Icaridin Product-type 19 (Repellents and attractants) DOCUMENT I. Directive 98/8/EC concerning the placing biocidal products on the market.

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1 Directive 98/8/EC concerning the placing biocidal products on the market Inclusion of active substances in Annex I or IA to Directive 98/8/EC Draft CAR DOCUMENT I Icaridin Product-type 19 (Repellents and attractants) date SCB - RMS: Denmark Side 1 af 51

2 Icaridin (PT 19) Doc I Finalised in the Standing Committee on Biocidal Products at its meeting on date SCB in view of its inclusion in Annex I to Directive 98/8/EC CONTENTS 1. STATEMENT OF SUBJECT MATTER AND PURPOSE Procedure followed Purpose of the assessment report Overall conclusion in the context of Directive 98/8/EC OVERALL SUMMARY AND CONCLUSIONS Presentation of the Active Substance Identity, Physico-Chemical Properties & Methods of Analysis Intended Uses and Efficacy Classification and Labelling Summary of the Risk Assessment Human Health Risk Assessment Human health hazard identification and effects assessment...9 Reference value setting Human exposure assessment Risk characterisation for human health Environmental Risk Assessment Fate and distribution in the environment Effects assessment PBT assessment Exposure assessment Risk characterisation List of endpoints DECISION Background to the Decision Decision regarding Inclusion in Annex I...24 Page 2 of 51

3 3.3. Elements to be taken into account by Member States when authorising products Requirement for further information Updating this Assessment Report...24 APPENDIX I: LIST OF ENDPOINTS...26 Chapter 1: Identity, Physical and Chemical Properties, Classification and Labelling...26 Chapter 2: Methods of Analysis...29 Chapter 3: Impact on Human Health...30 Chapter 4: Fate and Behaviour in the Environment...33 Chapter 5: Effects on Non-target Species...35 Chapter 6: Other End Points...36 APPENDIX II: LIST OF INTENDED USES...37 APPENDIX III: LIST OF STUDIES...38 Page 3 of 51

4 1. STATEMENT OF SUBJECT MATTER AND PURPOSE 1.1. Procedure followed This assessment report has been established as a result of the evaluation of Icaridin as producttype 19 (Repellents and attractants), carried out in the context of the work programme for the review of existing active substances provided for in Article 16(2) of Directive 98/8/EC concerning the placing of biocidal products on the market 1, with a view to the possible inclusion of this substance into Annex I or IA to the Directive. Icaridin (CAS no ) was notified as an existing active substance, by Saltigo, hereafter referred to as the applicant, in product-type 19. Commission Regulation (EC) No 1451/2007 of 4 November lays down the detailed rules for the evaluation of dossiers and for the decision-making process in order to include or not an existing active substance into Annex I or IA to the Directive. In accordance with the provisions of Article 7(1) of that Regulation, Denmark was designated as Rapporteur Member State to carry out the assessment on the basis of the dossier submitted by the applicant. The deadline for submission of a complete dossier for Icaridin as an active substance in Product Type 19 was 30 April 2006, in accordance with Annex V of Regulation (EC) No 1451/2007. On 20 April 2006, the Danish competent authorities received a dossier from the applicant. The Rapporteur Member State accepted the dossier as complete for the purpose of the evaluation on 4 July On 16 April 2007 the evaluation was suspended due to a request from the RMS for further studies on skin sensitization and developmental toxicity. The data were submitted by the Applicant in December On 14 January 2011, the Rapporteur Member State submitted, in accordance with the provisions of Article 14(4) and (6) of Regulation (EC) No 1451/2007, to the Commission and the applicant a copy of the evaluation report, hereafter referred to as the competent authority report. The Commission made the report available to all Member States by electronic means on [date]. The competent authority report included a recommendation for the inclusion of Icaridin in Annex I to the Directive for product-type 19. In accordance with Article 16 of Regulation (EC) No 1451/2007, the Commission made the competent authority report publicly available by electronic means on [date]. This report did not 1 Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing biocidal products on the market. OJ L 123, , p.1 2 Commission Regulation (EC) No 1451/2007 of 4 December 2007 on the second phase of the 10-year work programme referred to in Article 16(2) of Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market. OJ L 325, , p. 3 Page 4 of 51

5 include such information that was to be treated as confidential in accordance with Article 19 of Directive 98/8/EC. In order to review the competent authority report and the comments received on it, consultations of technical experts from all Member States (peer review) were organised by the Commission. Revisions agreed upon were presented at technical and competent authority meetings and the competent authority report was amended accordingly. On the basis of the final competent authority report, the Commission proposed the inclusion of Icaridin in Annex I to Directive 98/8/EC and consulted the Standing Committee on Biocidal Product on date SCB. In accordance with Article 15(4) of Regulation (EC) No 1451/2007, the present assessment report contains the conclusions of the Standing Committee on Biocidal Products, as finalised during its meeting held on date SCB Purpose of the assessment report This assessment report has been developed and finalised in support of the decision to include Icaridin in Annex I to Directive 98/8/EC for product-type 19. The aim of the assessment report is to facilitate the authorisation in Member States of individual biocidal products in producttype 19 that contain Icaridin. In their evaluation, Member States shall apply the provisions of Directive 98/8/EC, in particular the provisions of Article 5 as well as the common principles laid down in Annex VI. For the implementation of the common principles of Annex VI, the content and conclusions of this assessment report, which is available at the Commission website 3, shall be taken into account. However, where conclusions of this assessment report are based on data protected under the provisions of Directive 98/8/EC, such conclusions may not be used to the benefit of another applicant, unless access to these data has been granted Overall conclusion in the context of Directive 98/8/EC The overall conclusion from the evaluation is that it may be expected that there are products containing Icaridin for the product type 19, which will fulfil the requirements laid down in Article 5 of Directive 98/8/EC. This conclusion is however subject to: i. compliance with the particular requirements in the following sections of this assessment report, ii. the implementation of the provisions of Article 5(1) of Directive 98/8/EC, and iii. the common principles laid down in Annex VI to Directive 98/8/EC. 3 Page 5 of 51

