Didecyldimethylammonium chloride Europa

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Didecyldimethylammonium Product type 8 June 2015,1 STATEMENT OF SUBJECT MATTER AND PURPOSE 3. 1 1 Procedure followed 3,1 2 Purpose of the assessment report 4. 1 3 Overall conclusion in the context of Directive 98 8 EC 4. 2 OVERALL SUMMARY AND CONCLUSIONS 6,2 1 Presentation of the Active Substance 6. 2 1 1 Identity Physico Chemical Properties Methods of Analysis 6. 2 1 2 Intended Uses and Efficacy 10,2 1 3 Classification and Labelling 12. 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 20,2 2 1 4 Risk characterisation 24. 2 2 2 Environmental Risk Assessment 29, 2 2 2 1 Fate and distribution in the environment 29. 2 2 2 2 Effects assessment 32,2 2 2 1 PBT and POP assessment 37. 2 2 2 2 Exposure assessment 39,2 2 2 3 Risk characterisation 43.
2 2 3 Assessment of endocrine disruptor properties 46. 3 DECISION 48,3 1 Background to the Proposed Decision 48. 3 1 Proposed Decision regarding Inclusion in Annex I 49. 3 2 Elements to be taken into account by Member States when authorising products. 3 3 Requirement for further information 51,3 4 Updating this Assessment Report 51. APPENDIX II LIST OF INTENDED USES US ISC 91,APPENDIX II LIST OF INTENDED USES EQC 92. APPENDIX III LIST OF STUDIES 93,Didecyldimethylammonium Product type 8 June 2015. 1 STATEMENT OF SUBJECT MATTER AND PURPOSE,1 1 Procedure followed.
This assessment report has been established as a result of the evaluation of. didecyldimethylammonium chloride DDAC CAS no 7173 51 5 as product type 8 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, DDAC was notified as an existing active substance separately by Lonza AG Stepan Europe. Mason Europe Ltd US ISC and by Akzo Nobel and Thor European Quat Consortium EQC. hereafter referred to as the applicants in product type 8. Commission Regulation EC No 2032 2003 of 4 November 2003 2 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 didecyldimethylammonium. chloride as an active substance in Product Type 8 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 either applicant. The Rapporteur Member State accepted the dossiers as complete for the purpose of the. evaluation on 28th September 2004, As regards the US ISC 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 17 th 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 20th September 2007 The competent authority report included a recommendation for the. inclusion of didecyldimethylammonium chloride in Annex I to the Directive for PT 8. 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. 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 4 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 1,Didecyldimethylammonium Product type 8 June 2015.
didecyldimethylammonium chloride in 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, As regards Akzo Nobel and Thor European Quat Consortium EQC on 25th January 2005 the. evaluation was suspended After a meeting with EQC on 24th November 2005 focusing on. Identity and Physico chemical properties the Italian Competent Authority received a new. version of the dossier 26th January 2006 which however did not comply with RMS s requests. for revision The dossier was re submitted by the Applicant on 16th July 2007 whereas the. evaluation was taken up again on 15th October 2007 A further revision of the dossier was. presented by the Applicant on 14th March 2008 following a meeting on 13th December 2007. where the identity of the active substance was discussed again CA Sept06 Doc 6 1 2. CLARIFICATION ON SUBSTANCES NOTIFIED UNDER THE BKC AND DDAC GENERIC HEADINGS. IN ANNEX II OF COMMISSION REGULATION EC NO 2032 2003. Furthermore the combined LoEP for human health and environment was discussed and agreed. at WGII 2015 CA Nov14 Doc 5 15 Final Submission of applications for product authorisations. of PT08 products containing DDAC or ADBAC BKC,1 2 Purpose of the assessment report. This assessment report has been developed and finalised in support of the decision to include. didecyldimethylammonium chloride in Annex I to Directive 98 8 EC for product type 8 The. aim of the assessment report is to facilitate the authorisation in Member States of individual. biocidal products in product type 8 that contain didecyldimethylammonium chloride 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. 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. The overall conclusion from the evaluation is that it may be expected that there are products. containing didecyldimethylammonium chloride for 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. 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. http ec europa eu comm environment biocides index htm. Didecyldimethylammonium Product type 8 June 2015, 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. Didecyldimethylammonium Product type 8 June 2015,2 OVERALL SUMMARY AND CONCLUSIONS.
