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Bijlage i, bij het besluit d

HET COLLEGE VOOR DE TOELATING VAN GEWASBESCHERMINGSMIDDELEN EN
BIOCIDEN
BIJLAGE II
bij het besluit d.d. 15 maart 2013 tot toelating van het middel Embalan
Houtwormdood 10, toelatingnummer 14016 N


RISKMANAGEMENT
Contents
1. Introduction

This assessment concerns the biocidal product Embalan Houtwormdood 10 based on the
active substance permethrin. This application has previously been submitted under the
differentiated enforcement policy of biocides. The current evaluation includes the
additional information for further refinement.
The assessment includes the fol owing product:
Product
Applicant
Application number
Embalan Houtwormdood 10 Hoetmer b.v. PT 8 The active substance Permethrin has been notified for product types PT 8, PT 9 and PT 18. Permethrin has not been placed on annex 1 of Directive 98/8/EC yet. 2. Identity

Identity of the active substance permethrin

Identity
3-phenoxybenzyl(1RS)-cis,trans-3-(2,2-dichlorovinyl)-2,2-dimethylcyclopropanecarboxylate Cyclopropanecarboxylic acid, 3-(2,2-dichloroethenyl)-2,2-dimethyl-,(3-phenoxyphenyl)methyl ester The active substance permethrin is not yet included in annex I of Directive 98/8/EC. A CAR of the active substance is available (RMS: Ireland). Physical and chemical properties of the active substance permethrin

Physical and chemical properties relevant to the risk assessment

cis- isomer @ 25°C 2.88 µPa (99.7%) trans- isomer @ 25°C 0.92 µPa (99.6%) <4.95 µg l-1 (<0.00495 mg/l) at 20°C Permethrin does not dissociate in an environmental y relevant pH range. UV/VIS absorption (max.) (if absorption >
Hazard identification for classification and labelling
Flashpoint: > 55 °C Flammability: Not highly flammable Auto-flammability: > 400 °C
Analytical methods for the technical active substance permethrin
Adequate analytical methodology is available to determine the content of active
substance and significant and/or relevant impurities in the technical active substance.
Conclusions active substance permethrin
The identity, physical and chemical properties and analytical methods of the active
substance are sufficiently described.
3. Physical and chemical properties

Identity of the biocidal product Embalan Houtwormdood 10
Name

Physical and chemical properties of the biocidal product Embalan Houtwormdood
10

Colourless to light yel ow homogeneous liquid. Physical and chemical compatibility Not applicable Viscosity
Analytical methods for detection and identification
Analytical methods for analysis of the biocidal product Embalan Houtwormdood 10
Preparation (principle of method)

3.3.2 Residue analytical methods
Adequate residue analytical methodology is available to monitor residues of the biocide
taking into account al possible exposure scenarios and the toxicity of the active
substances.
3.4
Conclusions biocidal product
The identity, the physical and chemical properties and the analytical methods of the biocidal product are sufficiently described. 4. Efficacy
Function
Embalan Houtwormdood 10 is an insecticide used as wood preservative with the active
substance permethrin (0.25%w/w ).
Field of use envisaged
The proposed field of use of the product Embalan Houtwormdood 10 is the control of
insects in wood (both curative and preventive). This use belongs to use class 1 and 2.
This use is included in PT08. The product is intended for non-professional use only.

Mode of action
Permethrin is a pyrethoid. The principal effect of this group of active substances is to
delay sodium channel closure on nerve axons, what in turn delays membrane
repolarisation fol owing an action potential. This leads to spontaneous repetitive nerve
firing and convulsions.
The visible symptoms of pyrethroid poisoning are typical y a lack of co-ordination of
movements and normal behaviour (often termed the "knockdown or kd effect"), the
appearance of convulsive activity, regurgitation of alimentary canal contents, and
ultimately paralysis and death. Symptoms which inhibit feeding and movement occur
within minutes of dosing, but death due to dehydration and other secondary effects may
take up to 24 hours.
Resistance
No resistance against permethrin was reported. Considering that the authorisation is
done under article 121 of the WGB this is acceptable.
Conclusions
Considering that the evaluation is done under article 121 of the WGB and that the product
has already been on the market for some time, it can be concluded that Embalan
Houtwormdood 10, when used in accordance with the proposed label (WG/GA), may be
expected to be effective in control ing of insects in wood (both curative and preventive).
5. Human toxicology
5.1

