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CA-Sept12-Doc.3.7a-rev1 Directive 98/8/EC concerning the placing biocidal products on the market Inclusion of active substances in Annex I to Directive 98/8/EC Assessment Report Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type (Wood preservative) September 2012 Annex I –Italy Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type September 2012 Alkyl (C12-16) dimethylbenzyl ammonium chloride (PT 8) Finalised in the Standing Committee on Biocidal Products at its meeting on 21 September 2012 in view of its inclusion in Annex I to Directive 98/8/EC CONTENTS STATEMENT OF SUBJECT MATTER AND PURPOSE 1.1 Procedure followed 1.2 Purpose of the assessment report 1.3 Overall conclusion in the context of Directive 98/8/EC OVERALL SUMMARY AND CONCLUSIONS 2.1 Presentation of the Active Substance 2.1.1 Identity, Physico-Chemical Properties & Methods of Analysis 2.1.2 Intended Uses and Efficacy 12 2.1.3 Classification and Labelling 14 2.2 Summary of the Risk Assessment 16 2.2.1 Human Health Risk Assessment 16 2.2.1.1 Hazard identification 16 2.2.1.2 Effects assessment 17 2.2.1.3 Exposure assessment 18 2.2.1.4 Risk characterization for local effects 26 2.2.2 Environmental Risk Assessment 37 2.2.2.1 Fate and distribution in the environment 37 2.2.2.2 Effects assessment 40 2.2.2.3 PBT assessment 42 2.2.2.4 Exposure assessment 43 2.2.2.5 Risk characterisation 46 DECISION 50 3.1 Background to the Proposed Decision 50 3.2 Proposed Decision regarding Inclusion in Annex I 52 3.3 Elements to be taken into account by Member States when authorising products 53 Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type September 2012 3.4 Requirement for further information 54 3.5 Updating this Assessment Report 55 APPENDIX I: LIST OF END POINTS 56 Chapter 1: Identity, Physical and Chemical Properties, Details of Uses, Further Information, and Proposed Classification and Labelling 56 Chapter 2: Methods of Analysis 59 Chapter 3: Impact on Human Health 60 Chapter 4: Fate and Behaviour in the Environment 66 Chapter 5: Effects on Non-target Species 68 Chapter 6: Other End Points 70 APPENDIX II: LIST OF USES SUPPORTED BY AVAILABLE DATA 71 APPENDIX III: LIST OF STUDIES 72 Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type September 2012 STATEMENT OF SUBJECT MATTER AND PURPOSE 1.1 Procedure followed This assessment report has been established as a result of the evaluation of Alkyl (C12-16) dimethylbenzyl ammonium chloride as product-type (wood preservative), 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 market1, with a view to the possible inclusion of this substance into Annex I or IA to the Directive Alkyl (C12-16) dimethylbenzyl ammonium chloride (CAS no 68424-85-1) was notified as an existing active substance, by Lonza Cologne GmbH, Stepan Europe, Mason Europe Limited, hereafter referred to as the applicant, in product-type Commission Regulation (EC) No 2032/2003 of November 20032 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 5(2) of that Regulation, Italy 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 Alkyl (C12-16) dimethylbenzyl ammonium chloride as an active substance in Product Type was 28th March 2004, in accordance with Annex V of Regulation (EC) No 2032/2003 On 28th March 2004, the Italian Competent Authority received a dossier from the applicant The Rapporteur Member State accepted the dossier as complete for the purpose of the evaluation on 28th September 2004 On 27th June 2005 the time period was suspended and the evaluation taken up again on 27th March 2006 after the applicant has submitted the necessary data After that, the evaluation phase was suspended again on the 17th July 2006 and taken up on 18th July 2007 On 31st July 2007, the Rapporteur Member State submitted, in accordance with the provisions of Article 10(5) and (7) of Regulation (EC) No 2032/2003, 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 19th 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, 24.4.98, p.1 Commission Regulation (EC) No 2032/2003 of November 2003 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 and amending Regulation (EC) No 1896/2000 OJ L 307, 24.11.2003, p Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type September 2012 September 2007 The competent authority report included a recommendation for the inclusion of Alkyl (C12-16) dimethylbenzyl ammonium chloridein Annex I to the Directive for PT In accordance with Article 12 of Regulation (EC) No 2032/2003, the Commission made the competent authority report publicly available by electronic means on 10th October 2007 This report did not 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 Alkyl (C12-16) dimethylbenzyl ammonium chloridein Annex I to Directive 98/8/EC and consulted the Standing Committee on Biocidal Product on 21 September 2012 In accordance with Article 11(4) of Regulation (EC) No 2032/2003, the present assessment report contains the conclusions of the Standing Committee on Biocidal Products, as finalised during its meeting held on 21 September 2012 1.2 Purpose of the assessment report This assessment report has been developed and finalised in support of the decision to include Alkyl (C12-16) dimethylbenzyl ammonium chloridein Annex I to Directive 98/8/EC for producttype The aim of the assessment report is to facilitate the authorisation in Member States of individual biocidal products in product-type that contain Alkyl (C12-16) dimethylbenzyl ammonium chloride In their evaluation, Member States shall apply the provisions of Directive 98/8/EC, in particular the provisions of Article 