6 Furthermore, these conclusions were reached within the framework of the uses that were proposed and supported by the applicant (see Appendix II). Extension of the use pattern beyond those described will require an evaluation at product authorisation level in order to establish whether the proposed extensions of use will satisfy the requirements of Article 5(1) and of the common principles laid down in Annex VI to Directive 98/8/EC. Page 6 of 51

7 2. OVERALL SUMMARY AND CONCLUSIONS 2.1. Presentation of the Active Substance Identity, Physico-Chemical Properties & Methods of Analysis CAS-No EINECS-No Other No. (CIPAC, ELINCS) CIPAC No. 740 IUPAC Name C.A. Name Common name, Synonyms (RS)- sec-butyl 2-(2-hydroxyethyl)piperidine-1-carboxylate 1-Piperidinecarboxylic acid, 2-(2-hydroxyethyl)-1-methylpropylester Icaridin Bayrepel KBR 3023 Picaridin Molecular formula C 12 H 23 NO 3 Structural formula HO H 3 C O CH 3 O N SMILES: C1C (N (CCC1) C (OC (C) CC) =O) CCO Molecular weight (g/mol) Purity 97% Impurities Confidential information. See confidential annex. None of the manufacturing impurities are considered to be of potential concern. Icaridin is a colourless and odourless liquid. No freezing, melting, crystallisation or glass transition was observed in a temperature range between -170 C and 20 C. The boiling point of Icaridin is 296 C at 1013 hpa, its density 1.07 g/ml at 20 C and its vapour pressure Pa at 20 C. The water solubility of Icaridin is 8.2 g/l in one study and 10.6 g/l in another study, both at 20 C. It is not influenced by the ph in the range ph 4 to ph 9 but by temperature in the range 10 C to 30 C. The log Pow of Icaridin is 2.23 at 20 C. This parameter is not influenced by the ph in the range ph 4 to ph 9 but shows slight temperature dependence between 20 C and 50 C. The surface tension is 49 mn/m at 20 C and Icaridin is regarded as surface active. Its viscosity is Pa s at 23 C and a shear rate from 0 to 100 s -1. Page 7 of 51

8 The flash point is 142 C at 1007 hpa and 151 C at 1027 hpa. Icaridin does not have oxidising, pyrophoric or explosive properties. The methods of analysis for the active substance as manufactured, and for the determination of impurities, have been validated. The methods for analysis in soil have been validated and shown to be sufficiently sensitive with respect to the levels of concern. The method in water is not sufficiently validated. The method for air is not acceptable as carbon tetrachloride is used as solvent and as the method is not sufficiently validated. However, air is not a compartment of concern for Icaridin due to the short half-life of the compound in the atmosphere (DT50 = 6.87 hours) and the low vapour pressure ( Pa at 20 C). The RMS therefore suggests not requiring an analytical method for determining Icaridin residues in air. Further data on analytical methods for determining Icaridin and Icaridin-acid residues in surface water and groundwater is thus a data requirement and the RMS suggests requiring these data at the product authorisation stage. Furthermore an analytical method for determining Icaridin-acid residues in soil is lacking. For Icaridin no analytical method is required for the determination of residues in animal and human body fluids and tissues or residues in food or feedstuff Intended Uses and Efficacy Icaridin is used as a skin applied insect repellent to protect humans against biting arthropods (mosquitoes, biting midges, flies and ticks). The assessment of the biocidal activity of the active substance demonstrates that Icaridin has a sufficient level of efficacy against the target organism(s) and the evaluation of the data provided in support of the efficacy of the accompanying product, establishes that the product is expected to be efficacious. For the annex I inclusion of Icaridin the evaluation has been performed with a representative biocidal product (containing 20% Icaridin) against mosquitoes. Products with different compositions or against other target organisms will need to be assessed at Member State level. In addition, in order to facilitate the work of Member States in granting or reviewing authorisations, and to apply adequately the provisions of Article 5(1) of Directive 98/8/EC and the common principles laid down in Annex VI of that Directive, the intended uses of the substance, as identified during the evaluation process, are listed in Appendix II Classification and Labelling Classification and labelling of the active substance No current classification and labelling of Icaridin are given in accordance with Annex I of Council Directive 67/548/EEC. There is also no classification of Icaridin according to the CLP Regulation 1272/2008. Page 8 of 51

9 No proposed classification / labelling for Icaridin results from its physico-chemical, toxicological, environmental and ecotoxicological properties. Classification of the product Regarding its physico-chemical properties, the representative biocidal product (20% Icaridin) would be classified / labelled according to Directive 1999/45/EC and Regulation 1272/2008 as given in the tables below. No classification results from the toxicological and ecotoxicological properties. Proposed classification of the representative biocidal product (20% Icaridin) according to Directive 1999/45/EC Hazard symbol: Indication of danger: Not required on this product. Not required on this product. Risk phrases: R10: Flammable. Safety phrases: S2: Keep out of the reach of children. Proposed classification of the representative biocidal product (20% Icaridin) according to Regulation 1272/2008 Hazard symbol: GHS02 Signal Word: Hazard statements Precautionary statements Warning H226: Flammable liquid and vapour P210: Keep away from open flames. No smoking Summary of the Risk Assessment Human Health Risk Assessment Human health hazard identification and effects assessment The toxicity data for the active substance Icaridin has been generated with focus on the dermal route of exposure. Thus, repeated-dose toxicity, carcinogenicity, and reproductive toxicity Page 9 of 51