Human health effects assessment active substance
Permethrin is an existing active substance, not included in Annex I of 98/8/EG. An application for inclusion is submitted. This assessment is based on the endpoints given below. The first and revised draft concept CA-report (2006 and 2010) for which Ireland is
the Reporting Member State, is stil in the process of evaluation/discussion, the
toxicological profile in the CAR should be regarded as provisional.
List of Endpoints
In 2007 several reviews were made by Ctgb for products based on permethrin. The
fol owing endpoints were derived from the assessments made in 2007 and from
C.140.3.23.
A (semi)-chronic AOEL of 0.08 mg/kg bw/day was derived, based on an overal NOAEL of
5 mg/kg bw/day from semichronic and chronic toxicity studies in rats, an oral absorption
of 60% and a total assessment factor of 36 (4x3x3). Based on a body weight of 60 kg for
non-professionals, this results in a AOEL of 4.8 mg/day.
A (sub)-acute AOEL of 0.63 mg/kg bw/day was derived, based on an overal NOAEL of
38 mg/kg bw/day from a 28-day oral neurotoxicity study in rats, an oral absorption of 60%
and a total assessment factor of 36 (4x3x3). Based on a body weight of 60 kg for non-
professionals, this results in an AOEL of 38 mg/day.
Based on the NOAEL of 38 mg/kg bw, an overal assessment factor of 100 and a body
weight of 10 kg, an ARfD for children of 3.8 mg/day is calculated.
A dermal absorption of 5% is assumed, based on the assessments made in 2007.
Local effects
Permethrin is a pyrethroid. Pyrethroids produces very slight and reversible paresthesia
(itching or tingling sensation), which is probably the result of local irritation of the
peripheral nerves. This effect is discussed in the EU (Working group “classification and
label ing”) and based on the outcome of the discussion al pyrethroids, including
permethrin, are assigned with the fol owing S-phrase: S24 “Avoid contact with skin” or
P262 “Do not get in eyes, on skin, or on clothing” is assigned.

Data requirements active substance
No additional data requirements are identified.

