formulation or re-packing, at industrial sites and in manufacturing.

Consumer Uses
This substance is used in the following products: textile treatment products and dyes, coating products, leather treatment products and paper chemicals and dyes.

Other release to the environment of this substance is likely to occur from: indoor use and outdoor use resulting in inclusion into or onto a materials (e.g. binding agent in paints and coatings or
adhesives).

Article service life

This substance is used in the following activities or processes at workplace: the low energy manipulation of substances bound in materials or articles and high energy work-up of substances
bound in materials or articles (e.g. hot rolling/forming, grinding, mechanical cutting, drilling or sanding).

Release to the environment of this substance can occur from industrial use: industrial abrasion processing with low release rate (e.g. cutting of textile, cutting, machining or grinding of metal).
Other release to the environment of this substance is likely to occur from: indoor use in long-life materials with low release rate (e.g. flooring, furniture, toys, construction materials, curtains, foot-
wear, leather products, paper and cardboard products, electronic equipment) and outdoor use in long-life materials with low release rate (e.g. metal, wooden and plastic construction and building
materials).

This substance can be found in products with material based on: paper (e.g. tissues, feminine hygiene products, nappies, books, magazines, wallpaper), fabrics, textiles and apparel (e.g. clothing,
mattress, curtains or carpets, textile toys) and leather (e.g. gloves, shoes, purses, furniture).

Widespread uses by professional workers

This substance is used in the following products: textile treatment products and dyes, coating products and leather treatment products.

This substance is used in the following areas: printing and recorded media reproduction. This substance is used for the manufacture of: textile, leather or fur.

This substance is used in the following activities or processes at workplace: treatment of articles by dipping and pouring, transfer of substance into small containers, calendering operations, non-
industrial spraying, transfer of chemicals, mixing in open batch processes, roller or brushing applications and the low energy manipulation of substances bound in materials or articles.

Other release to the environment of this substance is likely to occur from: indoor use (e.g. machine wash liquids/detergents, automotive care products, paints and coating or adhesives, fragrances
and air fresheners).

Formulation or re-packing
This substance is used in the following products: textile treatment products and dyes, leather treatment products, paper chemicals and dyes, inks and toners, polymers and coating products.

This substance is used in the following activities or processes at workplace: transfer of chemicals, mixing in open batch processes, transfer of substance into small containers, laboratory work,
batch processing in synthesis or formulation with opportunity for exposure, industrial spraying and treatment of articles by dipping and pouring.

Release to the environment of this substance can occur from industrial use: formulation of mixtures.

Uses at industrial sites

This substance is used in the following products: leather treatment products, paper chemicals and dyes, textile treatment products and dyes, inks and toners and polymers.

This substance is used in the following areas: printing and recorded media reproduction. This substance is used for the manufacture of: textile, leather or fur, pulp, paper and paper products, wood
and wood products and plastic products.

This substance is used in the following activities or processes at workplace: transfer of chemicals, transfer of substance into small containers, treatment of articles by dipping and pouring, roller
or brushing applications, mixing in open batch processes, calendering operations, industrial spraying, closed, continuous processes with occasional controlled exposure, the low energy
manipulation of substances bound in materials or articles, high energy work-up of substances bound in materials or articles (e.g. hot rolling/forming, grinding, mechanical cutting, drilling or
sanding), laboratory work and production of mixtures or articles by tabletting, compression, extrusion or pelletisation.

Release to the environment of this substance can occur from industrial use: in the production of articles and industrial abrasion processing with low release rate (e.g. cutting of textile, cutting,
machining or grinding of metal).

Manufacture
This substance is used in the following activities or processes at workplace: transfer of chemicals, closed batch processing in synthesis or formulation, batch processing in synthesis or
formulation with opportunity for exposure, transfer of substance into small containers and laboratory work.

Release to the environment of this substance can occur from industrial use: manufacturing of the substance.

