Product Assessment Report - K-Othrine SC 25 Family Public

REPORT
2017-06-29
Our reference
F-2684-B13-00344
Product Assessment Report of a Biocidal Product Family

Related to product authorisation under Regulation (EU) No 528/2012
K-Othrine SC 25 Family
Products (trade names):

K-Othrine SC 25
K-Othrine SC 26.25
Type of application Product type
Authorisation PT 18 (insecticide)
Authorisation number for the biocidal product family Date of decision/Entry into
force
5327
29 June 2017
Authorisation number for the biocidal products Date of expiry
K-Othrine SC 25 (5327-1-1) 28 June 2027
K-Othrine SC 26.25 (5327-1-2)

Active substance User category
Deltamethrin, 2.43-2.52 % (w/w) Class 2 - Products for

professional use only
Sweden’s R4BP3 reference code
BC-FA010846-61
Page 1 of 142
CONTENTS
1 GENERAL INFORMATION ABOUT THE PRODUCT FAMILY APPLICATION 5
Applicant 5
1.1.1 Person authorised for communication on behalf of the applicant 5
Current authorisation holder 5
Proposed authorisation holder 6

1.3.1 Person authorised for communication on behalf of the proposed authorisation holder 6
Information about the product family application 6
Information about the biocidal product family 7

1.5.1 General information 7
1.5.2 Information on the intended use(s) 7
Uses claimed by the applicant 7
Uses authorised by the Reference Member State 8
1.5.3 Information on active substance 9
1.5.4 Information on the substance(s) of concern 9
Documentation 9
1.6.1 Data submitted in relation to product family application 9
1.6.2 Access to documentation 11
2 SUMMARY OF THE PRODUCT FAMILY ASSESSMENT 12
Information to the reader from the Ref-MS 12
Identity related issues 12

2.2.1 Identity of ingredients of the biocidal product 12
2.2.2 Information on the substance(s) of concern 12
Classification, labelling and packaging 12

2.3.1 Classification of the active substance deltamethrin 13
2.3.2 Proposed classification and labelling of the biocidal product 13
2.3.3 Packaging 13
Physico-chemical properties 14
Analytical methods for detection and identification 19

2.5.1 Analytical methods for the determination of deltamethrin in K-Othrine SC 25 20
2.5.2 Analytical methods for residues 20
EFFICACY 21
2.6.1 Function 21
2.6.2 Organisms to be controlled and products, organisms or objects to be protected 21
2.6.3 Effects on target organisms and efficacy 22
2.6.4 Mode of action including time delay 46
2.6.5 Occurrence of resistance 46
EXPOSURE ASSESSMENT 48
2.7.1 Human exposure assessment 48
Identification of main paths of human exposure towards active substance from its use in biocidal
product 49
Professional exposure 49
Page 2 of 142
Primary exposure 50
Non-professional exposure 54
Indirect exposure as a result of use of the active substance in biocidal product -Secondary
exposure 54
2.7.2 Environmental exposure assessment 61
Fate and distribution in the environment 62
2.7.2.1.1 Abiotic degradation 62
2.7.2.1.2 Biodegradation 62
2.7.2.1.3 Distribution 62
2.7.2.1.4 Accumulation 63
Emission pathways 63
2.7.2.2.1 Application practice 64
2.7.2.2.2 Treatment areas 65
2.7.2.2.3 Treatment intervals 65
2.7.2.2.4 Estimated environmental emissions during the application step 66
2.7.2.2.5 Estimated environmental emissions during the preparation step 68
2.7.2.2.6 Estimated environmental emissions during the cleaning step 71
2.7.2.2.7 Emission to wastewater of deltamethrin 72
2.7.2.2.8 Emission to wastewater of the major metabolite (Br2CA) 77
2.7.2.2.9 Fate of deltamethrin in the sewage treatment plant (STP) 79
2.7.2.2.10 Fate of Br2CA in the sewage treatment plant (STP) 82
2.7.2.2.11 Release of deltamethrin to surface water and sediment 83
2.7.2.2.12 Release of metabolite Br2CA to surface water and sediment 86
2.7.2.2.13 Release of deltamethrin to soil 86
2.7.2.2.14 Release of metabolite Br2CA to soil 89
2.7.2.2.15 Release of deltamethrin to groundwater 89
2.7.2.2.16 Release of metabolite Br2CA to groundwater 91
PEC in surface water, sediment, STP and ground water 92
PEC in air 99
PEC in soil 99
Non-compartmental-specific exposure relevant to the food chain (secondary poisoning) 102
Effects assessment 108

2.8.1 Human health effects assessment 108
Percutaneous absorption 108
Acute toxicity 108
Irritation and corrosivity 110
2.8.1.3.1 Skin irritation 110
2.8.1.3.2 Eye irritation 110
Sensitisation 111
Other 111
2.8.2 ENVIRONMENTAL EFFECTS ASSESSMENT 112
Aquatic compartment 112
Atmosphere 112
Terrestrial compartment 112
Non-compartment-specific effects relevant to the food chain (secondary poisoning) 112
HAZARD IDENTIFICATION FOR PHYSICO-CHEMICAL PROPERTIES 112
RISK CHARACTERISATION FOR HUMAN HEALTH 113

2.10.1 Critical endpoint(s) 113
2.10.2 Relevant exposure paths 113
2.10.3 Primary exposure 114
Professsional users 114
Non-professional users 115
2.10.4 Secondary exposure 115
2.10.5 Combined exposure 116
RISK CHARACTERISATION FOR THE ENVIRONMENT 118

2.11.1 Aquatic compartment (incl. sediments) 119
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2.11.2 atmospheric compartment 126
2.11.3 terrestrial compartment 126
2.11.4 Non-compartmental specific effects relevant to the food chain (secondary poisoning) 128
2.11.5 Conclusions 132
RISK CHARACTERISATION FOR THE PHYSICO-CHEMICAL PROPERTIES 133
MEASURES TO PROTECT MAN, ANIMAL AND THE ENVIRONMENT 133

2.13.1 Recommended Methods and Precautions Concerning Handling, Storage, Transport or Fire 133
3 PROPOSAL FOR DECISION 137
Background to the decision 137

3.1.1 General background 137
3.1.2 From the Assessment Report 137
3.1.3 Previous use and authorisation in Sweden 137
3.1.4 Conclusions from risk assessment of the product family 137
Proposal for decision 138
ANNEX 1: REFERENCE LIST 139
Page 4/142
1 GENERAL INFORMATION ABOUT THE PRODUCT FAMILY
APPLICATION
APPLICANT
Company Name: Bayer S.A.S.
Address: 16 rue Jean-Marie Leclair CS 90106
City: Lyon Cedex 09
Postal Code: F-69266
Country: France
Telephone:
E-mail address:
1.1.1 Person authorised for communication on behalf of the applicant
Name:
Function:
Address: 16 rue Jean-Marie Leclair, CS 90106
City: Lyon
Postal Code: F-69266 Cedex 09
Country: France
Telephone:
E-mail address:
CURRENT AUTHORISATION HOLDER
Company Name: Bayer AB
Address: Arne Jacobsens Allé 13
City: Köpenhamn S
Postal Code: 2300
Country: Denmark
Telephone:
E-mail address:
Letter of appointment for the Not applicable

applicant to represent the
authorisation holder provided
(yes/no):
Page 5/142
there is also a variation in the concentration of non-active substances. The
detailed information on product composition is presented in a separate
confidential annex.
INFORMATION ABOUT THE BIOCIDAL PRODUCT FAMILY
1.5.1 General information
Family name: K-Othrine SC 25 Family
Meta (second information level): K-Othrine SC 25-1
Individual products trade names (third K-Othrine SC 25

information level):
and
K-Othrine SC 26.25
Manufacturer’s development code number(s), if K-Othrine SC 25 (25 g/L):

appropriate:
specification 102000017408-03; UVP79112947
and
K-Othrine SC 26.25 (26.25 g/L):
specification 102000012399-02; UVP06520596
Product type: PT18
Composition of the product (identity and content Deltamethrin: 25 g/L (2.46 % w/w)
of active substance(s) and substances of concern; and
full composition see confidential annex):
Deltamethrin: 26.25 g/L (2.56 % w/w)
Formulation type: Suspension Concentrate (SC)
Ready to use product (yes/no): No
Is the product the very same (identity and K-Othrine SC 26.25 is one of the representative
content) to another product already authorised formulations submitted for EU review according to the
under the regime of directive 98/8/EC (yes/no); biocide directive 98/8/EC.
Has the product the same identity and K-Othrine SC 25 is proposed additionally in a biocidal
composition like the product evaluated in product family.
connection with the approval for listing of active
(See DocIIIB confidential data and information for
substance(s) on to Annex I to directive 98/8/EC
compositions comparison)
(yes/no):
1.5.2 Information on the intended use(s)
Uses claimed by the applicant
Overall use pattern (manner and area of use): Spray indoors in public health situations to control
crawling insects and flying insects when at rest.
Crawling and flying insects.
Target organisms:
Category of users: Professionals

Spray
Directions for use including minimum and
Dilute 50 mL product with water up to a total volume of
maximum application rates, application rates per
5L for 100m²
Page 7/142
time unit (e.g. number of treatments per day), Dilute 25 mL product with water up to a total volume of
typical size of application area: 5L for 100m²
Dilute 25 mL product with water up to a total volume of
10L for 100m²
Potential for release into the environment (yes/no): Conclusions regarding fate properties are presented for
the active substance deltamethrin in Doc IIA. It is
considered that the formulations of K-Othrine SC 25
and K-Othrine SC 26.25 will not significantly influence
the environmental fate and behaviour of the active
substance.
Potential for contamination of food/feedingstuff No.