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 website3, 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 1.3 Overall conclusion in the context of Directive 98/8/EC http://ec.europa.eu/comm/environment/biocides/index.htm Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type September 2012 The overall conclusion from the evaluation is that it may be expected that there are products containing Alkyl (C12-16) dimethylbenzyl ammonium chloridefor the product-type 8, which will fulfil the requirements laid down in Article 10(1) and (2) 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 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 scenario 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 Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type September 2012 OVERALL SUMMARY AND CONCLUSIONS 2.1 Presentation of the Active Substance 2.1.1 Identity, Physico-Chemical Properties & Methods of Analysis Identification of the active substance CAS No EINECS No Other substance No.: IUPAC Name Common name, synonyms Chemical name (CA) Molecular formula Structural formula 68424-85-1 270-325-2 None assigned Not applicable Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides; ADBAC Alkylbenzyldimethylammonium Chloride Alkyl(C12-16)dimethylbenzylammonium chlorides Ammonium, alkyl(C12-C16)dimethylbenzyl-, chlorides Benzyl-C12-C16-alkyldimethyl ammonium chlorides Quaternary ammonium compounds, benzyl-C12-16-alkyldimethyl, chlorides C9 H13 N Cl R where R = C12 H25, C14 H29 or C16 H33 Cl- R N+ Alkyl chain lengths distribution Molecular weight (g/mol) Purity Impurities R = C 12 H 25 C 14 H 29 C 16 H 33 Chain Length C12 C14 C16 Specification for 68424-85-1(§) 39 - 75% 20 - 52% < 12% Typical Analysis of a Commercial Product 41.82% 48.43% 9.51% 340.0 – 396.1 g/mol (Avg = 359.6 g/mol) 94 − 99% w/w dry weight (*) See Confidential Data The active substance Alkyl (C12-16) dimethylbenzyl ammonium chloride (C12-16-ADBAC) does not contain additives or impurities that would be of toxicological/environmental concern (§) In May 2011 the RMS agreed with the amendment proposed by the joint Notifiers as regards the alkyl chain lengths distribution of the active substance This amendment, reflecting the complexity of the raw materials and processes used in their manufacture, can be considered as a negligible change, which does not affect the overall assessment of the active substance for both human and environmental health that has been conducted so far Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type September 2012 (*) The active substance is not manufactured solvent-free but always exists in process solvents Identification of the representative product Trade name Manufacturers development code number Active substance BQ-25 Not assigned Quaternary ammonium compounds, benzyl-C1216-alkyldimethyl, chlorides 25% (a.s 94 − 99%) Fungistatic, insecticide Liquid Solution Content of the active substance Function Physical state of preparation Nature of preparation The product does not contain substances of concern Physico-chemical properties The active substance Alkyl (C12-16) dimethylbenzyl ammonium chloride (C12-16-ADBAC) is a light beige solid which decomposes above 150°C before melting Its relative density was determined to be 0.96 at 20 °C Its vapour pressure was calculated to be 6.03E-04 Pa at 20°C, 8.5E-04 at 25°C and 4.22E-03 at 50°C, with a Henry’s Law constant of 5.03E-07 Pa m3 mol –1 at 20°C C12-16-ADBAC is highly soluble in water (water solubility at 20°C is 409 g/l at pH 5.5; 431 g/l at pH 6.5; 379 g/l at pH 8.2) Furthermore, it is readily soluble in Ethanol (>250 g/l at 20°C), Isopropanol (>250 g/l at 20°C) and Octanol (>250 m/l at 20°C) The partition coefficient n-octanol/water is not determinable since the active substance is a surfactant in the octanol/water system, thus preventing the use of the shake-flask method The HPLC Method is not applicable either, due to the absence of suitable calibration compounds and to the fact that ionic compounds interact with the HPLC column by forces other than partitioning Also the log Pow assessment by KOWWIN is deemed inaccurate, being the software database very limited for surface active substances On the other hand, log Pow could be roughly obtained from solubility in n-octanol and water (Pow ≈ 1, log Pow ≈ 0) However, this result is of no use with regard to environmental fate and behaviour and secondary poisoning risk assessment, since there is an experimental BCF available C12-16-ADBAC does not exhibit hazardous physico-chemical properties The substance is thermally stable, is not classified as highly flammable and does not show explosive or oxidising properties C12-16-ADBAC has a low vapour pressure and is highly soluble in water There is no risk to be expected due to the physico-chemical properties of the product BQ-25, either Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type September 2012 Analytical methods Analysis of the active substance as manufactured The Applicant proposed a method in which the quaternary ammonium content was determined using a biphasic competitive titration between reagent water and chloroform with bromophenol blue indicator The titrant, sodium tetraphenylborate (STPB), was standardized before being used to titrate triplicate 1:1:1 solutions of mg/ml aqueous ADBAC Quat 80%, pH 10 phosphate buffer and chloroform containing indicator Gas chromatography with flame ionization detection (GC-FID) was used to determine the distribution of the alkyl chain lengths of Alkyl Dimethyl Benzyl Ammonium Chloride The test substance was diluted in isopropanol to yield solutions of 126 and 123 mg/ml which