Human exposure assessment active substance

5.2.1
General aspects
Embalan Houtwormdood 10 is a liquid and contains the active substance permethrin (2 g/L). The proposed field of use is:
An application is done for non-professional use only.
An assessment of uses and exposure scenarios was made for the products. A summary
of uses is given in Table T.1 below.
Table T.1
Summary of uses
Application
Potential
centration
concentration
secondary
exposure
Application
Potential
centration
concentration
secondary
exposure
Identification of main paths of professional exposure towards active
substance from its use in biocidal product
The product is intended for non-professionals only.
5.2.3
Identification of main paths of non-professional exposure towards active
substance from its use in biocidal product
For low pressure spraying by a knapsack sprayer, spraying model 1 of the TNsG can be
used. The data of the model include exposure during mixing and loading.
For brushing the antifouling model for brushing paint can be used for the estimated for
dermal and respiratory exposure to Permethrin.
For application through by injection with a syringe, exposure is considered equivalent or
less than application through low pressure spraying and brushing. Therefore, no separate
exposure assessment was made for this application.
For non-professional users, a subacute exposure duration is assumed, as application wil
occur once or twice a year.
5.2.4
Indirect exposure as a result of use of the active substance in biocidal
Re-entry exposure in treated rooms should be considered. Intensive dermal contact with
the treated wooden surface is not to be expected and will only be incidental.
Based on the vapour pressure of Permethrin (2.5 µPa), respiratory exposure to
Permethrin after use is not to be expected.
Secondary inhalation exposure might occur through cutting or sanding of wood. In the
CAR of Permethrin, a calculation is made on the exposure for this scenario, and this
calculation of considered for both products under consideration.
Exposure of children cannot be excluded by use of the product in wood such as sealings
and floors, but also furniture and antique wooden objects. Therefore, the oral and dermal
exposure of children wil also be calculated. The calculation as included in the CAR of
permethrin wil be considered for this purpose. Although, treatment of childrens toys and
childrens furniture is not considered a relevant scenario, as a worst-case the oral
exposure of infants chewing on treated wood is considered.
5.3
Human health effects assessment product
Toxicity of the formulated product
No studies with Embalan Houtwormdood have been submitted and the classification and
label ing of the formulation has been prepared based on the calculation method described
in Annex I of Regulation 1272/2008/EC.
5.3.2
Data requirements formulated product
No additional data requirements are identified. Risk characterisation for human health
Professional users
No professional use was considered in the application.
5.4.2
Non-professional users, including the general public
For low pressure spraying by a knapsack sprayer, spraying model 1 of the TNsG can be used. The data of the model include exposure during mixing and loading. If the products are applied by a trigger spraying, the spraying model 1 is considered worst-case. For brushing the antifouling model for brushing paint can be used for the estimated for dermal and respiratory exposure to permethrin. For brushing an exposure duration of 2 hours is assumed. Considering the vapour pressure of permethrin (2.5 µPa) during brushing is considered negligible. The formulations has an in-use concentration of 2 g/L. For application through by injection with a syringe, exposure is considered equivalent or less than application through low pressure spraying and brushing. Therefore, no separate exposure assessment was made for this application. Table T.2 Internal non-professional operator exposure to permethrin and risk assessment for the use of Embalan Houtwormdood 10 without PPE Internal exposure was calculated with: biological availability via the dermal route: 5 % biological availability via the respiratory route: 100% (worst case) The risk-index is calculated by dividing the internal exposure by the systemic AEL. Exposure is estimated with spraying model 1 of TnsG 2002.
On the basis of the above considerations, it can be concluded that the risk for the non-
professional user of Embalan Houtwormdood 10 is acceptable.
5.4.3
Indirect exposure as a result of use