(yes/no)
Proposed Label:
Use Restrictions: Detailed on proposed label
Uses authorised by the Reference Member State
Overall use pattern (manner and area of use): 1. Spray indoors for control of chronic infestations of
crawling insects (including cockroach) in domestic,
commercial and industrial buildings. Application rate:
50 mL product diluted with water up to 5 L for 100m2,
resulting in a dose of 12.5 mg/m2, for K-Othrine SC 25
and 13.1 mg/m2, for K-Othrine SC 26.25.
2. Spray indoors for control of localised infestations of

crawling insects (including cockroach) in domestic,
commercial and industrial buildings. Application rate:
25 mL product diluted with water up to 5 L for 100m2,
resulting in a dose of 6.25 for K-Othrine SC 25 and 6.56
mg/m2 for K-Othrine SC 26.25.
3. Spray indoors for control of flies when at rest, in

domestic, commercial and industrial buildings.
Application rate: 50 mL product diluted with water up
to 5 L for 100m2, resulting in a dose of 12.5 for K-
Othrine SC 25 and 13.1 mg/m2 for K-Othrine SC 26.25.
Use patterns 1 & 2: Crawling insects, including
Target organisms:
cockroaches.
Use patterns 3: Flies.
Category of users: Professional and trained professional users
For details of the uses authorised by the Reference Member State, please see the Summary of biocidal
Product Family Characteristics (SPFC), were both the products K-Othrine SC 25 and K-Othrine SC
26.25 are included in one meta-SPC (second information level of the SPFC).
Page 8/142
1.5.3 Information on active substance
Active substance chemical name: Deltamethrin
CAS No: 52918-63-5
EC No: 258-256-6
Purity (minimum, g/kg or g/l): 98.5 %w/w
Inclusion directive: Commission Directive 2011/81/EU
Date of inclusion: October 1st, 2013
Is the active substance equivalent to the active Yes

substance listed in Annex I to 98/8/EC (yes/no):
Manufacturer of active substance(s) used in the See SPFC

biocidal product:
1.5.4 Information on the substance(s) of concern

The biocidal products contain the co-formulants 1,2-benzisothiazol-3(2H)-one and reaction mass 5-
chloro-2-methyl-2H-isothiazol-3-one and 2-methyl-2H-isothiazol-3-one, which are active substances
under the review program for PT6, thus making them potential substances of concern (SoC). Ref-MS
has therefore considered whether these substances should be regarded as actual substances of concern
in the current evaluation, and concludes the following:
The amount of the mentioned substances in the K-Othrine SC 25 Family does not change the
classification of the product. In addition, no other grounds for concern have been identified. For these
reasons, 1,2-benzisothiazol-3(2H)-one and the mixture of 3(2H)-isothiazolone, 5-chloro-2-methyl- and
2-methyl-3(2H)-isothiazolone should not be considered to be SoCs in these products. In addition, the
application was submitted before relevant guidance on identification and assessment of SoC was
adopted. Guidance that has become available recently should therefore not be used for the evaluation
of the present biocidal product family.
Ref-MS therefore concludes that there is no need to further evaluate the potential substances of
concern in the biocidal products.
DOCUMENTATION
1.6.1 Data submitted in relation to product family application

Relevant data on the product family have been submitted for efficacy; toxicity.
All data were produced in studies of acceptable quality. The studies are listed in Annex 1 (Reference
List).
No new data is submitted in relation to the active substance. Summaries of studies to determine the acute
toxicity (oral and dermal toxicity, skin and eye irritation and dermal sensitisation potential) of the
product family are presented in Doc IIIB.
Page 9/142
2.3.1 Classification of the active substance deltamethrin
Classification Acute Tox. 3; H301
Acute Tox. 3; H331
Aquatic Acute 1; H400
Aquatic Chronic 1; H410
Pictograms
GHS06 GHS09
Signal word Danger
H301: Toxic if swallowed.
H331: Toxic if inhaled.
Hazard statements
H400: Very toxic to aquatic life.
H410: Very toxic to aquatic life with long lasting effects.
2.3.2 Proposed classification and labelling of the biocidal product
Classification Aquatic Acute 1

Aquatic Chronic 1
Pictograms
Signal word Warning

Hazard statements H410: Very toxic to aquatic life with long lasting effects.
EUH208: Contains 1,2-benzisothiazol-3(2H)-one. May produce an allergic
reaction.
EUH208: Contains Reaction mass 5-chloro-2-methyl-2H-isothiazol-3-one and 2-
methyl-2H-isothiazol-3-one. May produce an allergic reaction.
2 % of the mixture consists of components of unknown acute inhalation toxicity.
Precautionary statements P273: Avoid release to the environment.
P371: Collect spillage.
P501: Dispose of contents/container in accordance with local regulation.
2.3.3 Packaging
The biocidal product family K-Othrine SC 25 is sold in HDPE bottles from 25 mL up to 20 L.
Page 13/142
(olfactory):
2.7 Packaging stability No negative effects No negative effects
observed observed
HDPE
deformation of packaging no panelling, no no panelling, no
ballooning ballooning
leakage no leakage no leakage
effect on closure leak proof leak proof
packaging/preparation no claying, no claying,
interaction
no sedimentation no sedimentation
weight change Not determined Not determined
2.8.3 Spontaneity 99 % 101 %
(CIPAC MT 160)
in CIPAC D water
2.8.3 Suspensibility
(CIPAC MT 161)
0.03 % in CIPAC D water 97 % 96 %
0.2 % in CIPAC D water 97 % 97 %
2.8.5 Wet sieving < 0.01 % < 0.01 %
(CIPAC MT 185)
residue on a 75 μm sieve
2.8.8.2 Pourability
(CIPAC MT 148)
residue: 2.64 % 2.67 %
rinsed residue: 0.19 % 0.21 %
2.8.2 Persistent foaming
(CIPAC MT 47.2)
0.2 % in CIPAC D water
after 10 sec: 8 ml 4 ml
1 min: 5 ml 2.5 ml
3 min: 2.5 ml 2.5 ml
12 min: 1 ml 2.5 ml
Page 18/142
Table 2.6.3-1 Efficacy of the active substance from its use in the biocidal product (*)
Test Test system / Concentrations applied / Test

Test organisms Test results: effects, mode of action, resistance Reference
substance exposure time conditions
Deltamethrin Aedea aegypti L, The methodology used was the South Laboratory. Flying insects Pope, A. R. J.
SC 25 Musca domestica African Bureau of Standards method M-170824-01-1
L, Cimex Good control at 5 and 10 mg/m2
(S.A.B.S) number 583. B5-10-2/01
lectularius, Residual control up to 6 months.
Blatella The following deviations were noted; Crawling insects
germanica L and - Only Yellow Fever mosquitos (Aedea
aegypti) (L)), houseflies (Musca Good control at 10 and 20 mg/m2
American
cockroach domestica (L)), bedbugs (Cimex Residual control up to 6 months.
(Periplaneta lectularius), German cockroach (Blatella
germanica (L)) and American cockroach
Americana (L))
(Periplaneta Americana (L)) were used.
- Test panels, dilutions and belt speeds
were outlined in the study report.
Page 27/142
Test Test system / Concentrations applied / Test
Test organisms Test results: effects, mode of action, resistance Reference
substance exposure time conditions
Deltamethrin Grain weevil In house Laboratory. Sitophilus granaries Nentwig, G
SC25 (Sitophilus BES-EH-Mo 00954
granaries), Good control at 6.25 mg/m2 and 12.5 mg/m2.
B5-10-2/02
Confused flour Residual control up to 4 weeks for all surfaces apart
beetle (Tribolium from concrete, where residual efficacy was recorded
confusum) and at 3 weeks post application (4 weeks at the 12.5
German mg/m2 application rate).
cockroach
(Blattella Tribolium confusum
germanica). Good control at 6.25 mg/m2 and 12.5 mg/m2.
Residual control up to 4 weeks for all surfaces apart
from concrete, where residual efficacy was recorded
at 3 weeks post application for both application
rates.
Blattella germanica
Good control at 6.25 mg/m2 and 12.5 mg/m2.
Residual control up to 4 weeks for all surfaces apart
from concrete, where residual efficacy was recorded
at 3 weeks post application at an application rate of
6.25 mg/m2.
Page 29/142
2.6.4 Mode of action including time delay
Deltamethrin is a synthetic pyrethroid which acts on harmful organisms by contact and ingestion resulting
in death. Deltamethrin expresses a strong knock-down effect.
Pyrethroids impair ion transport through the membrane of nerve axons, causing muscular paralysis in the
insect; death seems to follow a nervous system impairment that occurs a few minutes to several hours after
pesticide absorption.
The primary site of activity of deltamethrin is the voltage sensitive sodium channel in nerve membrane.
Deltamethrin prolongs the opening of the sodium channels (i.e. the channels directly responsible for
generating nerve action potentials) leading to neuronal hyperexcitability.
2.6.5 Occurrence of resistance