Precautionary Measures and safe use

ECHA has no data from registration dossiers on the precautionary measures for using this substance. Guidance on the safe use of the substance provided by manufacturers and importers of this
substance.

Registrants/suppliers

Active
Archroma Germany GmbH, Kasteler Str. 45 65203 Wiesbaden Germany
ARCHROMA IBÉRICA, S.L., ZAL-Prat c/Cal Coracero, 46-56 08820 El Prat de Llobregat Spain
BIOKIMICA SPA, VIA DEI CONCIATORI, 44 56029 SANTA CROCE SULL'ARNO (PI) Italy
CODYECO SPA, Vicolo del Grano, 8 56029 Santa Croce sull'Arno - Pisa Toscana - Italy Italy
DyStar Colours Distribution GmbH, Am Prime-Parc 12 65479 Raunheim Germany
Farbchemie Braun GmbH & Co.KG, Daimlerring 11 65205 Wiesbaden Germany
Huntsman Textile Effects (Germany) GmbH, Rehlinger Str. 1 D-86462 Langweid a.Lech
Germany
NEOCOLOR S.R.L., Dell'Industria 28 21019 Somma Lombardo Varese Italy
Only representative (No publishable name), null
Reach & Colours s.r.o, Thunovská 196/19 Malá Strana 118 00 Prague Czech Republic
Reach & Colours Trade Kft, Levente u. 14/a 2161 Csomád Hungary
REACH&Colours Kft, Petofi Sandor utca 11 I Em. 4 1052 Budapest Hungary
Stahl Europe B.V., Sluisweg 10 5145PE Waalwijk Noord Brabant Netherlands
TEXTILCOLOR GmbH (OR), Schlossgartenstrasse 2 72793 Pfullingen Baden-Wuerttemberg
Germany
TFL Ledertechnik GmbH, Peter-Krauseneck-Strasse 16 79618 Rheinfelden Germany
Triade B.V., Dijkweg 159 2675 AD Honselersdijk Netherlands
TRUMPLER ESPAÑOLA, S.A., Llobateras, 15 08210 Barberà del Vallès Spain

Inactive
Substance names and other identifiers

Regulatory process names

Sodium 8-phenylamino-5-(4-(3- EC Inventory sodium 8-phenylamino-5-(4-(3- REACH pre-registration
sulphonatophenylazo)-1- sulphonatophenylazo)-1-
naphthylazo)naphthalenesulphonate naphthylazo)naphthalenesulphonate
Translated names