10 testing has been conducted by the dermal route. A number of the dermal studies show no effects at the highest dose level. Studies performed with other animals than rats are not accompanied by dermal absorption data. The absorption, metabolism and excretion of Icaridin were investigated in rats and in human volunteers following dermal exposure. No data on ADME though oral route were available. Both humans and rats predominantly excreted Icaridin via the urine following dermal exposure. More than 93% of the dose absorbed by human volunteers was recovered from urine collected during the first 24 h after dosing. In rats, the majority of absorbed radioactivity was excreted within the first two days after treatment. The metabolic pathway was similar in both species. Phase-I reactions included hydroxylation of the piperidine ring and the isobutyl moiety as well as oxidation of the terminal carbon in the hydroxy-ethyl side chain was the major metabolism pathway in rats. In humans, Phase-II metabolism was the major pathway. The vast majority of the metabolites appear both in rat and man, however in different concentrations. No metabolites are regarded to be of toxicological concern. In the dermal ADME-study in rats dermal absorption was investigated after single and repeated exposure (15 days) to a dose of 20 mg/kg, as well as single exposure to a high dose of 200 mg/kg bw. The results showed that dermal absorption was depending on the dose level but independent of sex. The amount absorbed through the skin ranged from 40-63% of the applied dose: The mean dermal absorption (skin and urine and organs) was 61% after a single dose of 20 mg/kg and 61% after repeated exposure to 20 mg/kg bw/day. These results indicate that single dose administration compared to a repeated dose administration (pre-treated dose group) has no impact on the absorption fraction. After a single dose of 200 mg/kg the mean dermal absorption was 47%. Thus, the absorbed fraction decreased from low dose groups to high dose groups. In an in vivo dermal penetration study in rats, the average dermal absorption values (both sexes) after 8 hours exposure for applied Icaridin doses of 8, 40 and 200 mg/kg bw/day were 23%, 19% and 17%, respectively. The mean dermal absorption value of 47% from exposure over 24h to 200 mg/kg bw dose is used for the calculation of the internal dose in the subchronic dermal study in the rat. In human volunteers, the dermal penetration by Icaridin was less than 4%. Icaridin is of low acute oral, dermal and inhalatory toxicity and no classification is warranted. Icaridin is not irritating to the skin and slightly irritating to the eye without fulfilling the criteria for a classification for this end-point. Icaridin was not sensitising in the Maximisation test on guinea pigs. Repeated administration of Icaridin to rats via the dermal or oral route revealed effects on liver and kidney manifested as increased organ weights and the microscopic correlates, hepatocellular hypertrophy and degenerative nephropathy. The liver effects were not associated with functional changes and all effects were fully reversible within a 4-week post-exposure Page 10 of 51

11 period. Therefore, these effects were therefore appraised as being non-adverse. The kidney effects are only observed in male rats and therefore suggestive of an α2-microglobulin effect. However, as this mechanism was not shown, the effects on the kidney are taken into considered when setting NOAEL in repeated dose toxicity studies. Repeated dermal exposure of rats to Icaridin caused scab formation, acanthosis and hyperkeratosis at all doses in a dose-dependent relationship. Since the use of the substance is as a dermally applied repellent, contact with the skin over a prolonged are expected the effect may therefore be relevant. However, the dosing regime in all repeated-dose dermal studies with Icaridin in the rat featured continuous exposure to the test substance as no wiping or washing off prior to the next dosing was used. This exposure pattern thus differs from the intermittent pattern of consumer use of repellent products. In addition, this effect is not observed in the 1 year dog study or the chronic mouse study. It is therefore doubtful that the findings on rat skin are relevant for the human user. Therefore, the effect is regarded not to be relevant to the human risk assessment. It could also be speculated whether acanthosis in the rat could have an impact on the dermal absorption in the dermal studies by decreasing the dermal absorption, but this was not apparent in a comparison of single-dose versus repeated-dose dermal absorption (both ~60%) in the ADME study. As the local effects were deemed of lesser relevance for humans, no risk characterisation for local effects was performed. In the dermal one-year studies in rats and dogs, the high-dose level was set to 200 mg/kg/day. At nominally 200 mg/kg in male rats, an increased incidence of cystic liver degeneration with a clear dose-response relationship was observed at 200 mg/kg bw/day, with no effect on liver weight. The toxicological significance of the finding is unclear. No other systemic effects were seen in this study. Icaridin was non-mutagenic in bacteria and mammalian cells. Clastogenic effects in a mammalian cell line were detected only at concentrations that produced clear cytotoxicity. Icaridin did not induce DNA-repair activity in primary rat hepatocytes. Icaridin was negative in an in-vivo micronucleus test in mice. Overall, the weight of evidence suggests that Icaridin is of no genotoxic concern. The combined chronic/carcinogenicity studies in rats and mice were also conducted using dermal exposure to Icaridin. The highest nominal dose level was 200 mg/kg bw/day in both species. No adverse systemic effects were reported. The incidence of neoplastic lesions in rats was not affected by Icaridin at any tested dose. In mice no skin tumours were observed under the condition of the cancer study. However, as no signs of toxicity were reported in the study at any dose level, no conclusion on long term or carcinogenic effects could be drawn. Teratogenicity studies with dermal exposure to Icaridin were conducted in rats and rabbits. In rats, the highest nominal dose tested was 400 mg/kg bw/day. As expected from the 90-day dermal toxicity study in rats, the dams in the high-dose group responded with increased liver weights. Embryotoxic effects in rats at maternally toxicity levels were noted as delayed ossification at 400 mg/kg/day in the dermal study. The study on rabbits included a high-dose level of 200 mg/kg/day. Neither does nor foetuses were affected by Icaridin at any dose level. Dermal absorption of Icaridin in rabbits is low (5.5%) and no data is available on serum levels Page 11 of 51