Deltamethrin is a pyrethroid insecticide. Some resistance to pyrethroids has been found to varying
degrees, depending on the pest species and location (Anon, 1987 see Document III-A, section 5). In
Europe the main problems have occurred in some areas with pests of agricultural significance. Laboratory
tests on resistant strains have shown, for Myzus persicae, a resistance factor of 200 (to control the resistant
strain requires 200 times the dose required to control a sensitive strain).
A review by the WHO of Vector Resistance to Pesticides (Anon, 1992 see Document III-A, section 5)
identified no reports of resistance to synthetic pyrethroids in mosquitoes and other sucking insects in
Europe. However, resistance among some species of flies and cockroach populations was more evident.
Resistance to synthetic pyrethroids among European agricultural pest species, where insecticide use is
more intensive, may be more widespread (Anon, 2000).
Cross-resistance of pest species to the group of synthetic pyrethroids is to be anticipated due to a common
mode of action (Staetz, 2004 see Document III-A, section 5), and instances of cross-resistance (or multiple
resistance) between pyrethroids and organochlorine insecticides have been reported (Brogdon &
McAllister, 1998).
Because resistance is well known to be a potential problem, strategies to avoid resistance are normal
practice. For example, the use of alternating sequences, mixtures and avoidance of frequent repeated use
are standard.
General advice is provided by IRAC (Anon, 1987).
The principles of strategies for managing the development of resistance are similar for deltamethrin as
they are for other synthetic pyrethroids;
• where possible, application treatments should be recommended to be combined with non-
chemical measures
• products should always be used in accordance with label recommendations
• applications should always be made against the most susceptible stages in the pest life cycle
Page 46 of 142
• where an extended period of control is required, treatments should be alternated with products
with different modes of action
• levels of effectiveness should be monitored, and instances of reduced effectiveness should be
investigated for possible evidence of resistance, noting that sanitary conditions and proximity
of untreated refuges can contribute to the risk of re-infestation.
• in cases where label rates, correctly applied, fail to give the expected level of control and
resistance is demonstrated, use of any product containing the same class of chemistry should
cease
Page 47 of 142
Othrine SC 26.25 formulation: “Document II B2 Effects and Exposure Assessment for K-OTHRINE SC
26.25 of the non public CAR, final June 2011”.
Primary exposure
Main routes of operator exposure to K-Othrine SC 25 during mixing/loading and application are via
inhalation and by the dermal route. Primary exposure to professional operators may also occur during the
post-application phase (cleaning and maintenance).
Hence both situations will be assessed in this evaluation. In line with the CAR the exposure assessment
conducted for K-Othrine WG 250 will be used as a surrogate to assess exposure to K-Othrine SC 25.
A. Primary exposure during mixing/loading and application
As proposed in the CAR primary exposure during mixing/loading and application of the product will be
assessed considering the generic exposure figures given in the exposure model: "Low pressure insecticide
application. Professional operators mixing and loading liquids and powders in compression applicators,
and applying at 1 to 3 bar pressure as a coarse or medium spray, indoors and outdoors, overhead and
downwards; model 1" presented in Technical notes for guidance; Human exposure to biocidal products,
Guidance on human exposure assessment, June 2002. Exposure calculations will consider the same
generic exposure figures as being used in the CAR.
Further assumptions made for the calculations are summarized in the table below.
Page 50 of 142
different environmental compartments following use of K-Othrine SC 25, since the parent will potentially
have been subject to transformation either in situ or in the STP under very different environmental
conditions. Therefore, in order to estimate potential exposure of the major metabolite Br2CA, associated
with losses to the wastewater compartment during the service life of K-Othrine SC 25, it has been
assumed that the metabolite is formed within the environmental compartment in question at a quantity
equivalent to 100% of the parent (adjusted to take into account the molecular weights of the compounds).
The parent compound has a molecular mass of 505.2 g.mol-1, whilst the metabolite Br2CA has a molecular
mass of 298.0 g.mol-1. Therefore, the estimate of potential local exposure of the parent substance has been
adjusted by a factor of 0.59 (i.e. 298.0 / 505.2) to provide an estimate of exposure to the metabolite Br2CA
following suggested use. Where pertinent, the characterstics, e.g. Henry’s Law’s constant and partitioning
coefficient, of Br2CA has been incorporated in the calculations.
2.7.2.1.4 Accumulation
The bioaccumulation of 14C-deltamethrin was investigated in bluegill sunfish (Lepomis macrochirus). The
BCF values obtained were 310, 2800 and 1400 for edible, non-edible and whole body tissue, respectively.
After the 14-day depuration period 70, 75 and 76% of the 14C-residues had been eliminated from the
edible, non-edible and whole body tissue, respectively. The biological half-life was 4.3 days for whole
body tissue. The potential for bioconcentration of deltamethrin in earthworms was estimated by modelling
the hydrophobic partitioning between soil pore water and the phases inside the organism, in accordance
with equation 82d in the TGD. Using the Kow of 40 200 for deltamethrin, the BCFearthworm was 483.
Assessments of the potential for secondary poisoning via terrestrial and aquatic food chain indicate that
there is no unacceptable risk for earthworm- and fish-eating birds and small mammals.
For further details of the assessment of the environmental fate and behaviour of the active substance contained in
biocidal product(s), refer to the chapter on Fate and distribution in the environment Doc. II-A in the CAR.
Emission pathways
Various life-cycle stages can be distinguished in the environmental exposure assessment. The manufacture
of the active ingredient, deltamethrin, does not take place in the EU, and is thus not further discussed. The
formulation of K-OTHRINE SC25-SC26.25 takes place at manufacturing plants that are strictly regulated.
These plants have been audited by BCS IOP, and have demonstrated compliance with BCS production
guidelines. In addition, the formulation plants are ISO 9001 certified, and adhere to the ICPE legislation
(Installation Classified for the Protection of the Environment). All wastewater produced during
formulation and cleaning of manufacturing equipment is collected and incinerated. Emission limits govern
the release of dust from the plants. Since all hazardous wastes are eliminated in incineration facilities, it is
therefore proposed that no unacceptable emissions will occur during the formulation stage of the product
life cycle.
Potential emissions to the environment are possible during the preparation, application and cleaning steps
of the product life cycle. These emissions are considered in the following sections. The potential for
environmental exposure has been evaluated with specific reference to the local environmental scale. Due
to the nature of the product preparation and application procedure, it would be expected that, in most
cases, any environmental exposure would be localised in nature. It is therefore assumed that any
contribution from the regional scale would be so low that it could be considered negligible.
For the waste disposal stage of the product life cycle, it is considered that exposure to the wastewater
compartment by washing application equipment, or by illegal disposal, should not occur. It should be
noted that disposal of insecticide residues to wastewater is not recognised as a potential exposure pathway
Page 63 of 142
2.7.2.2.4 Estimated environmental emissions during the application step
K-OTHRINE SC25-SC26.25 is applied by trained professionals in a range of facilities. In compliance
with the ESD for insecticides for household and professional uses, dated 17th July 2008 (PT18; OECD,
2008) and Biocides Technical Meeting agreements, this risk assessment uses the default areas for typical
application to domestic household and larger buildings, as presented in the table below.
Page 66 of 142
Table 2.7.2.2.4-1 Typical area treated for different treatments and facilities
Treatment type Facility Treated area (m2)
Domestic household 2*
Crack and crevice
Larger building 9.3†
Domestic household 5.9†
Barrier
Larger building 27†
* Default area proposed in the ESD PT18 (OECD, 2008)
† Default areas agreed at the Biocides Technical Meeting (TMII 2010), as published in the Manual of Technical Agreements v. 6 (European
Commission, 2013)
There are two recommended application rates for the product (ApplAI). The typical application rate
(0.0065625 g.m-2) is recommended for the treatment of localised infestations of crawling insects and
flying insects, while the maximum application rate (0.013125 g.m-2) is intended for the residual control of
crawling insects in chronic infestations.
K-OTHRINE SC25-SC26.25 is applied by spraying, and therefore the default emission fractions for spray
application to air, applicator, floor and treated surfaces were considered. Emission to each compartment is
calculated as follows:
E Application , compartment = Appl AI × N appl × FApplication , compartment × AREAtreated × 10 3
Where:
Variable/parameter Symbol Unit Value Source