CAS names

IUPAC names
1-Naphthalenesulfonic acid, 8- Registration dossier disodium 8-(phenylamino)-5-[(E)-2- Registration dossier, Other
(phenylamino)-5-[2-[4-[2-(3- {4-[(E)-2-(3-sulfophenyl)diazen-1-
sulfophenyl)diazenyl]-1- yl]naphthalen-1-yl}diazen-1-
naphthalenyl]diazenyl]-, sodium salt yl]naphthalene-1-sulfonate
(1:2) disodium 8-anilino-5-({4-[(3- C&L Inventory, Registration dossier
1-Naphthalenesulfonic acid, 8- C&L Inventory sulfonatophenyl)diazenyl]-1-
(phenylamino)-5-[[4-[(3- naphthyl}diazenyl)naphthalene-1-
sulfophenyl)azo]-1- sulfonate
naphthalenyl]azo]-, disodium salt Disodium 8-phenylamino-5-[4-(3- Registration dossier
8-anilino-5-[[4-[(3- C&L Inventory sulfonatophenylazo)-1-
sulfophenyl)diazenyl]naphthalen- 1- naphthylazo]naphthalene-1-
yl]diazenyl]naphthalene-1-sulfonic sulfonate
acid Everacid TA08 C&L Inventory
8-anilino-5-[[4-[(3- C&L Inventory NA C&L Inventory
sulfophenyl)diazenyl]naphthalen-1- Not available C&L Inventory
yl]diazenyl]naphthalene-1-sulfonic SODIUM 8-PHENYLAMINO-5-(4-(3- C&L Inventory
acid SULPHONATEOPHENYLAZO)-1-
8-anilino-5-[[4-[(3- C&L Inventory NAPHTYLAZO)NAPHTALENESULPHONATE
sulfophenyl)diazenyl]naphthalen-1- sodium 8-phenylamino-5-(4-(3- C&L Inventory
yl]diazenyl]naphthalene-1-sulfonic sulphonatophenylazo)-1-
acid; sodium naphthylazo)naphthalenesulphonate
Acid Blue 113 Registration dossier Sodium 8-phenylamino-5-(4-(3- C&L Inventory
C.I. Acid Blue 113 C&L Inventory sulphonatophenylazo)-1-
disodium 8-(phenylamino)-5-((E)-(4- Registration dossier naphthylazo)naphthalenesulphonate
((E)-(3- Sodium 8-phenylamino-5-(4-(3- C&L Inventory, Registration dossier
sulfonatophenyl)diazenyl)naphthalen- sulphonatophenylazo)-1-
1-yl)diazenyl)naphthalene-1-sulfonate naphthylazo)naphthalenesulphonate
disodium 8-(phenylamino)-5-[(E)-2- Registration dossier
{4-[(E)-2-(3-sulfonatophenyl)diazen-
1-yl]naphthalen-1-yl}diazen-1-
yl]naphthalene-1-sulfonate
Trade names
Everacid TA08 C&L Inventory Triacid Milling Navy Blue 5RN Registration dossier
SELLA FAST NAVY R C&L Inventory
Other names

Other identifiers
3351-05-1 CAS number EC Inventory, C&L
Inventory, Registration
dossier, REACH pre-
registration

Scientific properties

Physical and chemical properties

This section provides physicochemical information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and
correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Appearance/physical state / colour

Study results 4 studies submitted Type of Study provided C Summaries 2 summaries submitted
4 studies processed 2 summaries processed

C Physical state at 20°C and 1013 hPa Studies with Data waiving Physical state at 20°C and 1013 hPa
   
Solid (100%) [4] data Solid (100%)
no waivers
Key study 4
C Form
Solid: particulate/powder (75%), Powder (25%) [4]

C Odour
Odourless (100%) [4]

C Substance type
Organic (100%) [4]

Melting/freezing point

Study results 4 studies submitted Type of Study provided R Summaries 1 summary submitted
0 studies processed 1 summary processed

Studies with Data waiving Melting / freezing point at 101 325 Pa

 No automatically processable data submitted    
data 342 °C
no waivers
Key study 4
Boiling point

Study results 4 studies submitted Type of Study provided Summaries 1 summary submitted
0 studies processed 0 summaries processed

 No automatically processable data submitted Studies with Data waiving  No automatically processable data submitted
   
data
Sci. unjustified 4

Density

Study results 4 studies submitted Type of Study provided R Summaries 1 summary submitted
1 study processed 1 summary processed

R Relative density Studies with Data waiving Relative density at 20°C

   
0.9 @ 20 °C [1] data 0.9
no waivers
Key study 4

Vapour pressure

Study results 5 studies submitted Type of Study provided R Summaries 1 summary submitted
1 study processed 1 summary processed

R Vapour pressure Studies with Data waiving Vapour pressure

   
0 Pa @ 25 °C [1] data 0 Pa @ 25 °C
Sci. unjustified 4
Weight of
1
evidence

Partition coefficient

Study results 4 studies submitted Type of Study provided R Summaries 1 summary submitted
4 studies processed 1 summary processed

R Log Pow Studies with Data waiving Log Kow (Log Pow)
   
-1.16 - -1.1 @ 20 - 25 °C and pH 6.56 - 6.8 [4] data -1 @ 20 °C
no waivers
Key study 4

Water solubility

Study results 4 studies submitted Type of Study provided R Summaries 1 summary submitted
4 studies processed 1 summary processed