12 of Icaridin in the doe or the foetus. Therefore the study is not valid for risk assessment purposes of the endpoint of teratogenicity. In the oral dose range finding teratogenicity study in the rat (single dose of 500 mg/kg bw/day) for embryotoxic effects foetal ossifications were noted. The embryotoxic effect correlated with maternal toxicity. An oral developmental toxicity study in rabbits was conducted at the request of the RMS. The new oral rabbit study revealed maternal and foetal toxicity at 300 and 1000 mg/kg bw/day but no specific teratogenic effects on the foetuses. Maternal toxicity was seen as reduced feed intake, bw loss, clinical signs and abortion. Embryotoxicity were seen as reduced weights and retarded ossification at several sites. The dermal two-generation reproduction study on rats found no treatment-related effects up to and including the highest nominal dose level of 200 mg/kg/day. However, identification of long-term or reproductive effects is generally not technically feasible on the basis of dermal studies alone, which indeed has been shown here. A study focusing on potential neurotoxic effects in rats during subchronic exposure to Icaridin found no effects at doses up to and including 200 mg/kg bw/day. Acute neurotoxicity testing found no substance-related neurotoxicological effects at the highest dose tested (2000 mg/kg bw). As discussed above the inherent systemic toxicological properties of Icaridin are not fully covered by this dossier. However due to the specific application of Icaridin as a repellent on the skin the dermal studies are relevant for the assessment of the dermal toxicity of Icaridin in doses comparable to doses used on humans. The RMS considers the dossier acceptable for the risk assessment of Icaridin because the foreseeable route of systemic exposure for this insect repellent is through the dermal route. However this implies that the dossier is only sufficient to support Icaridin into annex I as an active substance in dermally applied insect repellents, and restriction to this use should be retained as the dossier does not cover all potential inherent systemic effects of the substance. Table 2.2-1: Summary of LOAEL and NOAEL settings Study Species Nominal doses [mg(kg bw/day] End point LOAEL [mg/kg bw/day] NOAEL [mg/kg bw/day] Reference 5-week oral Rat 0,90/121,152/ 189,308/360 or1034/1141 Reduced BWG and nephropathy ( ) confidential 14-week oral Rat 0,100,150,300 or 1000 Reduced BW and BWG, increased kidney weights ( + ) confidential 13-week dermal Rat 0,80,200,500 or 1000 Renal tubular degeneration and chronic inflammation ( ) confidential Page 12 of 51

13 Study One-year dermal Chronic/carcino genicity, dermal Teratogenicity, dermal Teratogenicity, oral Twogeneration, dermal Neurotoxicity, subchronic, dermal Species Rat Dog Rat Mouse Rat Rabbit Rat Rat Nominal doses [mg(kg bw/day] 0,50,100 or 200 0,50,100 or 200 0,50,100 or 200 0,50,100 or 200 0,50,200 and 400 0,100,300 or ,50,100 or 200 End point Liver effects (cystic degeneration) ( ) LOAEL [mg/kg bw/day] NOAEL [mg/kg bw/day] No effects > No systemic effects/ No neoplastic effects No systemic effects/ No skin tumours observed > > Reference confidential confidential confidential confidential Maternal liver weight confidential Delayed foetal ossification Maternal Bw and feed intake, clinical signs and abortions Foetal Bw, delayed ossification confidential Parental: No effects > confidential Offspring: No effects > , 50,100 or 200 No effects > confidential Reference value setting The TNsG on Annex I inclusion recommends that the risk characterisation be performed using both an AOEL (AEL) approach and a Margin of Exposure (MoE) approach. The MoE is the critical internal NOAEL divided by the calculated exposure and should be higher than the relevant assessment factor for an acceptable risk. For Icaridin, the overall quality of the available database does not give reason for reducing the default overall assessment factor of 100, based on a factor 10 for interspecies extrapolation and another factor 10 for intraspecies variability, is used for the AEL setting as well as for calculation of the MoE in section below. AELs for short-term and medium-term exposure are calculated by applying an assessment factor to the internal NOAEL on the critical effect (degenerative nephropathy and increased kidney weights) divided by the relevant assessment factor. Due to the seasonal, intermittent use over 4-5 months of products containing Icaridin, setting a chronic AEL is not considered to be relevant. Page 13 of 51