0.0065625 or
Appln rate of the substance ApplAI [g.m-2] Input
0.013125
Treated area per house AREAtreated [m2] - Default*
Number of appln per day Nappl, building [d-1] 1 Default**
Fraction emitted to air Fapplication, air [-] 0.02 Default**
Fraction emitted to applicator Fapplication, applicator [-] 0.02 Default**
Fraction emitted to floor Fapplication, floor [-] 0.11 Default**
Fraction emitted to treated surface Fapplication, treated [-] 0.85 Default**
Emission to air Eapplication, air [mg.d-1] - Output
Emission to applicator Eapplication, applicator [mg.d-1] - Output
Emission to floor Eapplication, floor [mg.d-1] - Output
Emission to treated surface Eapplication, treated [mg.d-1] - Output
* Default area values from ESD PT18 (OECD, 2008) and TM II 2010 (see table above: Typical area treated for different treatments and
facilities)
** Default values from ESD PT18 (OECD, 2008)
The estimated emission values to the relevant compartments from each scenario are presented in the table
below.
Page 67 of 142
Table 2.7.2.2.4-2 Emission to the air, applicator, floor and treated area compartments from the
application step
Eapplication,
Treatment Eapplication, air Eapplication, floor Eapplication, treated
Facility applicator
type [mg.d-1] [mg.d-1] [mg.d-1]
[mg.d-1]
Typical application rate for crawling and flying insects (0.0065625 g m-2)
Crack and Domestic household 0.26 0.26 1.44 11.16
crevice Larger building 1.22 1.22 6.71 51.88
Domestic household 0.77 0.77 4.26 32.91
Barrier
Larger building 3.54 3.54 19.49 150.61
Maximum application rate for crawling insects (0.013125 g.m-2)
Crack and Domestic household 0.53 0.53 2.89 22.31
crevice Larger building 2.44 2.44 13.43 103.75
Domestic household 1.55 1.55 8.52 65.82
Barrier
Larger building 7.09 7.09 38.98 301.22
2.7.2.2.5 Estimated environmental emissions during the preparation step
K-OTHRINE SC25-SC26.25 is packaged in HDPE bottle (up to 20 litres). Professional pest control
officers would prepare a sprayer batch of treatment solution that would be sufficient to treat a number of
buildings. To determine the number of preparations required per day per building (Nprep,building),
consideration has been given to the amount required for each individual treatment, and thus the number of
buildings treated by a typical 5 L sprayer.
Q AI , appl ,building = Appl AI × N appl , building × AREAtreated
Q prod , prep × FAI

N building , sprayer =
Q AI , appl , building
Page 68 of 142
Where:
Application rate of the substance ApplAI [g m-2] - Input
Treated area per house AREAtreated [m2] - Default*
Number of appln per day per building Nappl, building [d-1] 1 Default**
Quantity of a.s. applied per building per treatment QAI, appl, building [g] - Calculated
Volume of product required for preparation of a 5 L sprayer Qprod, prep [mL] - Input
Concentration of active substance in the commercial
FAI [g mL-1] 0.02625 Input
product
Number of buildings treated by a 5 L sprayer Nbuilding, sprayer [-] - Calculated
* Default area values from ESD PT18 (OECD, 2008) and TM II 2010 (see table above: Typical area treated for different treatments and
facilities)
** Default values from ESD PT18 (OECD, 2008)
As a number of buildings can be treated by a 5 L sprayer, a preparation event would not occur at every
treated facility. Therefore, the number of preparation events per building will be a fraction of the total
number of buildings treated, calculated as follows:
1
N prep ,building =
N building , sprayer
The estimated number of buildings treated by a typical 5 L sprayer, depending on the treatment, is
reported in the table below.
Page 69 of 142
Table 2.7.2.2.5-1 Quantity of product used for the preparation step, quantity of active substance
required per treatment (QAI, appl, building), number of buildings treated by a 5 L spray (Nbuilding, sprayer)
and proportion of buildings where a preparation step occurs (Nprep, building)
Treatment Qprod, prep QAI, appl, building Nbuilding, sprayer Nprep, building
Facility
type [mL] [g] [-] [-]
Typical application rate for flying and crawling insects (0.0065625 g m-2)
Crack and Domestic household 25 0.013125 50 0.02
crevice Larger building 25 0.06103125 11 0.093
Domestic household 25 0.03871875 17 0.059
Barrier
Larger building 25 0.1771875 4 0.27
Typical application rate for flying and crawling insects (0.0065625 g m-2) – porous surfaces
Crack and Domestic household 12.5 0.013125 25 0.04
crevice Larger building 12.5 0.06103125 5 0.186
Domestic household 12.5 0.03871875 8 0.118
Barrier
Larger building 12.5 0.1771875 2 0.54
Maximum application rate for crawling insects (0.013125 g.m-2)
Crack and Domestic household 50 0.02625 50 0.02
crevice Larger building 50 0.1220625 11 0.093
Domestic household 50 0.0774375 17 0.059
Barrier
Larger building 50 0.354375 4 0.27
For each treated building, emission from the preparation step can be calculated as follows:
E prep , compartment = Q prod , prep × FAI × N prep , building × F prep , compartment × 10 3
Where:
Concentration of active substance in the
FAI [g.mL-1] 0.02625 Input
commercial product
Volume of product required for preparation
Qprod, prep [mL] - Input
of a 5 L sprayer
Number of preparation per day per building Nprep, building [d-1] - Calculated
Fraction emitted to air Fprep, air [-] 0 Default*
Fraction emitted to applicator Fprep, applicator [-] 0.0012 Default**
Fraction emitted to floor Fprep, floor [-] 0.0005 Default***
Emission to air Eprep, air [mg.d-1] - Output
Emission to applicator Eprep, applicator [mg.d-1] - Output
Emission to floor Eprep, floor [mg.d-1] - Output
* Default value from ESD PT18 (OECD, 2008)
** Default value for liquids, from ESD PT18 (OECD, 2008)
*** Proposed worst case default value for professional use of liquids containers, from ESD PT18 (OECD, 2008)
Page 70 of 142
Due to the low vapour pressure of deltamethrin (1.24E-08 Pa at 25°C), volatile losses during the
preparation step are unlikely. The estimated emission values to the relevant compartments from each
scenario are presented in the table below.
Table 2.7.2.2.5-2 Estimated emission to the floor and applicator from the preparation step, per
building treated
Eprep, floor Eprep, applicator
Treatment type Facility
[mg.d-1] [mg.d-1]
Crawling and flying insects (Typical application rate of 0.0065625 g.m-2)
Domestic household 0.0066 0.0158
Crack and crevice
Larger building 0.0305 0.0732
Barrier
Crawling insects (Maximum application rate of 0.013125 g m-2)
Crack and crevice
Barrier
The product label for K-OTHRINE SC25-SC26.25 states that the PCO must ensure that sprayer is clean
and free of oily residues before use. If it is necessary to wash out the sprayer with water and detergent
before use and after use, the resulting washings must be treated according to national legislation. Since the
product is only applied by trained professionals following best practice guidelines, exposure to the
wastewater compartment by washing spray equipment, or by illegal disposal, should not occur.
2.7.2.2.6 Estimated environmental emissions during the cleaning step
During the cleaning step, emissions are considered both to solid waste and to wastewater. In accordance
with the ESD for PT18 (OECD, 2008), two conservative cases are considered:
• 100% emission to wastewater, assuming treated areas, floor areas and operator clothes are washable
(Fww = 1; Fw = 0)
• 100% emission to solid waste, assuming treated areas and floor areas are vacuum/broom cleaned
and operator’s coveralls are disposable (Fww = 0; Fw = 1)
Where:
Variable/parameter Symbol Unit Value Source*
Fraction emitted to wastewater during the cleaning step Fww [-] - Default
Fraction emitted to solid waste during the cleaning step Fw [-] - Default
Page 71 of 142
Emission to applicator from the application step Eapplication, applicator [mg.d-1] - Input
Emission to floor from the preparation step Eprep, floor [mg.d-1] - Input
Emission to floor from the application step Eapplication, floor [mg.d-1] - Input
Emission to treated surface from the application step Eapplication, treated [mg.d-1] - Input
Fraction emitted to wastewater during the cleaning step Fww [-] 1 Default*
Cleaning efficiency FCE [-] - Input
Emission to wastewater during the cleaning step Ewastewater [kg.d-1] - Output
* Default values from ESD PT18 (OECD, 2008)
On the local scale, in order to estimate the emission of deltamethrin to the local sewage treatment plant
(STP), assumptions are made regarding the typical number of buildings and the use of the product within
the STP catchment. It is assumed that 4000 domestic households + 300 commercial buildings are covered
within an STP catchment, based on the guidance in the Manual of Technical Agreement v6 (European
Commission, 2013) for PT 18 (TM I 2010).
Regarding the use of the product within the catchment area, reference is made in the ESD for PT 18 to a
French survey on the frequency of insecticide use by the general public. In this survey, the general public
was questioned on the use of insecticide and positive answers were split into band of usage frequency. The
results of the survey are presented in the table below.
Table 2.7.2.2.7-2 Responses to French survey of insecticide use by the general public (OECD 2008)
Frequency of use Positive answers (%) % of houses treated per day
One time per day 2.77 100
One time per week 9.51 14.3
One time per month 17.74 3.22
Three to eleven times per year 32.15 1.9
One to two times per year 37.82 0.54
In accordance with the ESD (PT 18; OECD, 2008) and conservatively assuming that 100% of the
domestic households within the catchment are treated with insecticides at least once a year, the percentage
of simultaneous use can be estimated using the following equation:
100 × 2.77 + 14.3 × 9.51 + 3.22 × 17.74 + 1.9 × 32.15 + 0.54 × 37.82
Fsimul tan eity = = 5.52%
100
However, in the case of K-OTHRINE SC25-SC26.25, it is known that the product will not be used on a
daily, weekly or monthly basis. The product exhibits sustained residual activity (up to three months)
Page 74 of 142
where residues remain undisturbed, with repeat treatments carried out only as necessary (e.g. every three
months, or longer, if target pests re-infest). Thus, the numbers relating to these frequencies can be
removed from the Fsimultaneity calculation. The revised value of Fsimultaneity is calculated as follows:
1.9 × 32.15 + 0.54 × 37.82