R Water solubility (mass/vol.) Studies with Data waiving Water solubility

   
200 - 203.61 g/L @ 20 - 25 °C and pH 3.5 [4] data 100 g/L @ 20 °C
no waivers
Key study 4

Solubility in organic solvents / fat solubility  Data not provided by the registrant

Surface tension

Study results 4 studies submitted Type of Study provided Summaries 1 summary submitted
0 studies processed 0 summaries processed

 No automatically processable data submitted Studies with Data waiving  No automatically processable data submitted
   
data
Sci. unjustified 4

Flash point

Study results 4 studies submitted Type of Study provided Summaries 1 summary submitted
0 studies processed 0 summaries processed

 No automatically processable data submitted Studies with Data waiving  No automatically processable data submitted
   
data
Sci. unjustified 4

Auto flammability

Study results 4 studies submitted Type of Study provided R Summaries 1 summary submitted
0 studies processed 1 summary processed

Studies with Data waiving Autoflammability / self-ignition at 101 325 Pa

 No automatically processable data submitted    
data 359.7 °C
Sci. unjustified 3
Key study 1

Flammability

Study results 4 studies submitted Type of Study provided C Summaries 1 summary submitted
3 studies processed 1 summary processed

C Interpretation of results Studies with Data waiving Flammability

   
Not classified based on GHS criteria (100%) [3] data Non flammable (100%)
no waivers
Key study 4
Explosiveness

Study results 4 studies submitted Type of Study provided C Summaries 1 summary submitted
0 studies processed 1 summary processed

Studies with Data waiving Explosiveness

 No automatically processable data submitted    
data Non-explosive (100%)
Sci. unjustified 4

Oxidising

Study results 4 studies submitted Type of Study provided C Summaries 1 summary submitted
0 studies processed 1 summary processed

Studies with Data waiving Oxidising

 No automatically processable data submitted    
data No (100%)
Sci. unjustified 4

Oxidation reduction potential  Data not provided by the registrant

pH  Data not provided by the registrant

Dissociation constant  Data not provided by the registrant

Viscosity

Study results 1 study submitted Type of Study provided Summaries 1 summary submitted
0 studies processed 0 summaries processed

 No automatically processable data submitted Studies with Data waiving  No automatically processable data submitted
   
data
Sci. unjustified 1

Environmental fate and pathways

This section provides environmental fate and pathways information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The
quality and correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Phototransformation in air

Study results 1 study submitted Type of Study provided R Summaries 1 summary submitted
0 studies processed 1 summary processed

Studies with Data waiving Half life in air

 No automatically processable data submitted    
data 96.48 min
Sci. unjustified 1

Hydrolysis

Study results 1 study submitted Type of Study provided Summaries 1 summary submitted
0 studies processed 0 summaries processed

 Study data not processed for brief profile Studies with Data waiving  No automatically processable data submitted
   
data
Sci. unjustified 1

Phototransformation in water  Data not provided by the registrant

Phototransformation in soil  Data not provided by the registrant

Biodegradation in water - screening tests

Study results 6 studies submitted Type of Study provided C Summaries 1 summary submitted
4 studies processed 1 summary processed

C Interpretation of results Studies with Data waiving Biodegradation in water

   
Not readily biodegradable (100%) [4] data Inherently biodegradable (100%)
no waivers
Key study 1

Supporting
1 1
study

Weight of
3
evidence

Biodegradation in water & sediment - simulation tests

Study results 0 studies submitted Type of Study provided Summaries 1 summary submitted
0 studies processed 0 summaries processed

 Study data not processed for brief profile Studies with Data waiving  No automatically processable data submitted
   
data
no waivers

Biodegradation in soil

Study results 1 study submitted Type of Study provided Summaries 1 summary submitted
0 studies processed 0 summaries processed