14 The 5-week oral NOAEL of 308 mg /kg bw/day is used for the derivation of the short-term AEL. In lack of information as to the oral absorption, 100% is assumed, and no correction for oral absorption is included in the calculation of AEL short term : AEL short term = 3.1 mg/kg bw/day. The most relevant NOAEL that is for human exposure to Icaridin in repellent products is the dermal 13-week NOAEL of 500 mg/kg bw/day. This value needs to be corrected for the permeability of rat in order to calculate the systemically available dose. As a result, the medium-term AEL is: AEL medium, dermal = 2.4 mg/kg bw/day. ADI is a reference value, which can be used e.g. if there is an assumption of dietary or possible drinking water contamination. The chronic dermal NOAEL of 100 mg/kg bw/day based on the one year study in rats is used, resulting in the following value: ADI = 1 mg/kg bw/day A drinking water limit (DWL) is calculated based on the assumption that a maximum 10% of the ADI is consumed by exposure via drinking water, and on the WHO adult daily drinking water consumption estimate of 2 L. Thus, DWL = 3.0 mg/l Human exposure assessment Repellents are applied on the uncovered skin: on the head, hands, arms, legs and feet. Exposure takes place dermally and orally. The primary exposure path is the dermal path, as insect repellents are usually applied by direct spraying onto skin and then spread by hand. Hand-tomouth contact may occur, leading to the ingestion of some of the repellent. Exposure due to hand-mouth contact will mainly be important for children. It is evaluated that exposure via inhalation normally is low or absent due to the use outdoors, and because use indoors mainly takes place in the summer in situations where there is generally a high ventilation rate. Indirect exposure may occur through drinking water contamination. Calculation of exposure in a Tier I was is based on TNsG default assumptions on use pattern for insect repellents, e.g. area of body treated and application rates. In a Tier II, refinement of the exposure calculation was introduced in accordance with the proposed label requirements for the representative product that exclude the use of the product for children under the age of 2, so that children of 10.5 mths are excluded from the calculations. Also, the addition of a bittering agent to the product and product specific data on application rate and frequency are included. In Tier III, the treated surface of the body is corrected in accordance with an EPA survey. Calculation of drinking water levels showed negligible levels of Icaridin. A summary of the results of the calculation of the exposure to Icaridin through the use of the representative biocidal product (20% Icaridin) is shown below in Table Table 2.2-2: Assumptions and results of the tiered exposure assessment Page 14 of 51

15 Tier I II III Population Body weight [kg] Amount b.p. per application [g] Number of applications [1/day] Oral uptake [% of dermal dose] Adult Child, 3 yrs Infant 10,5 mths Adult Child, 3 yrs Adult Child, 3 yrs Total systemic dose [mg/kg bw/day] Risk characterisation for human health AEL approach The internal dose following dermal primary exposure to the Icaridin-containing repellent product, Autan Pump Spray 20%, and the comparison with the AEL medium term, is summarised in Table Table 2.2-3: AEL approach: Risk assessment for exposure to the representative product (20% Icaridin) Parameter Tier Total systemic exposure [mg/kg bw/day] AEL medium term [mg/kg bw/day] Adults I II III Child, 3 years Infant, 10.5 mths Adults Child, 3 years Adults Child, 3 years AEL consumption 130% 395% 342% 63% 100% 46% 50% Under the Tier I evaluation of the exposure, based on default assumptions from the TNsG, the AEL is exceeded during the use phase of the representative product (20% Icaridin) due to the dermal and oral exposure to Icaridin in adults, in children of 3 years as well as infants of 10.5 months as the exposure was 130, 395 and 342% of the AEL. When the exposure assessment is refined in Tier II, including product specific information on efficacy and on the basis of the proposed RMMs (bittering agent and exclusion of use of the product for children under 2 years), the medium-term AEL is not exceeded for adults (63%), while the exposure of children of 3 years consumed 100% of the medium-term AEL. In Tier III, refinement based on considerations on the treated area of the body in adults and children, with data from a US-EPA survey, are included. This refinement results in comfortable Page 15 of 51

16 margins between exposure and AEL with figures of 46 and 50% for adults and children of 3 years. MoE approach The MoE calculation are summarised in Table The NOAEL corrected for dermal absorption in compared to the internal exposure level. For Icaridin, the default MoE of 100 is used. The risk is thus considered acceptable if the MoE is greater than 100. Table 2.2-4: MoE approach: Risk assessment for exposure to the representative biocidal product (20% Icaridin) Parameter Tier I II III User Adult Child 3 years Child 10.5 months Adult Child 3 years Adult Child 3 years NOAEL internal [mg/kg bw/day] Total systemic exposure [mg/kg bw/day] MoE The calculated MoE s are exceeded at Tier I level for adults and children of <3 years and children of 10.5 months. At Tier II level, the MoE is sufficient for adults, but slightly too low for children of 3 years. There is safe use at Tier III for adults and children of 3 years. Conclusion of Risk Characterisation The risk characterisation for human health for Icaridin was based on the representative product (20% Icaridin), and comparing the effects on human health with exposure. In Tier I, the risk characterisation is based on the assessment of the realistic worst case as presented by the applicant and referring to the TNsG on human exposure. This evaluation demonstrated that there is an unacceptable risk from the use of a representative product (20% Icaridin) as an insect repellent. Refinement of the exposure assessment in a Tier II and Tier III approach with product specific data and introduction of risk mitigation measures shows that safe use for human health of the representative Icaridin-based product. Thus, there is no concern for human health from the use of Icaridin as an insect repellent, provided relevant risk mitigation measures and use pattern are implemented e.g. that a bittering agent should be included in the recipe of the Icaridin based product, that the Icaridin based product is not used for children under the age of 3, Page 16 of 51