were injected (1μl) onto the GC Following peak assignment relative to reference chromatograms, the alkyl chain lengths distribution was calculated assuming relative response coefficients of unity for duplicate analyses The requirements stated in TNsG Chapter Section 4.1 were not accomplished No data concerning recovery rates, linearity, limit of determination, specificity and intra-laboratory repeatability were available A suitable method was requested An additional analytical method (“Kurz M and Ranft V (2007) “Determination of quaternary ammonium compounds and related quaternary impurities by HPLC-ELSD”, Section 4.1(2) Doc IIIA) was submitted at the mid-July 2007 The method was not deemed acceptable, due to the deficiencies/mistakes affecting both the validation work and the original study report Hence, the RMS required the full validation of the developed method for both C12-16-ADBAC and impurities > 0.1% w/w, in compliance with SANCO/3030/99 rev.4 11/07/00 Anyway, at the TMIV08 it was concluded that the HPLC-ELSD method could be considered acceptable for C12-16-ADBAC It was also agreed that the Applicant should have provided further information on the analytical method and considered the possibility to use of an internal standard for quantitative analysis as suggested by AT In 2011, a new study (Zehr, P.S (2010), “Methods Validation for the Preliminary Characterization Analyses of Alkyldimethyl[ethyl]benzyl Ammonium Biocides”) for the determination of the active substance C12-16-ADBAC, impurities and process solvents in commercially available technical concentrate Maquat MC1412-50% (nominal active substance content: 50% w/w) was submitted, superseding Doc IIIA Sections 4.1(1) and (2) Results are now summarized in Section 4.1(3)(a) in Doc IIIA and Section 4.1(3)(b)-(c) in the Confidential Data Except for one impurity, valid analytical methods are available for impurities and process solvents in 50% w/w C12-16-ADBAC-based technical concentrate; additional information/clarification must be provided in any case (please refer to the RMS comments/requests in the evaluation box of the relevant study summaries) Following the submission of Zehr, P.S (2010), in April 2011 an additional study addressing batch-analysis (Dung Truong, M.S (2011), “Batch analysis of Alkyl(C12-16)dimethylbenzyl Ammonium Chlorides”) was presented Only two batches per Notifier have been investigated, whereas the TNsG for on the assessment of technical equivalence of substances regulated under 98/8/EC require the analytical profile of at least five different representative batches of each source for the purpose of Tier I assessment In conclusion, a new five-batch analysis for each Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type September 2012 source of the active substance must be submitted to allow the assessment of the technical equivalence of the three joint Notifiers supporting C12-16-ADBAC and also to confirm the active substance specification under Sec Doc IIIA Data should be submitted to the RMS prior to product authorization phase at national level Residues As regards the analysis of C12-16-ADBAC residues, LC-MS methods have been used in soil and water (drinking-, ground- and surface water) with a LOQ of 0.01 mg/kg and 0.1 μg/l as total C12-16-ADBAC, respectively Only one mass fragment related to C12-ADBAC was used for the purpose of validation During the evaluation of the Dossier in 2006, these methods were considered sufficiently specific, linear, accurate and precise by the RMS and were therefore accepted At that time, the Addendum to TNsG on Data Requirements Analytical Methods (based on SANCO/825/00) had not been endorsed yet and the conclusion on the specificity of the methods had been drawn by the RMS on the following grounds: - no further fragmentation was likely to occur under the LC-MS experimental conditions adopted; - the chromatograms of untreated matrices showed no interferences; - the m/z of the ion monitored ([C12-ADBA]+, m/z = 304.3) was sufficiently high that in the RMS opinion LC-MS could be reasonably considered specific enough On the contrary, the Addendum (adopted in May 2009) states that a confirmatory method is not necessary in case of a highly specific technique, which means the use of three fragment ions (possibly with m/z ratio >100) when MS detection is carried out So, according to the Addendum, the available data (given for one LC-MS ion only) are not actually sufficient to prove the specificity of the submitted methods, which are necessary for post-authorization control and monitoring purposes Furthermore, a bilateral discussion with DE occurred in 2010 on analogous LC-MS analytical methods for residues in soil and water for structurally-related quaternary ammonium compounds, with only one mass fragment (instead of three) validated It was agreed that highly specific confirmatory methods for residues in soil and water were necessary and were to be submitted for the product authorization phase at national level The same position (i.e the request for additional validation data) has been recently agreed with DE-CA in the commenting step for the very same substance (CAS 68424-85-1) notified by another Applicant In that case, LC/MS-MS analytical methods for residues in soil and water (both drinking- and surfacewater) were available, with only one mass transition (instead of two) validated In conclusion, in line with the Addendum to TNsG on Data Requirements Analytical Methods and also for the sake of consistency with the approach adopted for structurally-related quaternary ammonium compounds and for the same active substance notified by