 Study data not processed for brief profile Studies with Data waiving  No automatically processable data submitted
   
data
Sci. unjustified 1
Bioaccumulation: aquatic / sediment

Study results 0 studies submitted Type of Study provided R Summaries 1 summary submitted
0 studies processed 1 summary processed

Studies with Data waiving Bioaccumulation Factor (BCF) - L/kg ww

 Study data not processed for brief profile    
data 10 L/kg ww
no waivers

Bioaccumulation: terrestrial  Data not provided by the registrant

Adsorption/desorption

Study results 1 study submitted Type of Study provided Summaries 1 summary submitted
0 studies processed 0 summaries processed

 No automatically processable data submitted Studies with Data waiving  No automatically processable data submitted
   
data
Sci. unjustified 1

Henrys law constant (H)  Data not provided by the registrant

Distribution modelling  Data not provided by the registrant

Ecotoxicological information

This section provides ecotoxicological information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and
correctness of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Predicted No-Effect Concentration (PNEC)

R Summaries 1 summary submitted

1 summary processed

The Predicted No-Effect Concentration (PNEC) value is the concentration of a substance below which adverse effects in the environment are not expected to occur. Please note that when more
than one summary is provided, PNEC values may refer to constituents of the substance and not to the substance as a whole. More detailed information is available in the dossiers.

Hazard for Aquatic Organisms Hazard for Air

Freshwater 77.3 µg/L (1) Air No hazard identified (1)

Intermittent releases (freshwater) 773 µg/L (1) Hazard for Terrestrial Organism

Marine water 7.73 µg/L (1) Soil 15.16 µg/kg soil dw (1)

Intermittent releases (marine water) - Hazard for Predators

Sewage treatment plant (STP) 3.2 mg/L (1) Secondary poisoning No potential for bioaccumulation (1)

Sediment (freshwater) 302.7 µg/kg sediment dw (1)

Sediment (marine water) 32.7 µg/kg sediment dw (1)

Short–term toxicity to fish

Study results 2 studies submitted Type of Study provided Summaries 1 summary submitted
1 study processed 0 summaries processed

P/R Results Studies with Data waiving  No automatically processable data submitted
   
LC50 (4 days) 77.3 mg/L [1] data
no waivers
LC50 (48 h) 80 mg/L [1] Key study 1

Supporting
1
study

Long–term toxicity to fish  Data not provided by the registrant

Short–term toxicity to aquatic invertebrates

Study results 4 studies submitted Type of Study provided Summaries 1 summary submitted
1 study processed 0 summaries processed

P/R Results Studies with Data waiving  No automatically processable data submitted
   
EC50 (48 h) 220 mg/L [2] data
no waivers
EC0 (48 h) 220 mg/L [1] Key study 1
EC0 (24 h) 220 mg/L [1]
Weight of
EC100 (48 h) 220 mg/L [1] 3
evidence
EC100 (24 h) 220 mg/L [1]

Long–term toxicity to aquatic invertebrates  Data not provided by the registrant

Toxicity to aquatic algae and cyanobacteria

Study results 4 studies submitted Type of Study provided Summaries 1 summary submitted
0 studies processed 0 summaries processed

 No automatically processable data submitted Studies with Data waiving  No automatically processable data submitted
   
data
Not feasible 1
Weight of
3
evidence
Toxicity to aquatic plants other than algae

Study results 1 study submitted Type of Study provided R Summaries 1 summary submitted
1 study processed 1 summary processed

P/R Results Studies with Data waiving EC50 for freshwater plants
   
EC50 (7 days) 2.45 g/L [1] data 2.54 g/L
no waivers
Key study 1

Toxicity to microorganisms

Study results 1 study submitted Type of Study provided R Summaries 1 summary submitted
1 study processed 1 summary processed

P/R Results Studies with Data waiving EC50 for microorganisms

   
IC50 (3 h) 320 mg/L [1] data 320 mg/L
no waivers
Key study 1
EC10 or NOEC for microorganisms
320 mg/L