Re-entry exposure in treated rooms should be considered. Based on the vapour pressure of Permethrin (2.5 µPa), respiratory exposure to Permethrin after use is not to be expected. Proper ventilation should be considered for the products after application. An assumption of an surface loading of 0.5 g a.s./m2 was made. However, based on an evaluation of the PGB, the maximum loading rate should be 0.35 g/m2. However, the calculations were made with the value of 0.5 g a.s./m2 and are considered worst-case. Secondary inhalation exposure might occur through cutting or sanding of wood. In the CAR of Permethrin, a calculation is made on the exposure for this scenario, and this calculation of considered for both products under consideration. For this scenario, the fol owing is assumed: • Surface loading is 0.5 g a.s./m2 for both products (0.05 mg/cm2). The product is evenly distributed in the outer 1 mm zone of the wood, in effect the surface for sprayed or brushed woodpreservatives. • Material: 4 cm x 4 cm x 2.5 m treated post (0.004 m3 wood). • Task: hand held power sanding of surface. • Exposure: 5 mg/m3 for 60 minutes (occupational exposure limit for wood dust) • Density of timber: 0.4 g/cm3 (agreed in TMIII08) Based on the assumptions above the fol owing calculation can be made: Inhalation exposure: 5 mg/m3 x 1 hour/day x 1.25 m3/hour = 6.25 mg wood dust (0.00625 g) that a wood density of 0.4 g/m3 is equivalent to 0.00625 / 0.4 = 0.015625 cm3 wood (15.625 mm3). At a thickness of 1 mm this equates to a surface area of √ 15.625= 3.95 mm x 3.95 mm = 0.156 cm2. (Calculation in accordance with first draft CAR Permethrin) At 0.05 mg/cm2, then 0.156 cm2 contains 0.05 x 0.156 = 0.0078 mg The inhalation exposure is calculated to be 0.0078 mg/day. With an inhalation absorption of 100%, this results in an internal exposure of 0.0078 mg/day. Intensive dermal contact with the wet treated wooden surface is not to be expected and wil only be incidental. A calculation is made for the handling of treated wood for sanding, based on the fol owing assumptions: • Surface loading is 0.5 g a.s./m2 (0.05 mg/cm2). The product is evenly distributed in the outer 1 mm zone of the wood, in effect the surface for sprayed or brushed woodpreservatives. • Task: hand held power sanding of surface. • Transfer coefficient: 20% (TNsG on Human exposure, part 2, page 204) Based on the assumptions above the fol owing calculation can be made: Dermal exposure: 0.05 mg/m2 x 84 cm2 x 0.2 = 0.84 mg The external dermal exposure is calculated to be 0.84 mg/day. With a dermal absorption of 5%, this results in an internal exposure of 0.042 mg/day. Exposure of children cannot be excluded by use of the product in wood such as sealings and floors, but also furniture and anique wooden objects. Therefore, the dermal exposure of children crawling on treated floors wil also be calculated, based on the fol owing assumptions: • Surface loading is 0.5 g a.s./m2 for both products (0.05 mg/cm2). The product is evenly distributed in the outer 1 mm zone of the wood, in effect the surface for sprayed or brushed wood preservatives. • Exposure surface area: 200 cm2 (hand) Based on the assumptions above the fol owing calculation can be made: Dermal exposure: 0.05 mg/m2 x 40 cm2 x 0.2 = 0.4 mg The external dermal exposure is calculated to be 0.4 mg/day. With a dermal absorption of 5%, this results in an internal exposure of 0.02 mg/day. As treatment of children’s toys and furniture is not considered a relevant scenario, however, as a worst-case a calculation was made on the oral exposure of infants chewing treated wood based on the fol owing assumptions: • Surface loading is 0.5 g a.s./m2 for both products (0.05 mg/cm2). The product is evenly distributed in the outer 1 mm zone of the wood, in effect the surface for sprayed or brushed wood preservatives. • Task: chewing 4 cm x 4 cm x 1 cm piece, with surface area of 48 cm2 • Transfer coefficient: 100%, extracting 100% of wood preservative contained on Oral exposure is calculated to be 48 * 0.05 = 2.4 mg/day Table T.3 Internal secondary exposure to permethrin and risk assessment for the use of Embalan Houtwormdood en Luxan Houtinsecticide-P NW without PPE Internal exposure was calculated with: biological availability via the dermal route: 5 % biological availability via the respiratory route: 100% (worst case) The risk-index is calculated by dividing the internal exposure by the systemic AEL. Exposure is calculated using CARs of PT8 and TNsG, part 2, 2002.
Based on the risk assessment, it can be concluded that no adverse health effects are
expected by indirect exposure to permethrin as a result of the application of Embalan
Houtwormdood.
5.4.4
Combined exposure
Embalan Houtwormdood 10 contains only one active substance and it is not described
that it should be used in combination with other formulations.
5.5
Overall conclusions for the aspect human health
For the unprotected non-professional, no adverse health effects are expected after exposure to Permethrin as a result of manual spraying or brushing of Embalan Houtwormdood 10. A safe use can be concluded for indirect exposure of workers sanding treated wood. In addition, a safe use for oral (chewing on treated wood) and dermal (crawling on treated wood) exposure of children can be concluded after use of Embalan Houtwormdood 10. 6. Environment