Fsimul tan eity = = 0.815%
100
Therefore, emission to local STP can be calculated as follows:
Elocal water = E wastewater × Fsim × N Buildings
For 4000 domestic households + 300 commercial buildings:
Elocalwater = (300 × Ewastewater(Large building) + 4000 × Ewastewater (Domestic household)) × Fsimultaneity
Example calculation for crawling and flying insects (crack and crevices; maximum application rate of
0.013125 g a.s..m-2):
Elocalwater = (300 × 2.02E-05 + 4000 × 4.34E-06) × 0.00815 = 1.91E-04 kg.d-1
Where:

Emission to wastewater during the cleaning step Ewastewater [kg.d-1] - Input
Factor of simultaneous use Fsim [-] 0.00815 Input
Number of building per catchment NBuildings [-] - Default*
Local emission to (waste) water during episode Elocalwater [kg.d-1] - Output
* Default values from ESD for PT18 (OECD, 2008) and subsequent guidance
The estimated emission values of deltamethrin to the wastewater compartment for each treatment scenario
are given in the tables below.
Page 75 of 142
Crack and crevice 1.91E-04
Barrier 1.70E-03
Table 2.7.2.2.7-4b Estimated emission of deltamethrin to wastewater within a STP catchment

(Elocalwater; based on 300 commercial buildings + 4000 households) using
Treatment type Elocalwater [kg.d-1]

Barrier 2.88E-04
Barrier 5.77E-04
2.7.2.2.8 Emission to wastewater of the major metabolite (Br2CA)
It is recognised that degradation of deltamethrin residues may result in the formation of the major
metabolite, Br2CA. No data are available concerning the formation of Br2CA from residual deposits of
deltamethrin in treated areas. Similarly, little data is available to reliably estimate the potential formation
of the compound in the sewer and the STP. Therefore, in order to estimate potential environmental
exposure to the major metabolite Br2CA, it has been assumed that the metabolite is formed during the
treatment period at a quantity equivalent to 100% of the parent (adjusted to take into account the
molecular weights of the compounds). This represents an unrealistic worst case, as experimental data has
shown that Br2CA is only transient, and is likely to be formed at only a fraction of the applied quantity of
parent deltamethrin; in contrast, this scenario assumes that the parent is entirely degraded while the
metabolite remains stable. Furthermore, it is assumed that there is no degradation during travel in the
sewer or in the sewage treatment plant.
Potential emissions of Br2CA to wastewater were calculated based on the procedure used for the parent
calculations, with the following considerations:
Quantity of substance applied:
The parent compound has a molecular mass of 505.2 g.mol-1, while metabolite Br2CA has a molecular
mass of 298.0 g.mol-1. Therefore, the estimated potential emissions of deltamethrin at the application and
preparation steps have been adjusted by a factor of 0.59 (i.e. 298.0 / 505.2), as shown below.
Page 77 of 142
MOLWmet
Appl met = Appl AI ×
MOLW AI

Appln rate of the active ingredient ApplAI [g m-2] - Input
Molecular weight of the active ingredient MOLWAI [g mol-1] 505.2 Input
Molecular weight the metabolite MOLWmet [g mol-1] 298.0 Input
Appln rate of the metabolite Applmet [g m-2] - Output
Cleaning efficiency:
Estimated emissions of Br2CA to the wastewater compartment for each treatment scenario are presented in
the tables below.
Table 2.7.2.2.8-1 Estimated emission of Br2CA to wastewater from a single treated building
(Ewastewater)
Treatment type Facility Ewastewater [kg.d-1]
Domestic household 1.28E-06
Crack and crevice
Larger building 5.95E-06
Barrier
Crack and crevice
Barrier
Table 2.7.2.2.8-2 Estimated emission of Br2CA to wastewater within a STP catchment (Elocalwater;
based on 300 commercial buildings + 4000 households)
Treatment type Elocalwater [kg.d-1]
Page 78 of 142
Estimated concentrations of Br2CA in STP influent, effluent and dry sewage sludge, calculated by
assuming 100% degradation of the parent prior to emission to the STP, are given in section 2.7.2.3.
2.7.2.2.11 Release of deltamethrin to surface water and sediment
In accordance with the guidance provided in the Technical Guidance Document, the local concentration of
deltamethrin in the receiving surface water compartment is calculated as follows:
Kpsusp = FOCsusp * Koc
Clocal eff
Clocal water =
(1 + Kp susp * SUSPwater * 10 −6 ) * DILUTION
PEClocal water = Clocal water
Where:
Partition coefficient organic carbon-water Koc [L.kg-1] 408250 Input
Weight fraction of organic carbon of suspended matter FOCsusp [kg kg-1] 0.1 Default*
Concentration of substance in the STP effluent Clocaleff [mg.L-1] - Calculated
Solids-water partitioning coefficient of suspended
Kpsusp [L.kg-1] 40825 Calculated
matter
Concentration of suspended matter in the river SUSPwater [mg.L-1] 15 Default*
Dilution factor DILUTION - 10 Default*
Local concentration in surface water during emission
Clocalwater [mg.L-1] - Output
episode
* Default values taken from the Technical Guidance Document (European Commission, 2003)
The predicted concentration of deltamethrin in aquatic sediment is calculated according to the guidelines
presented in the Technical Guidance Document. In order to estimate the concentration in aquatic sediment
for deltamethrin, a number of partition coefficients were derived:
Sediment water partition coefficient (L.kg-1):

Kp susp = Koc × Foc susp
Page 83 of 142
Suspended sediment-water equilibrium partition distribution coefficient (m3.m-3):
Kpsusp
K susp − water = Fwater + Fsolid × × RHOsolid
1000
Page 84 of 142
Where:
Variable/parameter (unit) Symbol Unit Value Source*
Partition coefficient organic carbon -water Koc [L kg-1] 408250 Input
Fraction organic carbon in the suspended matter Focsusp [-] 0.1 Default
Partition coefficient solid-water in suspended matter Kpsusp [L kg-1] 40825 Output
Fraction water in suspended matter Fwater [-] 0.9 Default
Fraction solid in suspended matter Fsolid [-] 0.1 Default
Bulk density of solid phase RHOsolid [kg.m-3] 2500 Default
Suspended matter-water equilibrium partition distribution
Ksusp-water [m3 m-3] Output
coefficient
* All default values were taken from the Technical Guidance Document (European Commission, 2003)
Therefore:
Sediment water partition coefficient (L.kg-1):

Kp susp = 408250 × 0.1 = 40825
Suspended sediment-water equilibrium partition distribution coefficient (m3.m-3):