17 that the daily number of applications should be considered carefully in relation to the concentration of the product. that the Icaridin product is applied to bare skin only, and that summer clothing (shorts and short sleeved shirt) should be worn when using an Icaridin based insect repellent Environmental Risk Assessment Fate and distribution in the environment Icaridin is hydrolytically stable determined under environmental ph and temperature conditions. Due to its lack of UV absorbance in the sunlight region Icaridin is not degradable by direct photodegradation in water. The tropospheric half-life of Icaridin was estimated using the AOPWIN program. The program is based on a quantitative structure analysis developed by Atkinson. The Atkinson calculation method sums up the reactivity towards OH radicals of all structural elements. Using a 24-hours day and a mean daily OH concentration in air of 0.5 x 10 6 OH radicals per cm³, a half life in air of 6.87 hours was assessed. The calculation indicates a rapid degradation of Icaridin when potentially entering the atmosphere. Hence, air will not be an environmental compartment of concern for the compound used in repellents. Based on the Modified OECD Screening Test, Icaridin is concluded to be not ready biodegradable. Based on the results of the Zahn-Wellens/EMPA-Test, the test substance was also not inherently biodegradable. Based on the estimated K oc value of L/kg Icaridin can be assumed to have a high potential for mobility in soils. The average BCF-values for Zebrafish (whole fish, wet weight) were shown to be 1.8 and 0.9 for Icaridin concentrations of 0.1 and 1.6 mg/l (98.3 % Icaridin). Referring to the lipid content of wet weight, BCF values of 19 and 10 were calculated for test substance concentrations of 0.1 and 1.6 mg/l. During the examined depuration period (44 h) the measured Icaridin concentration in fish tissue decreased below the detection limit (100 µg/kg wet weight). The BCF related to the lipid content is above 1, but taking into consideration the fast depuration, a significant food chain concern does not exist. Monitoring data (see Doc IIB, 3.3.5) show that Icaridin probably undergoes transformation to the more stable metabolite Icaridin-acid in the STP. Page 17 of 51

18 Effects assessment Acute toxicity of Icaridin to aquatic organisms is very low. The most sensitive species in chronic tests on Icaridin is Danio rerios (zebra fish). The NOEC in a 21 day flow-through system was mg/l. Data on chronic daphnia toxicity and algae toxicity are available, too. Therefore, an assessment factor of 10 was applied on the long-term fish toxicity NOEC resulting in a PNEC water of µg/l for Icaridin. For Icaridin as a non-biodegradable substance, being characterised by a log K oc of L/kg, 98.9 % of the STP inflowing residues will still be present in the water phase of the STP effluent and 1.05 % in the sludge. For the sediment no toxicity data are available. The PNEC value has been calculated based on the equilibrium partitioning method and PNEC water. PNEC sed = 0.84 mg Icaridin/kg wwt. The calculation of the PNECsoil is based on the test with non-target plants (EC 50 value = mg Icaridin/kg dry weight soil. Data on acute toxicity to earthworms was also available and thus, an assessment factor of 1000 is applied to the LC 50 value of the plant test. PNEC soil = mg Icaridin/kg dry weight soil = mg Icaridin /kg wet weight soil. For the metabolite Icaridin-acid QSAR modelling with Epiwin version 3.11 estimates the aquatic toxicity of Icaridin-acid to be 2-5 times more toxic than Icaridin itself, when compared to QSAR modelling of Icaridin. Thus, the toxicity of the metabolite Icaridin-acid is estimated to be in the same range as Icaridin. The risk assessment is therefore performed with Icaridin and is expected to cover both Icaridin and Icaridin-acid PBT assessment Icaridin is not ready or inherently biodegradable and is thus regarded as being potentially persistent. For Icaridin the calculated bioconcentration factor in fish is 1.8 related to wet weight. Therefore, the B criterion is not fulfilled. The NOEC value for zebra fish (Danio rerio), the most sensitive aquatic species, is mg/l after 21 days. Therefore the T criterion is not fulfilled. There are no indications for CMR or endocrine disrupting properties. Thus Icaridin is not a PBT substance Exposure assessment Page 18 of 51

19 Predicted environmental concentrations were calculated using two approaches: the consumption-based approach and the tonnage-based approach. The tonnage-based approach is based on confidential data and can be found in the confidential annexes. For both approaches the release to wastewater was set as 81% due to volatilisation from the skin after application. Calculation of PEC in the aquatic environment (STP, surface water and sediment) The calculation of the PEC STP was conducted on the bases of post-consumer release prediction, consumption data and default values related to the water treated in a WWTP. The result was a Predicted Environmental Concentration of mg/l for a standardised European STP. However, monitoring measurements of Icaridin concentrations in STP influents reveal maximum concentrations (6.4 µg/l) significantly lower than those calculated, indicating, that the PEC STP calculated must be understood as a worst-case result. The monitoring data has been used as supporting data as they were not supported with sufficient information to base the exposure assessment on measured data. The calculated PEC surface water value ( mg/l) is a consequence of discharge from a STP to a water body. Monitoring data indicate that Icaridin undergoes a primary degradation/transformation in WWTPs, yielding the more stable metabolite Icaridin acid. The available data for Icaridin (non-biodegradable; log K oc = L/kg) indicate that residues will mainly be present in the water phase (98.9%). The PEC sediment is calculated according to the TGD. PEClocal sed = mg* kg -1. Calculation of PEC in soil Soils are indirectly exposed to Icaridin residues by an application of sewage sludge. A tier 1 PEC calculation for soils has been done using the PT 1 emission scenario in EUSES. The tier 1 local PEC soil averaged over 30 days was calculated to be mg * kg wwt -1. For tier 2 the seasonal use-pattern of insect repellents was taken into account assuming 5 months of use out of 12 months. The tier 2 local PEC soil averaged over 30 days was calculated to be mg * kg wwt -1. Calculation of PEC in air Icaridin has a vapour pressure of 3.4 x 10-2 Pa at 20 C and is therefore regarded as low volatile. However, the repellent effect is associated with an enduring slight volatilisation of compound from the skin surface. According to a further study 10.3% to 26.8% of the applied radioactivity (mean 18.6%) could potentially volatilise during the 8 hours period following the application. However, volatile Icaridin amounts cannot be considered to pose a risk for the environmental compartments. With respect to the deposition of residues from the atmosphere to soils, this route can be neglected due to the short tropospheric half-life of Icaridin estimated to account for 6.87 hours. The calculation of PEClocal values for the atmosphere is therefore of no relevance. Calculation of PEC in groundwater Page 19 of 51