another Applicant, additional highly-specific confirmatory methods for C12-16-ADBAC residues in soil and water (both drinking- and surface-water) are to be submitted at the product authorization phase at national level No analytical method is required for the determination of residues in air, since the a.s is nonvolatile and will not be used in spray application 10 Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type September 2012 Biodegradability (LON 2302) Roy F Weston, Inc., Lionville, PA, USA Report No.91-066 (unpublished) 7.1.1.2.1(5) – Ready Biodegradability A113 (LON 3960) 7.1.2.1.1(1) – Aerobic biodegradation A101 (LON 3438) Van Dievoet, F and V Bouillon (2005) Biodegradability test report according to OECD 301 B – Modified BfB Oil Research S.A Report No ST49132.01.01 (unpublished) Schaefer, E.C (2001) Didecyldimethylammoniumchloride (DDAC): Die away in Activated Sludge Wildlife International Inc., Easton, MA, USA Project No 289E-112 (unpublished) Daly, D and W Cranor (1989) Anaerobic aquatic metabolism of alkyl dimethyl benzyl ammonium chloride Analytical Bio-Chemistry Laboratories, Inc., Columbia, MO, USA Report No 35714 (unpublished) Daly, D and W Cranor (1988) Aerobic aquatic metabolism of alkyl dimethyl benzyl ammonium chloride Analytical BioChemistry Laboratories, Inc., Columbia, MO, USA Report No 35715 (unpublished) Other Non-Key A64, A64a Biodegradability (LON 1868) Report(s) Included in This Submission A63 (LON 1869) A67 (LON 3375) A84 (LON 1102) 7.2.3.1 – Adsorption and desorption A43 (LON 1867) 7.4.1.1(1)– Acute toxicity to A8a fish (LON 1865) (Lepomis macrochirus) 7.4.1.1(2)– Acute toxicity to A6 fish (LON 3476) (Pimephales promelas) 7.4.1.1(3)– Acute toxicity to A7 fish (LON 3477) (Pimephales promelas) 7.4.1.1(4)– Acute toxicity to A8 de Vette, H.Q.M and J.G van Austen (2001) A water/ sediment degradation study of alkyldimethylbenzyl ammonium chloride (ADBAC) using [14C]ADBAC TNO Chemistry, Department of Environmental Toxicology, Delft, The Netherlands Report No V99.1172 (unpublished) Fisher, J.D (1971) Dissipation study of Hyamine 3500 in soil and its effects on microbial activity Rohm & Haas Company, Philadelphia, PE, USA Report No (unpublished) Daly, D and W Cranor (1988) Soil/sediment adsorptiondesorption of alkyl dimethyl ammonium chloride Analytical Bio-Chemistry Laboratories, Inc., Columbia, MO, USA Report No 35716 (unpublished) Pate, H.O and D.O McIntyre (1991) Daily static-renewal acute 96-hour toxicity test of alkyl dimethyl benzyl ammonium chloride (ADBAC) to bluegill sunfish Battelle Columbus Division, Columbus, OH, USA Study No SC890050 (unpublished) Sword, M.C and L Stuerman (1994) Static-renewal acute toxicity of alkyl dimethyl benzyl ammonium chloride (ADBAC) to fathead minnow (Pimephales promelas) ABC Laboratories, Columbia, MO, USA Report No 41237 (unpublished) Sword, M.C and L Stuerman (1994) Static-renewal acute toxicity of alkyl dimethyl benzyl ammonium chloride (ADBAC) to fathead minnow (Pimephales promelas) in dilution water amended with 10 mg/L humic acid ABC Laboratories, Columbia, MO, USA Report No 41236 (unpublished) Sword, M.C and L Stuerman (1994) Static-renewal acute 78 Alkyl (C12-16) dimethylbenzyl ammonium chloride fish (Pimephales promelas) Product-type (LON 3478) September 2012 toxicity of alkyl dimethyl benzyl ammonium chloride (ADBAC) to fathead minnow (Pimephales promelas) in dilution water amended with 20 mg/L humic acid ABC Laboratories, Columbia, MO, USA Report No 41235 (unpublished) 7.4.1.1(5)– Acute toxicity to A8b fish (LON 1864) (Oncorhynchus mykiss) Pate, H.O and D.O McIntyre (1991) Daily static-renewal acute 96-hour toxicity test of alkyl dimethyl benzyl ammonium chloride (ADBAC) to rainbow trout Battelle Columbus Division, Columbus, OH, USA Study No SC890051 (unpublished) 7.4.1.1– Acute toxicity to fish (Cyprinodon variegatus) A5/5a (LON 3479) 7.4.1.1– Acute toxicity to fish (Lepomis macrochirus) A46 (LON 1104) 7.4.1.1– Acute toxicity to fish A47 (LON 1008) Sved, D.W., Swigert, J.P and G.J Smith (1992) A 96-hour static-renewal acute toxicity test with alkyl dimethyl benzyl ammonium chloride (ADBAC) in the sheepshead minnow (Cyprinodon variegatus) Wildlife International Ltd., Easton, MD, USA Project No 350A-102 (unpublished) Bevier Hasbruck Sleight III (1971) Acute toxicity of Hyamine 3500 to bluegill (Lepomis macrochirus) Bionomics Inc., Wareham, MA, USA Report No 350A-102 (unpublished) Binns, R and G.C Clark (1969) The acute toxicity to fish of Hyamine 3500 Huntingdon Research Centre Ltd., Huntingdon, Cambridgeshire, England Report No 2938/69/364 (unpublished) Pate, H.O and D.O McIntyre (1991) Daily static-renewal acute 48-hour toxicity test of alkyl dimethyl benzyl ammonium chloride (ADBAC) to Daphnia magna Battelle Columbus Division, Columbus, OH, USA Study No SC890052 (unpublished) Sved, D.W., Swigert, J.P and G.J Smith (1992) A 96-hour static-renewal acute toxicity test with alkyl dimethyl benzyl ammoniumchloride (ADBAC) in the saltwater mysid (Mysidopsis bahia) Wildlife International Ltd., Easton, MD, USA Project No 350A-101A (unpublished) 7.4.1.2– Acute toxicity to A68 invertebrates (Daphnia magna) (LON 0097) 7.4.1.2– Acute toxicity to A10, A10a invertebrates (Mysidopsis (LON 3798) bahia) 7.4.1.2– Acute toxicity to invertebrates (Crassostrea virginica) A9, A9a (LON 3797) 7.4.1.3– Growth inhibition test on algae (Selenastrum capricornutum) A48 (LON 3374) 7.4.1.3– Growth inhibition test A119 on algae (Skeletonema (LON 4000) costatum) Sved, D.W., Swigert, J.P and G.J Smith (1992) A 48-hour static acute toxicity test with alkyl dimethyl benzyl ammonium chloride (ADBAC) in