40825
Ksusp − water = 0.9 + 0.1× × 2500 = 10207.15
1000
The concentration in bulk sediment can be derived from the predicted concentration in surface water,
assuming a thermodynamic partitioning equilibrium:
K susp − water
PECsed = × PECsw × 1000
RHOsusp
Where:
Concentration in surface water during episode PECsw [mg.L-1] - Input
Suspended matter-water partitioning coefficient Ksusp-water [m3.m-3] 10207.15 Input
Bulk density of suspended matter RHOsusp [kg.m-3] 1150 Default
Predicted environmental concentration in sediment PECsed [mg kg-1] - Output
Estimated concentrations of deltamethrin in surface water and sediment are given in section 2.7.2.3.
Page 85 of 142
Concentration in soil due to sludge in first year
Csludgesoil 1 (0) [mg kgwwt-1] - Output
at t = 0
** Values for mixing depth of soil and dry sludge application rate depend upon the endpoint being considered (see table below)
The Technical Guidance Document suggests that PECs for three different soils should be generated using
this equation: a PEC in local soil for comparison against terrestrial ecosystem endpoints, a PEC in
agricultural soil for comparison against crop endpoints for human consumption, and a PEC in grassland
soil for comparison against endpoints in grass for cattle. Different values for the mixing depth of soil and
dry sludge application rate are applicable, depending upon the endpoint being considered. These default
values are summarised in the table below.
Table 2.7.2.2.13-1 Characteristics of soil and soil-use for the three different endpoints (taken from
the Technical Guidance Document, European Commission, 2003)
Rate of sludge
Averaging time Bulk soil density
Soil Depth of soil (m) application
(days) (kgwwt m-3)
(kgdwt m2.yr-1)
Local soil 0.20 30 0.50 1700
Agricultural Soil 0.20 180 0.50 1700
Grassland Soil 0.10 180 0.10 1700
In accordance with the guidance presented in the Technical Guidance Document, worst-case initial PEC
values were calculated for deltamethrin in local soil, agricultural soil and grassland soil. These initial
PECs are given in section 2.7.2.5.
Based upon the estimated initial concentrations in soil after one sludge application, the potential
persistence of the substance in soil was investigated to establish the plateau maximum concentration in
soil. This was carried out using the standard soil degradation equation:
PEC(t) = PIEC × e-kt
Where:
PIEC Initial concentration in soil (mg.kg-1)
k ln2/DT50 (day -1)
t time period (days)
DT50 half-life of degradation in soil (days)
Using a soil DT50 value for deltamethrin of 48.2 days (geometric mean of DT50 values derived from four
different soils, normalised to 12°C and pF2 / field capacity), calculations were carried out in a Microsoft
Excel spreadsheet to simulate the dissipation of deltamethrin after successive sludge applications,
assuming a sludge application interval of one year. The calculations were carried out using a daily time-
step. The total concentration present in soil at any one time was calculated as the sum of the residues in
soil remaining from each of the annual sludge application events. The resulting pattern of deltamethrin
dissipation in soil over a ten year period is summarised in the figure below.
Page 87 of 142
120
100
Concentration (% of initial)
80
60
40
20
0
0 1 2 3 4 5 6 7 8 9 10
Tim e (Years)
Figure 2.7.2.2.13-1 Potential for accumulation of deltamethrin residues in soil after ten consecutive
annual sludge application events
From the figure above it can be seen that, following annual applications of sludge, concentrations of
deltamethrin in soil fall quickly into a steady pattern. This reflects the relatively short half-life of the
compound in soil, and therefore its low levels of carryover. An accumulation factor of 100.53% was
calculated, with the maximum plateau concentration predicted to be reached immediately after the fifth
annual sludge application. Predicted initial concentrations of deltamethrin in soil were therefore adjusted
to take into account this very small potential for carryover; these adjusted PECs are given in section
2.7.2.5.
The Technical Guidance Document (European Commission, 2003) advises that time-weighted average
concentrations in soil over specified time periods should be calculated for risk assessment purposes.
Different averaging times should be considered for various endpoints: for the ecosystem, a period of 30
days after application of sludge is used, whereas in order to determine biomagnification effects and
indirect human exposure, it is more appropriate to use an extended period of 180 days. Time-weighted
average concentrations in soil were calculated using the following equation, assuming a DT50 of 48.2 days
for deltamethrin, and based on initial soil concentrations following repeated sludge applications:
TWA PEC(t) = PIEC × (1-e-kt)/kt
Page 88 of 142
In the case of an evaluation for terrestrial ecosystems t = 30 days, whilst t = 180 days for agricultural and
grassland soils is more relevant to the assessment of bioaccumulation potential and porewater
concentrations as a screening approach for groundwater assessment.
Estimated time-weighted average concentrations of deltamethrin in soil following sludge application to

land are given in section 2.7.2.5.
2.7.2.2.14 Release of metabolite Br2CA to soil
Degradation of deltamethrin residues may result in the formation of the major metabolite Br2CA in soil. It
is difficult to predict the quantity of metabolite Br2CA present in soil after sludge application, since
transformation of the parent may have occurred either in soil or in the sludge itself, under very different
environmental conditions. Conservatively, it has been assumed that 100% transformation of the parent
into Br2CA takes place within the sludge, prior to application. To provide estimates of exposure for
metabolite Br2CA, predicted instantaneous concentrations of deltamethrin in sludge were therefore
adjusted by a factor of 0.59 to account for the difference in molecular weight between the parent and
metabolite (298.0 / 505.2). These values are given in table 2.7.2.3-2. It should be noted that the soil PEC
values calculated using these sludge concentrations represent extreme worst-case estimates of exposure,
since laboratory data indicate that Br2CA is formed at a maximum of only 23% from the parent
deltamethrin in aerobic soils after 14 days (Wang, 1991).
There is no persistence potential between successive sludge application events as the metabolite Br2CA is
quickly degraded in soil. Time-weighted average concentrations of Br2CA in soil were estimated using the
same method as for deltamethrin, based on the maximum instantaneous concentration after a single sludge
application. These calculations were carried out using a geometric mean DT50 for Br2CA of 5.6 days,
taken from the three soils normalised to 12°C and pF2 (field capacity). It is recognised that, in reality, the
formation and degradation of the metabolite Br2CA is a more complex process, giving rise to much lower,
more steady state concentrations in soil. However, the calculations included here provide worst case
values for risk assessment purposes.
Estimated time-weighted average concentrations of Br2CA in soil following sludge application to land are
given in section 2.7.2.5.
2.7.2.2.15 Release of deltamethrin to groundwater
It is recognised that there may be some potential for residues of deltamethrin present in soil to be
transported via leaching to groundwater. In accordance with the guidance presented in the Technical
Guidance Document (European Commission, 2003), the concentration of each compound in soil
porewater has been calculated to provide an indication of the potential groundwater contamination risk.
This approach is recognised as a suitable first-tier method of estimating groundwater exposure. It should
be noted that this is a worst-case approach, neglecting transformation, sorption and dilution.
Page 89 of 142
In order to estimate the concentration of deltamethrin in soil pore water, a number of partition coefficients
are derived:
Air water partition coefficient [-]

HENRY
Kair − water =
R × TEMP
Soil water partition coefficient (L.kg-1):

Kpsoil = Koc × Foc
Soil-water equilibrium partition distribution coefficient (m3.m-3):