20 In a first Tier, the PEC for groundwater has been calculated using EUSES (PT 1 emission scenario) as the concentration in the porewater below agricultural soil. Since Icaridin is neither ready nor inherently biodegradable and since no degradation studies in soil have been performed, it is assumed that Icaridin is not degraded in soil. The tier 1 local PEC porewater is 0.05 mg/l. For tier 2 the seasonal use-pattern of insect repellents was taken into account assuming 5 months of use out of 12 months. The tier 2 PEC porewater is mg/l. In Tier 3 a FOCUS PEARL modelling has been conducted, assuming either Icaridin or Icaridin acid to be present in dry sewage sludge and to be applied to soil according to FOCUS recommendations. Figures for the Icaridin and Icaridin-acid degradation in soil were obtained by QSAR (EPIWIN) estimations. The FOCUS modelling has only been carried out for the tonnage-based approach and the exact figures can be seen in the confidential annex to doc. IIB. The calculations with FOCUS PEARL resulted in 80 th percentile PEC gw below 0.1 µg/l for all 9 scenarios. Aquatic compartment: Risk characterisation Compartment PEC (µg/l) PNEC (µg/l) PEC/PNEC Sewage treatment plant Surface water Sediment µg/kg 840 µg/kg 0.2 The derived risk quotients are < 1, even using the worst-case assumptions for the calculation. Thus, it is considered that there is no relevant risk for the aquatic environment (including STP and sediment) caused by Icaridin dermally applied in repellent products. Bioconcentration: The average BCF-values for zebra fish (whole fish, wet weight) were shown to be maximum 1.8 for KBR Referring to the lipid content of wet weight, BCF values of maximum 19were calculated. During the examined depuration period (44 h) the measured Icaridin concentration in fish tissue decreased below the detection limit (100 µg/kg wet weight). The BCF related to the lipid content is above 1, but taking into consideration the fast depuration, a significant food chain concern does not exist. Atmosphere: Not relevant for Icaridin due to the short half-life of the compound in the atmosphere (DT50 = 6.87 hours). Page 20 of 51

21 Soil: Compartment PEC (mg/kg) PNEC (mg/kg) PEC/PNEC Tier 1 Soil 30 days Tier 2 Soil 30 days The calculation revealed a tier 2 PEC/PNEC relation for the soil compartment below the trigger value of 1 indicating no unacceptable risk for soil organisms. Groundwater: As an indication for potential groundwater levels, the concentration in porewater of agricultural soil is taken. In Tier 2 the seasonal use pattern of Icaridin products has been taken into account. Compartment PEC GW [µg a.s./l] PNEC GW [µg a.s./l] PEC PNEC Tier 1 Ground water (porewater of agricultural soil) Tier 2 Ground water (porewater of agricultural soil) In a third tier a FOCUS PEARL modelling has been conducted, assuming either Icaridin or Icaridin acid to be present in dry sewage sludge and to be applied to soil according to FOCUS recommendations. As this modelling has only been carried out for the tonnage-based approach, the calculations can be found in the confidential annex of doc. IIB. In summary, the tier 1 and 2 EUSES calculation gave concentrations in porewater/groundwater exceeding the legal drinking water limit for single pesticide substances of 0.1 µg/l. However, the Tier 3 calculations for Icaridin and Icaridin acid with FOCUS PEARL resulted in 80 th percentile PEC gw below 0.1 µg/l for all 9 scenarios. Conclusion Consumption-based approach: The risk characterisation for the environment was based on the representative biocidal product (20% Icaridin), and comparing the effects on the environment with exposure. In Tier I an Page 21 of 51