Sediment toxicity  Data not provided by the registrant

Endocrine disrupter testing in aquatic vertebrates – in vivo  Data not provided by the registrant

Toxicity to terrestrial macroorganisms except arthropods  Data not provided by the registrant

Toxicity to terrestrial arthropods  Data not provided by the registrant

Toxicity to terrestrial plants  Data not provided by the registrant

Toxicity to soil microorganisms  Data not provided by the registrant

Toxicity to birds  Data not provided by the registrant

Toxicity to mammals  Data not provided by the registrant

Toxicological information

This section provides toxicological information compiled from all automatically processable data from REACH registration dossiers that is available to ECHA at the time of generation. The quality and correctness
of the information remains the responsibility of the data submitter. The Agency thus cannot guarantee the correctness of the information displayed.

Derived No- or Minimal Effect Level (DN(M)EL)

M/C Summaries 1 summary submitted

1 summary processed

The derived no- or minimum effect level (DN(M)EL) is the level of exposure above which a human should not be exposed to a substance. Please note that when more than one summary is
provided, DN(M)EL values may refer to constituents of the substance and not to the substance as a whole. More detailed information is available in the dossiers.
Data for WORKERS Data for the GENERAL POPULATION

INHALATION Exposure Threshold Most sensitive study INHALATION Exposure Threshold Most sensitive study

Systemic Effects Systemic Effects

Long-term: (DNEL) 8.22 mg/m³ repeated dose toxicity Long-term: (DNEL) 1.25 mg/m³ repeated dose toxicity

Acute /short term: (No hazard identified) - Acute /short term: (No hazard identified) -

Local Effects Local Effects

Long-term: (Low hazard (no threshold derived)) - Long-term: (Low hazard (no threshold derived)) -

Acute /short term: (Low hazard (no threshold derived)) - Acute /short term: (Low hazard (no threshold derived)) -

DERMAL Exposure Threshold Most sensitive study DERMAL Exposure Threshold Most sensitive study

Systemic Effects Systemic Effects

Long-term: (Low hazard (no threshold derived)) - Long-term: (Low hazard (no threshold derived)) -

Acute /short term: (Low hazard (no threshold derived)) - Acute /short term: (Low hazard (no threshold derived)) -

Local Effects Local Effects

Long-term: (No hazard identified) - Long-term: (No hazard identified) -

Acute /short term: (No hazard identified) - Acute /short term: (No hazard identified) -

EYE Exposure ORAL Exposure Threshold Most sensitive study

Low hazard (no threshold derived) Systemic Effects

Long-term: (DNEL) 833 µg/kg bw/day repeated dose toxicity

Acute /short term: (No hazard identified) -

EYE Exposure

Low hazard (no threshold derived)

Toxicokinetics, metabolism, and distribution

Study results Type of Study provided Summaries 0 summaries submitted

0 summaries processed

Study data: basic toxicokinetics 1 study submitted Study data: basic toxicokinetics  No data available
0 studies processed

 Study data not processed for brief profile Studies with Data waiving
   
data
no waivers
Key study 1

Study data: dermal absorption 0 studies submitted Study data: dermal absorption
0 studies processed

 Study data not processed for brief profile Studies with Data waiving
   
data
no waivers

Acute toxicity

Study results Type of Study provided M/C Summaries 1 summary submitted

1 summary processed

Oral route:
oral 4 studies submitted oral
4 studies processed No adverse effect observed LD50 5 000 mg/kg bw

P/R Results Studies with Data waiving

   
LD50 5 000 mg/kg bw (rat) [4] data
no waivers
Key study 1 3
M/C Interpretations of results
GHS criteria not met [4]

inhalation 1 study submitted inhalation

1 study processed

M/C Interpretations of results Studies with Data waiving

   
GHS criteria not met [1] data
no waivers
Key study 1

dermal 1 study submitted dermal

0 studies processed

 No automatically processable data submitted Studies with Data waiving

   
data
Sci. unjustified 1

other routes 0 studies submitted other routes

0 studies processed

 No data available Studies with Data waiving

   
data
no waivers

Irritation / corrosion

Study results Type of Study provided M/C Summaries 1 summary submitted

1 summary processed

Skin
Study data: skin 9 studies submitted Study data: skin
0 studies processed No adverse effect observed (not irritating)