embryo larvae of the eastern oyster (Crassostrea virginica) Wildlife International Ltd., Easton, MD, USA Project No 350A-103 (unpublished) Mayer, P., Oldersma, H and J.A Schoonmade (2001) Determination of the effect of alkyldimethylbenzylammonium chloride (ADBAC) on the growth of fresh water green alga Selenastrum capricornutum (OECD Guideline No 201and EU C.3) TNO Chemistry, Delft, The Netherlands Report No V99.1176 (unpublished) Desjardins, D., MacGregor, J.A and H.O Krueger (2005) A 96-hour toxicity test of alkyl dimethyl benzyl ammonium chloride (ADBAC; 40% C12, 50% C14, 10% C16; CAS RN 68424-85-1) with the marine diatom (Skeletonema costatum) Wildlife International Ltd., Easton, MD, USA Project No 79 Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type September 2012 350A-104 (unpublished) Mayer, P.H., Schoonmade J.A and A.O Hanstveit (2001) Screening of the effect of alkyldimethylbenzylammonium chloride on the respiration rate of activated cludge (OECD Guideline No 209) TNO Nutrition and Food Research, Delft, The Netherlands Report No V99.1151 (unpublished) 7.4.1.4(1) – Inhibition to microbiological activity A49 (LON 3324) 7.4.1.4(2) – Inhibition to microbiological activity A62 7.4.1.4 – Inhibition to microbiological activity A85 (LON 3090) 7.4.2(1)– Bioconcentration A45 (LON 1866) Fackler, P.H (1989) Bioconcentration and elimination of 14Cresidues by bluegill (Lepomis macrochirus) exposed to alkyl dimethyl benzyl ammonium chloride (ADBAC) Springborn Life Sciences, Inc., Wareham, MA, USA Report No 89-12921 (unpublished) 7.4.2(2)– Bioconcentration A86 (LON 1099) 7.4.3.2– Fish reproduction and growth rate (Pimphales promelas) A11 (LON 3219) Krzeminski, S.F (1971) The accumulation and elimination of Hyamine 3500 residues by fish (bluegill) Bristol Research Laboratories, Philadelphia, PA, USA Report No 23-42 (unpublished) McIntyre, D.O and H.O Pate (1992) Daily static-renewal early life stage toxicity test of alkyl dimethyl benzyl ammonium chloride (ADBAC) to fathead minnows Battelle Columbus Operations, Columbus, OH, USA Study No SC890057 (unpublished) 7.4.3.4 – Invertebrate reproduction and growth rate (Daphnia magna) A12 (LON 3220) 7.4.3.5.1– Effects on sediment dwelling organisms (Chironomus tentans) A13 (LON 3221) 7.4.3.5.2 Aquatic plant toxicity A120 (LON 4001) 7.5.1.1 – Inhibition to microbiological activity A87 (LON 3382) Corby, J.E (1992) Determination of the acute toxicity of chemicals and wastewaters to aquatic microorganisms Roy F Weston, Inc., Lionville, PA, USA Report No 91-062 (unpublished) Janßen, U (1989) Prüfung auf Bakterientoxizität n OECD 209 Belebtschlamm Respirationshemmtest Journal-Nr: 8.680 Dr U.Noack-Laboratorium Für Angewandte Biologie, Technologiezentrum, Hildesheim, Germany (unpublished) McIntyre, D.O and H.O Pate (1992) Daily static-renewal chronic 21-day toxicity test of alkyl dimethyl benzyl ammonium chloride (ADBAC) to Daphnia magna Battelle Columbus Operations, Columbus, OH, USA Study No SC890056 (unpublished) England, D.C and T Leak (1995) Chronic toxicity of sediment-incorporated ADBAC to Chironomus tentans ABC Laboratories, Inc., Columbia, MO, USA Report No 41004 (unpublished) Desjardins, D., J.A McGregor and H.O Krueger (2005) A 7Day Toxicity Test of Alkyl Dimethyl Benzyl Ammonium Chloride (ADBAC; 40% C12, 50% C14, 10% C16; CAS RN 68424-85-1) with Duckweed (Lemna gibba G3) Study No 350A-105 Wildlife International, Ltd (Unpublished) de Vette, H.Q.M., Hanstveit, R and J.A Schoonmade (2001) The assessment of the ecological effects of 80 Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type 7.5.1.2 – Acute toxicity test to earthworms A95 (LON 3799) 7.5.1.3 – Acute toxicity to plants A94 (LON 3800) 7.5.3.1.1 – Acute oral toxicity (Bobwhite quail ) A59 (LON 3801) 7.5.3.1.2(1) – Short-term toxicity A117 (LON 3997) 7.5.3.1.2(2) – Short-term toxicity A118 (LON 3999) Other Non-Key Report(s) Included in This Submission A103 (LON 3815) References Supporting Summaries Found in Document III-A, Section A104 A105 A106 September 2012 alkyldimethylbenzylammonium chloride (Guidelines OPPTS 850.5100 Soil Microbial Community Test, OECD 216 and OECD 217 and CTB Section H.4.1) TNO Chemistry, Delft, The Netherlands Report No V99.1170 (unpublished) Rodgers, M.H (2004) N-Alkyl (C12-16)-N,N-dimethylNbenzylammonium chloride (ADBAC): Acute toxicity (LC50) to the earthworm Huntingdon Life Sciences Ltd., Huntingdon, Cambridgeshire, England Report No ADB/023 033976 (unpublished) Gray, J (2004) N-Alkyl(C12-C16)-N,N-dimethylNbenzylammonium chloride (ADBAC): Acute toxicity to terrestrial plants Huntingdon Life Sciences Ltd., Huntingdon, Cambridgeshire, England Study No ADB/024 (unpublished) Campbell, S.M and M Jaber (1993) An acute oral toxicity study with alkyl dimethyl benzyl ammonium chloride (ADBAC) in the northern bobwhite quail Wildlife International Ltd., Easton, MD, USA Project No 289-109 (unpublished) Gallagher, S.P., Martin, K.H and J.B Beavers (2005) A dietary LC50 study with alkyl dimethyl benzyl ammonium chloride (ADBAC; 40% C12, 50% C14, 10% C16; CAS RN 68424-85-1) in the northern bobwhite Wildlife International Ltd., Easton, MD, USA Project No 350-101 (unpublished) Gallagher, S.P., Martin, K.H and J.B Beavers (2005) A dietary LC50 study with alkyl dimethyl benzyl ammonium chloride (ADBAC; 40% C12, 50% C14, 10% C16; CAS RN 68424-85-1) in the mallard Wildlife International Ltd., Easton, MD, USA Project No 350-102 (unpublished) Bestari, K (2001) Determination of the leachability of Bardac 2280 from treated wood Centre for Toxicology, University of Guelph, Guelph, Ontario, Canada Study No 2000-CT-WL-B22 (unpublished) Linfield, W.M (1969) In E Jungermann, Ed., “Cationic Surfactants”, Marcel Dekker, New York, N.Y Chapter 2, “Straight-Chain Alkylammonium Compounds, pages 9-70 Preston, A.F., P.J Walcheski, P.A McKaig and D.D Nicholas (1987) Recent research on alkylammonium compounds in the U.S Proc Am Wood Pres Assn 83, 331-347 (published) Wazny, J and R Rudniewski (1997) Fungitoxic effect of the quaternary ammonium compounds wood preservatives against Basidiomycetes by using agar-plate and agar-block methods International Research Group on Wood Preservation Document No IRG/WP/96-30118 81 Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type A107 A108 September 2012 Tang, H and J.N Ruddick (1994) Evaluating the potential of amine chemicals for use as wood protecting agents Part 1: Investigation of cation component of quaternary ammonium compounds International Research Group on Wood Preservation Document No IRG WP 94-30049 Tsunoda, K (1990) Effect of alkyl chain length on the fungicidal efficacy of benzalkonium chlorides J Antibact Antifung Agents 18(4), 185-189 (published) 82 Alkyl (C12-16) dimethylbenzyl ammonium chloride Product-type September 2012 Document IIIB Endpoint Reference No 3.5(1) – Acidity/alkalinity and A122 if (LON 4004) necessary pH value (1% in water) Reference Non-Key Studies are italicized Sydney, P (2006) BQ-25: Physicochemical properties Huntingdon Life Sciences Ltd., Hungtingdon, Cambdridgeshire, England Report No ADB0031/062228 (unpublished) 3.6(1) – Relative Density A122 (LON 4004) 3.8(1) – Technical characteristics of the biocidal product: Persistent foaming A122 (LON 4004) 3.10.2(1) – Viscosity A122 (LON 4004) References Supporting Summaries Found in Document III-B, Section A107 Sydney, P (2006) BQ-25: Physicochemical properties Huntingdon Life Sciences Ltd., Hungtingdon, Cambdridgeshire, England Report No ADB0031/062228 (unpublished) Sydney, P (2006) BQ-25: Physicochemical properties Huntingdon Life Sciences Ltd., Hungtingdon, Cambdridgeshire, England Report No ADB0031/062228 (unpublished) Sydney, P (2006) BQ-25: Physicochemical properties Huntingdon Life Sciences Ltd., Hungtingdon, Cambdridgeshire, England Report No ADB0031/062228 (unpublished) Tang, H and J.N Ruddick (1994) Evaluating the potential of amine chemicals for use as wood protecting agents Part 1: Investigation of cation component of quaternary ammonium compounds International Research Group on Wood Preservation Document No IRG WP 94-30049 Tsunoda, K (1990) Effect of alkyl chain length on the fungicidal efficacy of benzalkonium chlorides J Antibact Antifung Agents 18(4), 185-189 (published) Tsunoda, K and K Nishimoto (1987) Effectiveness of alkylammonium compounds as above-ground wood preservatives Mokuzai Gakkaishi, 33 (7), 589-595 (published) Tsunoda, K and K Nishimoto (1983) Fungicidal and termicidal effectiveness of alkylammonium compounds International Research Group on Wood Preservation Document No IRG WP 3232 A108 A109 A110 83 Quaternary ammonium compounds, benzyl-C12-16alkyldimethyl, chlorides Product-type Appendix IV: List of standard terms and abbreviations Stand term Abbreviation A ACh AChE ADBAC ADI ADME ADP AE AF AFID A/G ALD50 ALT Ann AOEL AMD ANOVA AP approx ARC ARfD as AST ASV ATP BAF BCF bfa BOD bp BPD BSAF BSE BSP BUN bw c °C CA CAD cd CDA cDNA CEC / Explanation Ampere Acetylcholine Acetylcholinesterase Alkyldimethylbenzylammonium Chloride acceptable daily intake administration distribution metabolism and excretion adenosine diphosphate acid equivalent assessment factor alkali flame-ionisation detector or detection albumin/globulin ratio active ingredient approximate median lethal dose, 50% alanine aminotransferase (SGPT) Annex acceptable operator exposure level automatic multiple development analysis of variance alkaline phosphatase Approximate anticipated residue contribution acute reference dose active substance aspartate aminotransferase (SGOT) air saturation value adenosine triphosphate bioaccumulation factor bioconcentration factor body fluid assay biological oxygen demand boiling point Biocidal Products Directive biota-sediment accumulation factor bovine spongiform encephalopathy bromosulfophthalein blood urea nitrogen body weight centi- (x 10 –2 ) degrees Celsius (centigrade) controlled atmosphere computer aided design candela controlled drop(let) application complementary DANN cation exchange capacity 84 September 2012 Quaternary ammonium compounds, benzyl-C12-16alkyldimethyl, chlorides Stand term Abbreviation cf CFU ChE CI CL cm CNS COD Conc CPK cv Cv d DDAC DES DIS DMSO DNA dna DO DOC dpi DRP DT50(lab) DT90(field) dw DWQG ε EASE EC50 ECD ED50 EDI EINECS ELINCS ELISA e-mail EMDI EN EPMA ERL ESD ESPE46/51 EUSES F F0 F1 Product-type September 2012 / Explanation confer, compare to colony forming units cholinesterase confidence interval confidence limits centimetre central nervous system chemical oxygen demand Concentration creatinine phosphatase coefficient of variation ceiling value day(s) Didecyldimethylammonium Chloride diethylstilboestrol draft international standard (ISO) dimethylsulfoxide deoxyribonucleic acid designated national authority dissolved oxygen dissolved organic carbon days post inoculation detailed review paper (OECD) period required for 50 percent dissipation (under laboratory conditions) (define method of estimation) period required for 90 percent dissipation (under field conditions) (define method of estimation) dry weight drinking water quality guidelines decadic molar extinction coefficient Estimation and Assessment of Substance Exposure median effective concentration electron capture detector median effective dose estimated