22 unacceptable risk for the soil and groundwater was found from the use of a representative biocidal product (20% Icaridin) as an insect repellent. Refinement of the exposure assessment in a Tier II approach taking into account that insect repellents have a seasonal use pattern demonstrated safe use for the terrestrial environment. In a tier III FOCUS PEARL groundwater modelling was employed, which demonstrated PEC gw below 0.1 µg/l for all 9 scenarios for both Icaridin and Icaridin acid. Tonnage-based approach: The tier I PEC/PNEC ratios are below 1 for all environmental compartments except groundwater, indicating that no risk is to be expected for the organisms inhabiting these compartments. The tier II groundwater calculations for Icaridin and Icaridin acid with FOCUS PEARL gave 80 th percentile PEC gw below 0.1 µg/l for all 9 locations. Thus, there is no concern for the environment from the use of Icaridin as an insect repellent applied once a day List of endpoints In order to facilitate the work of Member States in granting or reviewing authorisations, and to apply adequately the provisions of Article 5(1) of Directive 98/8/EC and the common principles laid down in Annex VI of that Directive, the most important endpoints, as identified during the evaluation process, are listed in Appendix I. 3. DECISION 3.1. Background to the Decision The overall conclusion from the evaluation of Icaridin for use as an insect repellent (PT19) for non-professional users is that the substance fulfils the safety requirements laid down in Article 10(1) of Directive 98/8/EC. It is expected that it will be possible for MS to issue authorisations for products containing Icaridin in accordance with the conditions laid down in article 5 (1) (bd) of Directive 98/8/EC. Icaridin is therefore proposed for inclusion on to Annex I of that Directive. The efficacy of Icaridin at repelling different species of biting arthropods has been demonstrated in tests on Icaridin containing products. Icaridin is of low toxicity to human health, the target organs being the liver, where reversible adaptive changes are seen and the kidney, where repeated exposure to levels of around 1000 mg/kg bw/day result in increased kidney weights and degenerative changes. Human exposure of Icaridin occurs primarily through dermal exposure of intermittent use. Oral exposure is relevant especially for children. A risk assessment was performed on a representative product. The risk assessment was refined including exposure reducing measures in form of use of a bittering agent, restriction of users to children over 3 years and reduction of the number of daily applications based on efficacy testing information on the product. The result of this risk assessment shows that there is safe use for human health of the Icaridin-based product. Page 22 of 51

23 The toxicity of Icaridin to the environment is low, but Icaridin is not ready or inherently degradable. Icaridin undergoes a primary degradation/transformation in WWTPs, yielding the more stable metabolite Icaridin acid. QSAR analysis of Icaridin-acid estimates a toxicity in the same range as Icaridin. The risk assessment has thus been carried out for Icaridin and revealed PEC/PNEC ratios of less than 1 for all compartments. Icaridin has a BCF > 1 related to lipid content, but since the depuration is rapid no risk for bioaccumulation is anticipated. QSAR analysis estimates the BCF for Icaridin-acid to be in the same range. Based on the above it can be concluded that Icaridin will not pose an unacceptable risk to any of the environmental compartments. The physico-chemical properties of the active substance and biocidal product are deemed acceptable for the appropriate use, storage and transportation of the active substance and biocidal product. The analytical method for detection of Icaridin in soil is the only acceptable method for environmental matrices. Methods for the analysis of Icaridin in water and Icaridin-acid in soil and water must be submitted at the product authorisation stage. Page 23 of 51

24 3.2. Decision regarding Inclusion in Annex I Icaridin shall be included in Annex I to Directive 98/8/EC as an active substance for use in product-type 19 (Repellents and attractants), subject to the following specific provisions: The active substance, Icaridin, as manufactured shall have a minimum purity of 97% w/w. Member States shall ensure that authorisations are subject to the following conditions: (1) Exposure of humans shall be minimized by the application of appropriate risk mitigation measures, including, where applicable, instruction for the method, amount and frequency of application of the product on human skin; (2) Icaridin based product must contain a deterrent for ingestion. (3) Labels for Icaridin based products shall indicate that the product is not intended for use on children under 3 years, unless it can be demonstrated at product authorisation hat the product will meet the requirements of Article 5 and Annex VI of this Directive without such a measure 3.3. Elements to be taken into account by Member States when authorising products As indicated above, risk reduction measures should be considered in view of reducing the exposure to Icaridin. Such measures could for example include avoiding use of the product under clothing, reducing the area of skin treated, restricting the number of daily application, or reducing the concentration in the product. Any potential for direct exposure to surface water as a consequence of swimming etc. has not been assessed at the European level. Special attention should be given to the recommendation of rate of exposure and duration of efficacy of the product, as this could differ between target species Requirement for further information It is considered that the evaluation has shown that sufficient data have been provided to verify the outcome and conclusions, and permit the proposal for the inclusion of Icaridin in Annex I to Directive 98/8/EC. However, further validation data to prove the acceptability of the proposed analytical methods for the water compartment is needed. Methods for the analysis of Icaridin in water and Icaridinacid in soil and water must be submitted at the product authorisation stage Updating this Assessment Report This assessment report may need to be updated periodically in order to take account of scientific developments and results from the examination of any of the information referred to in Articles 7, 10.4 and 14 of Directive 98/8/EC. Such adaptations will be examined and Page 24 of 51

25 finalised in connection with any amendment of the conditions for the inclusion of Icaridin in Annex I to the Directive. Page 25 of 51

26 Appendix I: List of endpoints Chapter 1: Identity, Physical and Chemical Properties, Classification and Labelling Active substance (ISO Common Name) Product-type Icaridin 19 Repellents and attractants Identity Chemical name (IUPAC) (RS)- sec-butyl 2-(2-hydroxyethyl)piperidine-1- carboxylate Chemical name (CA) CAS No EC No Other substance No. CIPAC No Piperidinecarboxylic acid, 2-(2-hydroxyethyl)-1- methylpropylester Minimum purity of the active substance as manufactured (g/kg or g/l) Identity of relevant impurities and additives (substances of concern) in the active substance as manufactured (g/kg) 97% The identity of the impurities of Icaridin is confidential. This information is provided in the confidential part of the dossier. Molecular formula C 12 H 23 NO 3 Molecular mass Structural formula g/mol HO H 3 C O N CH 3 O Page 26 of 51

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