6.1 Introduction
Authorisation is requested for the product Embalan Houtwormdood 10 containing as
active substance permethrin. The biocidal product concerns a wood preservative (PT8)
for the treatment of wood for non-professional use indoors.
The intended use is described in table E.1.

Table E.1.

Intended use
Application
Dilution
product concentratio
n (g a.s./m2)

The risk for the environment are assessed by using the Emission Scenario Documents
(ESDs) for wood preservatives (OECD) and the TGD (2002).
6.2 Product related studies
The exposure assessment is based on data for the active substance. There are no fate or
ecotoxicity data available for the product.
6.3 Environmental exposure assessment product
Chemistry and/or metabolism
Permethrin was observed to be hydrolytical y stable and direct photolysis of permethrin
indicated slow degradation of test material fol owing irradiation equivalent to Florida
autumn sunlight. Permethrin was observed not to be readily biodegradable fol owing
investigation using test guideline OECD 301F.
Degradation-only DT50 values for permethrin in freshwater systems are available from
laboratory water-sediment studies but pertain to the whole system (water and sediment
combined). Whole-system first order DT50 values in laboratory aerobic water-sediment
tests were 63.7 days for cis-permethrin (25 ºC), 27.3 days for trans-permethrin (25 ºC)
and 14.3 to 24.6 days for 25:75 cis:trans permethrin (20 ºC). Under anaerobic laboratory
test conditions, whole-system first order DT50 values were 179.4 days for cis-permethrin
(25 ºC) and 114.5 days for trans-permethrin (25 ºC).
Permethrin is not expected to enter into the atmosphere in large amounts owing to the
low vapour pressure and Henry’s Law constant. Based on studies of the fate and
behaviour of permethrin, the distribution of permethrin amongst the various environmental
compartments is likely to be concentrated in soil and sediment (fol owing entry into
surface water)
The major degradation products observed fol owing the metabolism of permethrin in soil
were DCVA and PBA.
Distribution in the environment
Various phases in the life cycle of a product may cause emissions and environmental
exposure. In the risk assessment, emissions from the application phase, service life and
waste phase of the product are considered. Emissions from active substance production
and product formulation are not part of the risk assessment. Table E.3 summarises the
receiving environmental compartments that have been identified as potential y exposed
during the application and in service life phase of the product for the different
applications.
Table E.3.
Foreseeable routes of entry into the environment on the basis of the
intended use.
Environmental compartments and groups of organisms
exposed

Use scenario
STP Freshwater* Saltwater* Soil** Air
Birds and
mammals

indoor treatment of wood and treated products by brushing/spraying/injection (use classes 1&2)1 ++ Compartment potential y exposed (but unlikely significant concern due to a.s. hazard data and scale The compartment is potentially exposed or not. This depends on the specific use and the characteristics of the active substance Including groundwater, bees and non-target arthropods In the Netherlands, surplus sludge of public STPs is not applied for fertilization and soil improvement of agricultural soil. Therefore, exposure of soil and groundwater via STP surplus sludge application is not part of the risk assessment. 1 Use class 1: Situation in which wood or wood-based product is under cover, fully protected from the weather and not exposed to wetting. Use class 2: Situation in which wood or wood-based product is under cover, fully protected from the weather but where high environmental humidity can lead to occasional but not persistent wetting 3 For indoor treatments by spraying, brushing and injection, no scenario is proposed in the ESD because the
emissions to the environment, during these treatments and from treated wood after the treatments, are
considered to be negligible. The exposure and risk for aquatic organisms and micro-organisms in the STP is
mitigated by inclusion of restriction sentences in the proposed label (WGGA).
For indoor treatments by spraying, brushing and injection, no scenario is proposed in the
ESD because the emissions to the environment, during these treatments and from
treated wood after the treatments, are considered to be negligible.
PEC in surface water, sediment and STP
No (in)direct exposure of surface water and sediment is expected from indoor application
of the product or of treated wood in case treatment of wood takes place indoors or under
roof.
However, spil s and residues containing the product can be discharged to the STP, for
example after cleaning of materials used for application of the product onto wood e.g.
brushes. The fol owing restriction sentences are therefore included in the proposed label
(WGGA):
• To protect water living organisms, run-off to soil or surface water needs to be prevented. Therefore treatment with this product needs to take place indoors or under roof. Alternatively, during treatment the soil underneath and around the object to be treated needs to be covered with plastic. [Om bodem- en in water levende organismen te beschermen moet afstroming naar bodem of oppervlaktewater worden voorkomen. Hiertoe dient de behandeling met dit middel plaats te vinden binnenshuis of onderdak danwel dient de bodem onder en rondom het te behandelen object te worden afgeschermd met plastic]. • Discharge of leftover and residues containing the product (e.g. solvents or water used for cleaning of brushes or syringes) to the sewer or surface water is not permitted. leftover and residues containing the product (e.g. solvents or water used for cleaning of brushes or syringes) need to be removed as chemical waste. [Overschotten van dit middel en de resten hiervan (zoals oplosmiddel of water gebruikt voor reiniging van kwasten, spuiten e.d.) niet lozen in het riool of naar oppervlaktewater, maar deze hergebruiken of verwijderen als chemisch afval].
PEC in air
See section air under risk characterisation for the environment.
PEC in soil and groundwater
No (in)direct exposure of soil and groundwater is expected from indoor application of the
product or of treated wood in case treatment of wood takes place indoors or under roof.
The fol owing restriction sentences are therefore included in the proposed label (WGGA):
• To protect water living organisms, run-off to soil or surface water needs to be prevented. Therefore treatment with this product needs to take place indoors or under roof. Alternatively, during treatment the soil underneath and around the object to be treated needs to be covered with plastic. [Om bodem- en in water levende organismen te beschermen moet afstroming naar bodem of oppervlaktewater worden voorkomen. Hiertoe dient de behandeling met dit middel plaats te vinden binnenshuis of onderdak danwel dient de bodem onder en rondom het te behandelen object te worden afgeschermd met plastic].
Additional y the fol owing consideration is taken into account for the authorisation of this
product for non-professionals. When non-professionals are using a spayer for the
application of this product emission to soil and water cannot be prevented, even when a
plastic cover is used.
Furthermore the use of spray chambers is considered to be unrealistic for non-
professionals. Therefore the use of a sprayer must be removed from the label.
Primary and secondary poisoning of birds and mammals
The proposed use will not result in (in)direct exposure of birds and mammals to the
product or contaminated aquatic or terrestrial organisms in case treatment of wood takes
place indoors or under roof and when used in accordance with the proposed label
(WG/GA).However, indoor treatments are relevant for the exposure assessment of bats in
countries where bats are protected animals (e.g. in most European countries). Bats are
exposed to treated wood via contact.