Eye
 Study data not processed for brief profile Studies with Data waiving
    Adverse effect observed (irritating)
data
Sci. unjustified 4
Key study 1 Respiratory

Supporting No study available

1
study

Weight of
3
evidence

Study data: eye 9 studies submitted Study data: eye

0 studies processed

 Study data not processed for brief profile Studies with Data waiving
   
data
Sci. unjustified 4
Key study 1 3

Supporting
1
study
Sensitisation

Study results Type of Study provided M/C Summaries 1 summary submitted

1 summary processed

Skin sensitisation
Study data: skin 8 studies submitted Study data: skin
0 studies processed Adverse effect observed (sensitising)

Respiratory sensitisation
 Study data not processed for brief profile Studies with Data waiving
    No study available
data
Sci. unjustified 4
Key study 1 3

Study data: respiratory 0 studies submitted Study data: respiratory

0 studies processed

 Study data not processed for brief profile Studies with Data waiving
   
data
no waivers

Repeated dose toxicity

Study results Type of Study provided M/C Summaries 1 summary submitted

1 summary processed

Oral route - systemic effects:

Study data: oral 1 study submitted Study data: oral
1 study processed No adverse effect observed NOAEL 500 mg/kg bw/day
(subacute, rat)

P/R Results Studies with Data waiving

   
NOAEL (rat): 500 mg/kg bw/day [1] data
no waivers
Key study 1

Study data: inhalation 0 studies submitted Study data: inhalation

0 studies processed

 No data available Studies with Data waiving

   
data
no waivers

Study data: dermal 0 studies submitted Study data: dermal

0 studies processed

 No data available Studies with Data waiving

   
data
no waivers

Genetic toxicity

Study results Type of Study provided M/C Summaries 1 summary submitted

1 summary processed

Toxicity - InVitro
Study data: in vitro 6 studies submitted Study data: in vitro
0 studies processed No adverse effect observed (negative)

Toxicity - InVivo
 Study data not processed for brief profile Studies with Data waiving
    No study available
data
no waivers
Key study 2 3

Supporting
1
study

Study data: in vivo 0 studies submitted Study data: in vivo

0 studies processed

 Study data not processed for brief profile Studies with Data waiving
   
data
no waivers

Carcinogenicity  Data not provided by the registrant

 Toxicity to reproduction

Study results Type of Study provided M/C Summaries 1 summary submitted

1 summary processed

Effect on fertility
Study data: reproduction 1 study submitted Study data: reproduction
0 studies processed
Oral route:
No adverse effect observed NOAEL 1 000 mg/kg bw/day
 Study data not processed for brief profile Studies with Data waiving (subacute, rat)
   
data
no waivers
Key study 1

Study data: developmental 1 study submitted Study data: developmental

0 studies processed

 Study data not processed for brief profile Studies with Data waiving
   
data
Sci. unjustified 1

Study data: other studies 0 studies submitted Study data: other studies
0 studies processed

 Study data not processed for brief profile Studies with Data waiving
   
data
no waivers

Neurotoxicity  Data not provided by the registrant

Immunotoxicity  Data not provided by the registrant

Endocrine disrupter mammalian screening - in vivo  Data not provided by the registrant

Legend Type of study Type of aggregation

 Experimental results C Concatenated distinct values

Read across based on R Range of values
grouping of substance
P/R Prioritisation (Eco)Toxicology AND Range of values
(category approach) or Read-

across from supporting M/C Most Conservative of values
substance (structural
analogue or surrogate)
Estimated by calculation or

(Q)SAR
Experimental study planned,

other or unspecified

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