daily intake European inventory of existing commercial substances European list of notified chemical substances enzyme linked immunosorbent assay electronic mail estimated maximum daily intake European norm electron probe micro-analysis extraneous residue limit Emission Scenario Document evaluation system for pesticides European Union system for the evaluation of substances Field parental generation filial generation, first 85 Quaternary ammonium compounds, benzyl-C12-16alkyldimethyl, chlorides Stand term Abbreviation F2 FBS FELS FIA FID Fmol FOB foc fp FPD FPLC g gd GAP GC GC-EC GC-FID GC-MS GC-MSD GEP GFP GGT GI GIT GL GLC GLP GM GMO GMM GPC GPS GSH GV h H Hb HC5 HCG Hct HDT hL HEED HID HPAEC HPLC Product-type September 2012 / Explanation filial generation, second full base set fish early-life stage fluorescence immuno-assay flame ionisation detector fractional equivalent of the metabolite´s molecular weight compared to the active substance functional observation battery organic carbon factor (compartment dependent) freezing point flame photometric detector fast protein liquid chromatography gram(s) gestation day good agricultural practice gas chromatography gas chromatography with electron capture detector gas chromatography with flame ionisation detector gas chromatography-mass spectrometry gas chromatography with mass-selective detection good experimental practice good field practice gamma glutamyl transferase gastro-intestinal gastro-intestinal tract guideline level gas liquid chromatography good laboratory practice geometric mean genetically modified organism genetically modified micro-organism gel-permeation chromatography global positioning system Glutathione Granulosevirus hour(s) Henry’s Law constant (calculated as a unitless value) hectare(s) Haemoglobin concentration which will be harmless to at least 95 % of the species present with a given level of confidence (usually 95 %) human chorionic gonadotropin Haematocrit highest dose tested Hectolitre high energy electron diffraction helium ionisation detector high performance anion exchange chromatography high pressure liquid chromatography or high performance liquid 86 Quaternary ammonium compounds, benzyl-C12-16alkyldimethyl, chlorides Stand term Abbreviation HPLC-MS HPPLC HPTLC HRGC HS Ht HUSS I I50 IC50 ICM ID IEDI IGR im inh INT ip IPM IR ISBN ISSN IUCLID iv IVF k (in combination) k K Ka Kb Kads Kdes kg KH Koc Kom Kow Kp kPa l, L LAN LASER LBC LC LC-MS LC50 LCA LC-MS-MS Product-type September 2012 / Explanation chromatography high pressure liquid chromatography - mass spectrometry high pressure planar liquid chromatography high performance thin layer chromatography high resolution gas chromatography Shannon-Weaver index Haematocrit human and use safety standard Indoor inhibitory dose, 50% median immobilisation concentration or median inhibitory concentration integrated crop management ionisation detector international estimated daily intake insect growth regulator intramuscular inhalation 2-p-iodophenyl-3-p-nitrophenyl-5-phenyltetrazoliumchloride testing method intraperitoneal integrated pest management infrared international standard book number international standard serial number International Uniform Chemical Information Database intravenous in vitro fertilisation kilo rate constant for biodegradation Kelvin acid dissociation constant base dissociation constant adsorption constant apparent desorption coefficient kilogram Henry´s Law constant (in atmosphere per cubic metre per mole) organic carbon adsorption coefficient organic matter adsorption coefficient octanol-water partition coefficient solid-water partition coefficient kilopascal(s) litre local area network light amplification by stimulated emission of radiation loosely bound capacity liquid chromatography liquid chromatography- mass spectrometry lethal concentration, median life cycle analysis liquid chromatography with tandem mass spectrometry 87 Quaternary ammonium compounds, benzyl-C12-16alkyldimethyl, chlorides Stand term Abbreviation LD50 LDH ln LOAEC LOAEL LOD LOEC LOEL log LOQ LPLC LSC LSD LSS LT m M µm MAC MAK MC MCH MCHC MCV MDL MFO µg mg MHC MIC MKC mL MLT MLD mm MMAD mo MOE mol MOS mp MRE MRL mRNA MS MSDS MTD MT Product-type / Explanation lethal dose, median; dosis letalis media lactate dehydrogenase natural logarithm lowest observable adverse effect concentration lowest observable adverse effect level limit of detection lowest observable effect concentration lowest observable effect level logarithm to the base 10 limit of quantification (determination) low pressure liquid chromatography liquid scintillation counting or counter least squared denominator multiple range test liquid scintillation spectrometry lethal threshold Metre Molar micrometre (micron) maximum allowable concentration maximum allowable concentration moisture content mean corpuscular haemoglobin mean corpuscular haemoglobin concentration mean corpuscular volume method detection limit mixed function oxidase microgram milligram moisture holding capacity minimum inhibitory concentration minute(s) minimum killing concentration millilitre median lethal time minimum lethal dose millimetre mass median aerodynamic diameter month(s) margin of exposure mole(s) margin of safety melting point maximum residue expected maximum residue level or limit messenger ribonucleic acid mass spectrometry material safety data sheet maximum tolerated dose material test 88 September 2012 Quaternary ammonium compounds, benzyl-C12-16alkyldimethyl, chlorides Stand term Abbreviation MW n.a nn NAEL nd NEDI NEL NERL ng nm NMR no, n° NOAEC NOAEL NOEC NOED NOEL NOIS NPD NPV NR