6.4 PNEC derivation
Emission to the environment from the intended use is considered negligible. PNECs for
permethrin and its major metabolites in environmental compartments are therefore not
presented here as these are not required for the qualitative environmental risk
assessment performed.
6.5 Risk characterisation for the environment
Aquatic compartment (incl. sediment) and STP
The proposed application of the product wil not result in exposure of the aquatic
compartment and the STP in case treatment of wood takes place indoors or under roof
and when used in accordance with the proposed label (WG/GA).The risk for aquatic and
sediment dwel ing organisms and micro organisms in the STP is considered acceptable.
.
Monitoring data (surface water)
The Pesticide Atlas on internet (www.pesticidesatlas.nl) contains measured
concentrations of permethrin in Dutch surface water. No direct or indirect exposure of
surface water is expected from indoor application of the product and indoor/under roof in
service use of the treated wood and when used in accordance with the proposed label
(WG/GA). These monitoring data are therefore not relevant for the exposure assessment.
Surface water intended for the abstraction of drinking water
The proposed application of the product and indoor/under roof in service use of the
treated wood will not result in exposure of the aquatic compartment in case treatment of
wood takes place indoors or under roof and when used in accordance with the proposed
label (WG/GA). The risk for surface water intended for the abstraction of drinking water is
considered acceptable.
.
Atmosphere
Criteria for the examination of environmental risks to air are not specified by a numerical
standard. The present assessment of potential impacts on air quality, is aimed to
minimize the risk for stratospheric ozone depletion.
AOPwin calculates for permethrin a half life of 0.701 day in air (24hr day, 0.5E+06
OH/cm3). This calculated half life is below the trigger of < 2 days, permethrin is not listed
as ‘’control ed substance’ in Annex I of Regulation (EC) No 1005/2009 of the European
Parliament), the environmental risk to air is considered acceptable.
Terrestrial compartment
Soil organisms and non target arthropods (including bees)
The proposed application of the product and indoor/under roof in service use of the
treated wood will not result in exposure of the soil compartment in case treatment of wood
takes place indoors or under roof and when used in accordance with the proposed label
(WG/GA). The risk for soil organisms and non target arthropods (including bees) is
considered acceptable when used in accordance with the proposed label (WG/GA).
Groundwater
The proposed application of the product and indoor/under roof in service use of the
treated wood will not result in exposure of the groundwater compartment in case
treatment of wood takes place indoors or under roof and when used in accordance with
the proposed label (WG/GA). The risk for the groundwater is considered acceptable when
used in accordance with the proposed label (WG/GA).
Persistence in soil
The proposed application of the product and indoor/under roof in service use of the
treated wood will not result in exposure of soil in case treatment of wood takes place
indoors or under roof and when used in accordance with the proposed label (WG/GA).
The standards for persistence in soil are met when used in accordance with the proposed
label (WG/GA).
Non compartment specific effects relevant to the food chain
Bioconcentration
The Log Kow (measured values of 4.6 and 6.1 L/kg) and some estimated BCF values
(20700 L/kg for fish, 15108 L/kg and 23.8 L/kg for earthworms) would indicate that
permethrin has a strong potential to bioconcentrate fol owing uptake via water/porewater
(e.g. in fish/worms) and subsequently bioaccumulate through the food chain, resulting in
toxic concentrations in predatory birds or mammals ingesting biota containing the
chemical.
However, the most relevant study in this instance is a 28-day bioconcentration study in
fish, in which the measured BCF was only 570 L/kg. Both this study and a Chironomid
study with measured BCF values of 166 L/kg in water, 415 L/kg in sediment and 296 L/kg
in porewater showed that while permethrin does appear to accumulate rapidly in the
tissues of these aquatic organisms, depuration fol owing exposure cessation was also
rapid in both cases. Therefore, in vivo, any bioaccumulated permethrin residues will most
likely be readily eliminated from organisms.
These findings and conclusions are supported by information gleaned from the literature
who stated that BCFfish values ranging from 290 – 620 L/kg have been reported in
sheepshead minnows. Based on measured BCFfish and BCFchironomid values < 2000 L/kg it
is concluded that permethrin does not meet the B or vB screening criteria. Hence, the standards for bioaccumulation are met. Primary and secondary poisoning of birds and mammals For the proposed use of the active substance as wood preservative indoors indirect exposure of birds and mammals (other than bats) to the active substance or contaminated aquatic and terrestrial organisms is considered negligible. Thus the risk for
secondary poisoning of birds and mammals is considered acceptable.
Bats are directly exposed to treated wood via contact with the treated wood (i.e. beams).
In an acute toxicity study with bats a permethrin product was applied to the plywood lining
of a steel cage 6 weeks to 14 months before bats (Pipistrellus pipistrellus) were
introduced. The plywood was grooved to al ow bats to climb and hang. Negative
(solvent) controls were included in the experimental design. Wild caught bats (10 per
cage) were introduced and fed ad libitum. No obvious harm was caused to the bats
roosting for 16 to 22 weeks in cages lined with permethrin treated plywood.
As the active substance is considered not bioaccumulative, the risk for the primary
poisoning of birds and mammals (including bats) is considered acceptable. The proposed
application meets the standards for birds and mammals (including bats).