Kpsoil
Ksoil − water = Fair × Kair − water + Fwater + Fsolid × × RHOsolid
1000
Where:
Henry’s Law Constant HENRY [Pa.m3 mol-1] 1.25E-03 Input
Gas constant R [Pa.m3 mol-1 k-1] 8.314 Default
Temperature at the air-water interface TEMP [K] 285 Default
Air-water partitioning coefficient Kair-water [-] - Output
Partition coefficient organic carbon -water Koc [L kg-1] 408250 Input
Fraction organic carbon in the soil Foc [-] 0.02 Default
Soil water partition coefficient Kpsoil [L kg-1] - Output
Fraction air in soil Fair [-] 0.2 Default
Fraction water in soil Fwater [-] 0.2 Default
Fraction solid in soil Fsolid [-] 0.6 Default
Bulk density of solids RHOsolid [kg.m-3] 2500 Default
Soil-water equilibrium partition distribution
Ksoil-water [m3.m-3] - Output
coefficient
Therefore, for deltamethrin:
Air water partition coefficient [-]:
1.25 × 10 −03
Kair − water = = 5.28 × 10 −07
8.314 × 285
Page 90 of 142
Although it has been concluded that deltamethrin does not present a risk to secondary poisoning,
quantitative estimations of the potential for bioaccumulation of deltamethrin from consumption of
earthworms and fish are presented in this risk assessment.
Diet sourced from the aquatic compartment
A BCF of 1400 for whole body tissue , 1990) has been used in this risk assessment as a
representative BCFfish value. The Biomagnification value (BMF) is typically determined based on a
measured BCFfish value; if such a value is unavailable, the log Kow should be used. Default BMF values for
organic substances are presented in the table below.
Table 2.7.2.6-1 Default BMF values for organic substances; souce: TGD (European Commission,
2003)
log Kow of substance BCF (fish) BMF
<4.5 < 2,000 1
4.5 - <5 2,000-5,000 2
5–8 > 5,000 10
>8 – 9 2,000-5,000 3
>9 < 2,000 1
Based on the measured BCFfish, a BMF of 1 would be suitable, however, as a worst case, a BMF value of
2 has been used.
The TGD specifies that it would be unrealistic to consider that the totality of an animal diet would be
sourced from the release area. Therefore, it is recommended to consider that 50% of the diet comes from
an area impacted by local release of deltamethrin (referred to as the “local area”) and the remaining diet
would come from an area where regional background concentration can be expected (referred to as the
“regional area”). In this risk assessment, it is considered that use of the product does not significantly
contribute to environmental concentrations at the regional scale.
Calculation of the PECoral predator for the aquatic compartment was carried out according to the TGD and
includes consideration that 50% of the predator’s diet is sourced locally, as follows:
PEC oral , predator ( fish ) = 0.5 × PEC water × BCF fish × BMF
Where:
Variable/parameter (unit) Symbol Unit Value Source
Predicted environmental concentration in water PECwater [mg.L-1] - Input
Bioconcentration factor for fish on wet weight basis BCFfish [l kg wet fish-1] 1400 Input
Biomagnification factor in fish BMF [-] 2 Input
Page 104 of 142

Predicted environmental concentration in food PECoral, predator (fish) [mg kgwet fish-1] - Output
Diet sourced from the terrestrial compartment
An estimated BCF value for earthworms of 483 L.kg wet earthworm-1 was used for the purpose of the risk
assessment, calculated using a Kow value of 40200 and the calculation method presented in the TGD, as
shown below:
(0.84 + 0.012 × Kow)

BCFearthworm =
RHOearthworm
Where:
Earthworm density RHOearthworm [kgwwt.L-1] 1 Default
Octanol-water partition coefficient Kow [-] 40200 Input
Bioconcentration factor for earthworms on
BCFearthworm [L.kgwet earthworm-1] - Output
wet weight basis
Calculation of the predicted environmental concentration in food for terrestrial predators has been
calculated using the following equations, from the TGD:
BCFearthworm × C porewater × Wearthworm + C soil × W gut

C earthworm =
Wearthworm + W gut
With:
RHOsoil
CONVsoil =
Fsolid × RHOsolid
The calculation of the concentration in earthworms can be rewritten using the following equation:
W gut = Wearthworm × Fgut × CONV soil
Where:
Page 105 of 142

Bioconcentration factor for earthworms on
BCFearthworm [L.kgwet earthworm-1] 483 Input
wet weight basis
Concentration in porewater Cporewater [mg.L-1] - Input
Weight of earthworm tissue Wearthworm [kgwwt tissue] - Input
Concentration in soil Csoil [mg.kgwwt-1] - Input
Weight of gut contents Wgut [kgwwt] - Input
Fraction of gut loading in worm Fgut [kgdwt kgwwt-1] 0.1 Default
Conversion factor for soil concentration
CONVsoil [kgwwt.kgdwt-1] - Calculated
wet-dry weight soil
Bulk density of wet soil RHOsoil [kgwwt.m-3] 1700 Default
Volume fraction of solids in soil Fsolid [m3 m-3] 0.6 Default
Density of solid phase RHOsolid [kgdwt m-3] 2500 Default
Concentration in earthworm on wet weight
Cearthworm [mg.kgwet earthworm -1] - Output
basis
Therefore, the resulting calculation is described by the equation below:
BCFearthworm × C porewater + C soil × Fgut × CONV soil

C earthworm =
1 + Fgut × CONVsoil
As for the aquatic food chain, the TGD specifies that it would be unrealistic to consider that the totality of
an animal diet would be sourced from the release area for the terrestrial compartment. Therefore, it is
recommended to consider that 50% of the diet comes from an area impacted by local release of
deltamethrin (referred to as the “local area”) and the remaining diet would come from an area where
regional background concentration can be expected (referred to as the “regional area”). In this risk
assessment, it is considered that use of the product would not significantly contribute to environmental
concentrations at the regional scale. Therefore, the following equation applies:
PEC oral , predator (earthworm) = 0.5 × C earthworm
The TGD specifies that, for the assessment of biomagnification effects resulting from indirect soil
exposure (i.e. sludge application to land), a time-weighted average period of 180 days can be used.
Predicted environmental concentrations in the agricultural soil compartment section 2.7.2.5, which
represents the worst-case compartment for the 180-day time period, were therefore used to assess
secondary poisoning for the case that deltamethrin reaches soil via sludge application.
Summary of predicted environmental concentrations of deltamethrin in predator diets
Estimated concentrations of deltamethrin in predator diets, for consideration of the risk of secondary
poisoning, are presented in the table below.
Page 106 of 142

Sensitisation
The potential for K-Othrine SC 25 to elicit a specific sensitisation response was assessed in mice
according to a Local Lymph Node Assay according to the OECD guideline 429. Based on this data K-
Othrine SC 25 is not a skin sensitizer, and does not require EU classification regarding sensitisation.
Other
The biocidal product, Deltamethrin SC 25-SC 26.25 contains deltamethrin (25 or 26.25 g/l), together with
co-formulants. The toxicity of the active substance has been documented in Document III-A. Information
on the toxicology of the other components of the product was provided based on the corresponding
Material Safety Data Sheets. As the composition of the formulation is confidential, information on the
formulants is also confidential as it would allow conclusions concerning the composition of the product.
However, no additionally toxicological concerns are raised by the co-formulants according to the Material
Safety Data Sheets for which additionally toxicity testing would be required.
Page 111 of 142

Handling
No specific precautions required when handling unopened packs/containers; follow relevant manual
handling advice.
Storage
Requirements for storage areas and containers. Keep containers tightly closed in a dry, cool and well-
ventilated place. Store in original container. Store in a place accessible by authorized persons only. Keep
away from direct sunlight. Protect from freeze.
Advice on common storage: Keep away from food, drink and animal feedingstuffs.
Stable under normal storage conditions.
No hazardous reactions when stored/handled in accordance with label instructions.
Transport:
According to national and international transport regulations not classified as dangerous goods.
UN number: 3077
Proper shipping name:
ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. (DELTAMETHRIN
MIXTURE)
Transport hazard class(es): 9
Packing group: III
Environm. Hazardous Mark: YES
ADR/RID/AND: Hazard no.: 90; Tunnel code: E

IMDG: Marine pollutant: YES; IMDG SEGREGATION GROUP 18 -
ALKALIS
IATA: As above
Fire-fighting measures
In the event of fire dangerous gases can be released.
In the event of fire and/or explosion do not breathe fumes.
Use self-contained breathing apparatus for fire fighting.
Extinguishing media: water spray, carbon dioxide (CO2), dry powder, foam
Contain the spread of the fire-fighting media.
High volume water jet is unsuitable for extinguishing/controlling fire
First-aid measures:
Page 134 of 142

General Remove contaminated clothing immediately and dispose of safely.
Inhalation: Move the patient to fresh air and keep at rest. Call a physician or poison control centre
immediately
Ingestion: Call a physician or poison control centre immediately. Rinse mouth. Do NOT induce
vomiting.
Skin Wash off thoroughly with plenty of soap and water for approximately 15 minutes.
contact: Warm water may increase the subjective severity of the irritation/paresthesia. This is
not a sign of systemic poisoning. In case of skin irritation, application of oils or lotions
may be considered.
Call a physician if irritation develops and persists.
Eye contact: Rinse immediately with plenty of water, also under the eyelids, for at least 15 minutes.
Warm water may increase the subjective severity of the irritation/paresthesia. This is
not a sign of systemic poisoning.
Apply soothing or anaesthetic eye drops if needed. Call a physician if irritation
develops and persists.
Notes to Treat symptomatically.
physician: Monitor: respiratory and cardiac functions.
In case of ingestion gastric lavage should be considered in cases of significant
ingestions only within the first 2 hours. However, the application of activated charcoal
and sodium sulphate is always advisable.
Keep respiratory tract clear.
Oxygen or artificial respiration if needed.
In case of convulsions, a benzodiazepine (e.g. diazepam) should be given according to
standard regimens. If not effective, phenobarbital may be used.
Contraindication: atropine.
Contraindication: derivatives of adrenaline.
There is no specific antidote.
Accidental release measures