NTE OC OCR ODP ODS OEL OH OJ OM Pa PAD 2-PAM pc PCV PEC PECA PECS PECSW PECGW PED pH PHED PIC pic PIXE pKa pKb Product-type September 2012 / Explanation molecular weight not applicable normal (defining isomeric configuration) number of observations no adverse effect level not detected national estimated daily intake no effect level no effect residue level Nanogram Nanometre nuclear magnetic resonance Number no observed adverse effect concentration no observed adverse effect level no observed effect concentration no observed effect dose no observed effect level notice of intent to suspend nitrogen-phosphorus detector or detection nuclear polyhedrosis virus not reported neurotoxic target esterase organic carbon content optical character recognition ozone-depleting potential ozone-depleting substances occupational exposure limit Hydroxide Official Journal organic matter content Pascal pulsed amperometric detection 2-pralidoxime paper chromatography haematocrit (packed corpuscular volume) predicted environmental concentration predicted environmental concentration in air predicted environmental concentration in soil predicted environmental concentration in surface water predicted environmental concentration in ground water plasma-emissions-detector pH-value pesticide handler’s exposure data prior informed consent phage inhibitory capacity proton induced X-ray emission negative logarithm (to the base 10) of the acid dissociation constant negative logarithm (to the base 10) of the base dissociation constant 89 Quaternary ammonium compounds, benzyl-C12-16alkyldimethyl, chlorides Stand term Abbreviation PNEC po POP ppb PPE ppm PPP ppq ppt PSP PrT PRL PT PT(CEN) PTDI PTT QA QAU (Q)SAR r r2 RA RBC REI RENI Rf RfD RH RL50 RNA RP rpm rRNA RRT RSD s S SAC SAP SAR SBLC sc sce SCAS SCTER SD se SEM SEP Product-type September 2012 / Explanation predicted no effect concentration (compartment to be added as subscript) by mouth persistent organic pollutants parts per billion (10-9 ) personal protective equipment parts per million (10-6 ) plant protection product parts per quadrillion (10-24 ) parts per trillion (10-12 ) phenolsulfophthalein prothrombin time practical residue limit product type project team CEN provisional tolerable daily intake partial thromboplastin time quality assurance quality assurance unit quantitative structure-activity relationship correlation coefficient coefficient of determination risk assessment red blood cell restricted entry interval Registry Nomenclature Information System retardation factor reference dose relative humidity median residual lifetime ribonucleic acid reversed phase revolutions per minute ribosomal ribonucleic acid relative retention time relative standard deviation Second Solubility strong adsorption capacity serum alkaline phosphatase structure/activity relationship shallow bed liquid chromatography Subcutaneous sister chromatid exchange semi-continuous activated sludge smallest chronic toxicity exposure ratio (TER) standard deviation standard error standard error of the mean standard evaluation procedure 90 Quaternary ammonium compounds, benzyl-C12-16alkyldimethyl, chlorides Stand term Abbreviation SF SFC SFE SIMS S/L SMEs SOP sp SPE SPF spp SSD SSMS STEL STER STMR STP t t½ T3 T4 T25 TADI TBC TCD TG TGD TID TDR TER TERI TERST TERLT tert TEP TGGE TIFF TLC Tlm TLV TMDI TMRC TMRL TNsG TOC Tremcard tRNA TSH TTC Product-type September 2012 / Explanation safety factor supercritical fluid chromatography supercritical fluid extraction secondary ion mass spectroscopy short term to long term ratio small and medium sized enterprises standard operating procedures species (only after a generic name) solid phase extraction specific pathogen free subspecies sulphur specific detector spark source mass spectrometry short term exposure limit smallest toxicity exposure ratio (TER) supervised trials median residue sewage treatment plant tonne(s) (metric ton) half-life (define method of estimation) tri-iodothyroxine thyroxine tumorigenic dose that causes tumours in 25% of the test animals temporary acceptable daily intake tightly bound capacity thermal conductivity detector technical guideline, technical group Technical guidance document thermionic detector, alkali flame detector time domain reflectrometry toxicity exposure ratio toxicity exposure ratio for initial exposure toxicity exposure ratio following repeated exposure toxicity exposure ratio following chronic exposure tertiary (in a chemical name) typical end-use product temperature gradient gel electrophoresis tag image file format thin layer chromatography median tolerance limit threshold limit value theoretical maximum daily intake theoretical maximum residue contribution temporary maximum residue limit technical notes for guidance total organic carbon transport emergency card transfer ribonucleic acid thyroid stimulating hormone (thyrotropin) 2,3,5-triphenylterazoliumchloride testing method 91 Quaternary ammonium compounds, benzyl-C12-16alkyldimethyl, chlorides Stand term Abbreviation TWA UDS UF ULV UR UV UVC UVCB v/v vis WBC wk wt w/v ww w/w XRFA yr < ≤ > ≥ Product-type September 2012 / Explanation time weighted average unscheduled DNA synthesis uncertainty factor (safety factor) ultra low volume unit risk Ultraviolet unknown or variable composition, complex reaction products undefined or variable composition, complex reaction products in biological material volume ratio (volume per volume) Visible white blood cell Week Weight weight per volume wet weight weight per weight X-ray fluorescence analysis year less than less than or equal to greater than greater than or equal to 92