6.6 Measures to protect the environment (risk mitigation measures)
The current proposed label (WG/GA) of Embalan Houtwormdood 10 does not contain risk
mitigation measures for the environment. The fol owing risk mitigation measures for the
environment are therefore included in the WGGA:
• To protect water living organisms, run-off to soil or surface water needs to be prevented. Therefore treatment with this product needs to take place indoors or under roof. Alternatively, during treatment the soil underneath and around the object to be treated needs to be covered with plastic. [Om bodem- en in water levende organismen te beschermen moet afstroming naar bodem of oppervlaktewater worden voorkomen. Hiertoe dient de behandeling met dit middel plaats te vinden binnenshuis of onderdak danwel dient de bodem onder en rondom het te behandelen object te worden afgeschermd met plastic]. • Discharge of of leftover and residues containing the product (e.g. solvents or water used for cleaning of brushes or syringes) to the sewer or surface water is not permitted. leftover and residues containing the product (e.g. solvents or water used for cleaning of brushes or syringes) need to be removed as chemical waste. [Overschotten van dit middel en de resten hiervan (zoals oplosmiddel of water gebruikt voor reiniging van kwasten, spuiten e.d.) niet lozen in het riool of naar oppervlaktewater, maar deze hergebruiken of verwijderen als chemisch afval].
The applicant proposed a sprayer for the application of Embalan Houtwormdood 10.
Considering that for this type of use emission to soil and water cannot be prevented (even
when using a plastic cover), the spray application needs to be removed from the label.