Personal precautions
Avoid contact with spilled product or contaminated surfaces.
Wear personal protective equipment.
Unprotected persons must be kept away.
Environmental Precautions
Do not allow to get into surface water, drains and ground water.
Page 135 of 142

Methods for cleaning up
For decontamination measures following accidental release follow recommended methods and precautions
concerning handling, use, storage, transport or fire.
Clean contaminated floors and objects thoroughly, observing environmental regulations.
Keep in suitable, closed containers for disposal.
Disposal Considerations
Collect and dispose of the damaged packaging and contaminated materials according to the current
regulations.
In accordance with current regulations and, if necessary, after consultation with the site operator and/or
with the responsible authority, the product may be taken to a waste disposal site or incineration plant.
Contaminated packaging: Not completely emptied packaging should be disposed of as hazardous waste.
Page 136 of 142

3 PROPOSAL FOR DECISION
BACKGROUND TO THE DECISION
3.1.1 General background

The application was submitted as a frame formulation under Directive 98/8/EC and was subsequently
transformed to an application for biocidal product family with two family members (products) in
accordance with the Biocidal Products Regulation (EU) No 528/2012 and the transitional measures in
Article 91. The two family members, K-Othrine SC 25 and K-Othrine SC 26.25, differ in their content of
the active ingredient, deltamethrin (2.46 and 2.56 % w/w, respectively), and there is also a variation in the
concentration of non-active substances. See confidential annex for details.
3.1.2 From the Assessment Report

The active substance, deltamethrin, was 2013-10-01 included as an active substance in Annex I to
directive 98/8/EC. Sweden was the Rapporteur Member State (RMS). According to the Assessment
Report, the following specific provisions apply:
-The active substance, deltamethrin, as manufactured, shall have a minimum purity of ≥ 98.5% w/w.
- In view of the risks identified for aquatic ecosystems for the indoor barrier treatments in domestic/larger
buildings (resulting in emissions to STP), products shall not be authorised for this use unless it can be
demonstrated that the product will meet the requirements of Article 5 and Annex VI, if necessary by the
application of risk mitigation measures.
- When assessing the application for authorisation of a product in accordance with Article 5 and Annex
VI, Member States shall assess, where relevant for the particular product, the populations and
environmental compartments that may be exposed to the product and use or exposure scenarios that have
not been representatively addressed at the Union level risk assessment.
All the specific provisions do apply.
3.1.3 Previous use and authorisation in Sweden

In Sweden the product K-Othrine SC 25 has been authorised since 2007.
3.1.4 Conclusions from efficacy and risk assessment of the product family
It is concluded that the risks associated with physico-chemical properties of the K-Othrine SC 25 Family,
such as flammability, explosivity and thermal stability, are low.
The efficacy of the product family for treatment of crawling insects and flies at rest in indoor situations
(6.25 (6.56) -12.5 (13.3) mg/m2), when used according to instructions in the SPFC, is considered
acceptable. However, strategies for managing the development of resistance should be considered.
Therefore information on the SDS about IRAC classification and information on principles to avoid the
development of resistance is recommended
It is concluded from the health risk assessment of the K-Othrine SC 25 Family that the intended use of the
product would not pose unacceptable risk to human health. The health risk assessment does not include
direct exposure via food or feedstuff, nor does it include the risk assessment of exposed pets. Instead, this
will be handled with risk mitigation measures. The product is proposed to be labelled with the sentence
“The product should be applied so that pets, food or feedstuffs do not come in contact with the product.”
It is concluded from the environmental risk assessment of the K-Othrine SC 25 Family that the intended
use of the products, with one exception of usage, would not pose unacceptable risks to the environment.
Page 137 of 142

Using the K-Othrine SC 25 Family for indoor barrier treatment in areas subject to wet cleaning leads to
unacceptable risks for aquatic and groundwater compartments and the products shall not be authorised for
this use. The indoor crack & crevice treatment in areas subject to wet cleaning is acceptable if the spray
bandwidth is limited to max 0.1 m. Application in areas not subject to wet cleaning are considered
acceptable.
PROPOSAL FOR DECISION

On basis of the Assessment Report of the active substance and the Product Assessment Report, the
opinion of Ref-MS Sweden is to authorise the K-Othrine SC 25 Family and the products in this family, to
be used as biocide products. The conditions are outlined in the Summary of biocidal Product Family
Characteristics (SPFC), were both the products K-Othrine SC 25 and K-Othrine SC 26.25 are included in
one meta-SPC (second information level of the SPFC).
Page 138 of 142

ANNEX 1: REFERENCE LIST
Author(s) Section No / Year Title. Source (where different from Data Owner
Reference company) Company, Report No. Protection
No GLP (where relevant) / Claimed
(Un)Published (Yes/No)
Amir 2.4 2015a Product Composition for Deltamethrin No Bayer

Tahmasseb, SC 25 g/L Crop-
L. Science
102000017408-03
UVP 79112947
Bayer S.A.S.,
Edition Number: M-415634-03-7
Date: 2015-07-07
Non GLP, unpublished
CONFIDENTIAL
Amir 2.4 2015b Product Composition for Deltamethrin No Bayer
Tahmasseb, SC 26.25 g/L Crop-
L. Science
102000012399-02
UVP 06520596
Bayer S.A.S.,
Date: 2015-07-07
CONFIDENTIAL
Amir 2.4 2015c Bridging statement explaining the No Bayer
Tahmasseb, change in the recipe of the product K- Crop-
L. Othrine SC 25 Suspension Science
Concentrate (SC) containing:
Lasserre, D.
Deltamethrin 26.25 g/L
From UVP 06520596
To UVP 79112947
Bayer S.A.S.
Date: 2015-07-27
CONFIDENTIAL
Page 139 of 142

Product Assessment Report - K-Othrine SC 25 Family Public

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REPORT

Product Assessment Report of a Biocidal Product Family

Products (trade names):

Type of application Product type

Authorisation number for the biocidal products Date of expiry

K-Othrine SC 25 (5327-1-1) 28 June 2027

K-Othrine SC 26.25 (5327-1-2)

Deltamethrin, 2.43-2.52 % (w/w) Class 2 - Products for

1 GENERAL INFORMATION ABOUT THE PRODUCT FAMILY APPLICATION 5

Current authorisation holder 5

Proposed authorisation holder 6

Information about the product family application 6

Information about the biocidal product family 7

2 SUMMARY OF THE PRODUCT FAMILY ASSESSMENT 12

Information to the reader from the Ref-MS 12

Identity related issues 12

Classification, labelling and packaging 12

Analytical methods for detection and identification 19

Effects assessment 108

HAZARD IDENTIFICATION FOR PHYSICO-CHEMICAL PROPERTIES 112

RISK CHARACTERISATION FOR HUMAN HEALTH 113

RISK CHARACTERISATION FOR THE ENVIRONMENT 118

RISK CHARACTERISATION FOR THE PHYSICO-CHEMICAL PROPERTIES 133

MEASURES TO PROTECT MAN, ANIMAL AND THE ENVIRONMENT 133

3 PROPOSAL FOR DECISION 137

Background to the decision 137

Proposal for decision 138

ANNEX 1: REFERENCE LIST 139

Company Name: Bayer S.A.S.

Address: 16 rue Jean-Marie Leclair CS 90106

City: Lyon Cedex 09

Postal Code: F-69266

1.1.1 Person authorised for communication on behalf of the applicant

Address: 16 rue Jean-Marie Leclair, CS 90106

Postal Code: F-69266 Cedex 09

CURRENT AUTHORISATION HOLDER

Company Name: Bayer AB

Address: Arne Jacobsens Allé 13

Postal Code: 2300

Letter of appointment for the Not applicable

INFORMATION ABOUT THE BIOCIDAL PRODUCT FAMILY

1.5.1 General information

Family name: K-Othrine SC 25 Family

Meta (second information level): K-Othrine SC 25-1

Individual products trade names (third K-Othrine SC 25

Manufacturer’s development code number(s), if K-Othrine SC 25 (25 g/L):

Product type: PT18

Formulation type: Suspension Concentrate (SC)

Ready to use product (yes/no): No

1.5.2 Information on the intended use(s)

Uses claimed by the applicant

Category of users: Professionals

Potential for contamination of food/feedingstuff No.

Use Restrictions: Detailed on proposed label

Uses authorised by the Reference Member State

2. Spray indoors for control of localised infestations of

3. Spray indoors for control of flies when at rest, in

Category of users: Professional and trained professional users

Active substance chemical name: Deltamethrin

CAS No: 52918-63-5

Purity (minimum, g/kg or g/l): 98.5 %w/w

Inclusion directive: Commission Directive 2011/81/EU

Date of inclusion: October 1st, 2013