The data submitted by the two Applicants for the evaluation and approval of. didecyldimethylammonium chloride DDAC CAS no 7173 51 5 are reported in the following. chapters In particular Lonza AG Stepan Europe Mason Europe Ltd members of the. ADBAC and DDAC Issues Steering Committee and Akzo Nobel Thor members of the. European Quats Consortium are indicated as US ISC and EQC respectively. 2 1 Presentation of the Active Substance, 2 1 1 Identity Physico Chemical Properties Methods of Analysis. Identification of the active substance, Didecyldimethylammonium chloride DDAC is not manufactured solvent free but in process. solvents as technical concentrate in water or water alcohol. CAS No 7173 51 5,EINECS No 230 525 2,Other No 612 131 00 6 Annex I Index number. IUPAC Name N N Didecyl N N dimethylammonium chloride. CAS Name 1 Decanaminium N decyl N N dimethyl chloride. Molecular formula C22H48N Cl,Structural formula,R1 N CH3 Cl. where R1 R2 C10H21,Molecular weight 362 1 g mol,Purity 87 0 w w dry weight for US ISC.
97 9 w w dry weight for EQC, DDAC does not contain any additive nor any relevant impurity Only significant impurities are. present which are considered as confidential information by the two Applicants and hence. described in the Annex of Confidential data of the respective CARs. Identification of the representative product,Trade name BC 25. Manufacturers development code number None assigned. Active substance Didecyldimethylammonium chloride,Content of the a s g kg 250. Function Fungicide insecticide,Physical state of preparation Liquid. Nature of preparation Water based concentrate SL,Didecyldimethylammonium Product type 8 June 2015.
Trade name DDAC 50, Manufacture s development code number None assigned. Active substance Didecyldimethylammonium chloride,Content of the a s g kg 500. Function Fungicide fungistatic,Physical state of preparation Liquid. Nature of preparation Solvent based concentrate, Detailed qualitative and quantitative composition of the representative products including. identity content and function of non active ingredients is available in the Annex of. Confidential data of either CAR,Physico chemical properties.
DDAC is manufactured in process solvents as technical concentrate in water or water alcohol. For the purpose of physico chemical properties testing either US ISC and EQC prepared a. sample of technical material by removing process solvents as far as possible from a sample of. DDAC technical concentrate in water isopropanol and water respectively. DDAC is a white slight yellowish solid with hygroscopic behaviour and aromatic moderate. mushroom like odour Its relative density D420 is 0 9 DDAC is thermally stable non volatile. and highly soluble in water Water solubility was found to be independent of temperature and. pH DDAC is fully ionized in water, The partition coefficient n octanol water is not determinable by the use of the shake flask. method since DDAC is a surfactant The HPLC method is not applicable either due to the. absence of suitable calibration compounds and to the interaction of DDAC with the HPLC. column by forces other than partitioning Also the log Kow assessment by KOWWIN is deemed. inaccurate being the software database very limited for surface active substances On the. other hand log Kow can be roughly obtained from solubility in n octanol and water Kow 0 38. log Kow 0 41 according to EQC However this result is of no use with regard to. environmental fate behaviour and secondary poisoning risk assessment when there is an. experimental BCFfish available as for US ISC, UV VIS IR NMR absorption spectra and MS spectrum are found consistent with DDAC. molecular structure As for the UV VIS spectra no absorption is observed above 290 nm under. the investigated conditions neutral acidic basic medium. DDAC does not show explosive or oxidising properties DDAC is not classified as a flammable. solid either, BC 25 representative product for US ISC is a water based concentrate which is not expected. to pose any physical hazard, DDAC 50 representative product for EQC is a solvent based concentrate which is not. expected to have explosive or oxidising properties Auto ignition temperature is 260 C. whereas flash point is 26 C thus requiring the classification of the product as Flam Liq 3. according to CLP,Analytical methods,Analysis of the active substance as manufactured.
US ISC In 2011 a new study Zehr P S 2010 Methods Validation for the Preliminary. Characterization Analyses of Dialkyldimethyl Ammonium Chlorides for the determination of. DDAC impurities and process solvents in commercially available technical concentrate. didecyldimethylammonium chloride DDAC CAS no 7173 51 5 as product type 8 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 market 1 with a view to the possible inclusion of this substance into Annex I or IA to the

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