6.7 Overall conclusion for the aspect environment
When the biocidal product Embalan Houtwormdood 10 containing permethrin is used in
compliance with the directions for use (WG/GA), it can be concluded that:
1. For the proposed application no exposure of the aquatic and sediment compartment is expected. Therefore the proposed application of the product Embalan Houtwormdood 10 meets the standards for aquatic and sediment organisms. 2. For the proposed application no exposure of the STP is expected. Therefore the proposed application of the product Embalan Houtwormdood 10 meets the standards for microorganisms in the STP. 3. For the proposed application no exposure of the aquatic and sediment compartment is expected. Therefore the proposed application of the product Embalan Houtwormdood 10 meets the standards for the production of drinking water from surface water. 4. For the proposed application no exposure of the groundwater compartment is expected. Therefore the proposed application of the product Embalan Houtwormdood 10 meets the standards for the production of drinking water from shal ow groundwater. 5. the proposed application of the product Embalan Houtwormdood 10 meets the 6. For the proposed application no exposure of the soil compartment is expected. Therefore the proposed application of the product Embalan Houtwormdood 10 meets the standards for persistence in soil. 7. For the proposed application no exposure of the soil compartment is expected. Therefore the proposed application of the product Embalan Houtwormdood 10 meets the standards for soil organisms. 8. The proposed application of the product Embalan Houtwormdood 10 meets the 9. the proposed application of the product Embalan Houtwormdood 10 meets the standards for primary and secondary poisoning of birds and mammals (including bats). 10. the proposed application of the product Embalan Houtwormdood 10 meets the risks for non-target arthropods including bees. Based on the available data, it can be concluded that Embalan Houtwormdood 10, when used in accordance with the proposed label (WG/GA) complies with the environmental standards and will not cause unacceptable effects on the environment. 7 Conclusion
The applicant has proven that Embalan Houtwormdood 10, under the proposed Legal
Conditions for Use and the Directions for Use (WG/GA), that no unacceptable risk is
expected to human health, the person who uses the product and the environment and is
expected to be effective in control ing of insects in wood (Art. 121 jo art. 49 first
paragraph Dutch 2007 Plant Protection Products and Biocides Act).
8 Classification and labelling
Proposed for classification and labelling for the formulation
Based on Reg. (EC) 1272/2008:

The identity of al substances in the mixture that contribute to the classification of the mixture *: alcohol ethoxylate Pictogram: Very toxic to aquatic life with long lasting effects Do not get in eyes, on skin, or on clothing. Wear protective gloves/protective clothing/eye protection/face protection P305+P351 IF IN EYES: Rinse cautiously with water for several +P338 + minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately cal a POISON Center or doctor/physician. Dispose of contents/container to hazardous or special waste col ection point information: Child-resistant fastening obligatory? * according to Reg. (EC) 1272/2008, Title III, article 18, 3 (b)
Remarks:
• P273 is assigned based on the H400 and H410 statements.
• According to the Guidance on label ing and packaging P280 is highly recommended for H318
• As the product contains a pyrethroid, and pyrethroids can produce very slight and reversible paresthesia (itching or tingling sensation), which is probably the result of local irritation of the peripheral nerves, P262 is assigned. 9 References

Emission Scenario Document for Wood Preservatives. OECD Series on Emission Scenario Documents. Organisation for Economic Co-operation and Development, Paris Regulation (EC) No 1005/2009 of the European Parliament and the Council of 16 September 2009 on substances that deplete the ozone layer.

Source: http://www.ctb.agro.nl/ctb_files/14016a_01.pdf

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C H A P T E R e 2 6 Amodiaquine Amodiaquine has been widely used in the treatment of malaria for >40 years. Like chloroquine (the other major 4-aminoquinoline), amodiaquine is now of limited use because of the spread of resis-tance. Amodiaquine interferes with hemozoin formation through complexation with heme. Although rapidly absorbed, amodiaquine behaves as a prodrug after oral

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