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ReferencesECETOC (2003): (Q)SARs: evaluation of the commercially available software for humanhealth and environmental endpoints with respect to chemical management applications.Technical Report No. 89. European Centre for Ecotoxicology and Toxicology of Chemicals,Brussels.ECB (2003): Use of (Quantitaive) Structure Activity Relationships ((Q)SAR) in RiskAssessment, in: Technical Guidance Document on Risk Assessment in Support ofCommission Directive 93/67/EEC on Risk Assessment for new notified substances,Commission Regulation (EC) No. 1488/94 on Risk Assessment for existing substances,Directive 98/8/EC of the European Parliament and of the Council concerning the placing ofbiocidal products on the market, Part III, Chapter 4, European Commission, Joint ResearchCentre, Institute for Health and Consumer Protection, European Chemicals Bureau.Tennant RW and Ashby J (1991): Classification according to chemical structure,mutagenicity to Salmonella and level of carcinogenicity of a further 39 chemicals tested forcarcinogenicity by the US National Toxicology program. Mutation Research 257, 209-227.Ashby J and Tennant RW (1991): Definitive relationships among chemical structure,carcinogenicity and mutagenicity for 301 chemicals tested by the U.S. NTP. MutationResearch 257, 229-306.Van den Berg, M., et al (1998): Toxic Equivalency Factors (TEFs) for PCBs, PCDDs, PCDFsfor humans and wildlife. Environmental Health Perspective, 106 (12), 775-792.Van den Berg, M., et al. (2006): The 2005 World Health Organisation reevaluation of humanand mammalian toxic equivalency factors for dioxins and dioxin-like compounds.Toxicological Sciences, 93 (2), 223-241WHO/FAO (2010) Manual on development and use of FAO and WHO specifications forpesticides. November 2010 – second revision of the First Edition, Prepared by the FAO/WHOJoint Meeting on Pesticide Specifications (JMPS), available only on the internet WHO andFAO, RomeKroes R, Renwick AG, Cheeseman M, Kleiner J, Mangelsdorf I, Piersma A, Schilter B,Schlatter J, van Schothorst F, Vos JG, Wurtzen G (2004) Structure-based thresholds oftoxicological concern (TTC): guidance for application to substances present at low levels inthe diet. Food Chem Toxicol (42) 65-83Kroes R, Kleiner J, Renwick A (2005) The threshold of toxicological concern concept in riskassessment. Toxicol Sci (86) 226-230Finney, D.J. (1971): Probit Analysis, 3rd ed. Cambridge University Press, London.Kortenkamp, A., Backhaus, T., Faust, M. (2010): State of the Art Report on Mixture Toxicity.Report for the European Commission, DG Environment, Study Contract Number070307/2007/485103/ETU/D.1. Available online underhttp://ec.europa.eu/environment/chemicals/pdf/report_Mixture%20toxicity.pdf14
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Page 1 and 2: EUROPEAN COMMISSIONHEALTH AND CONSU
Page 3 and 4: 1 Implementing scheduleThis amended
Page 5 and 6: Significant impuritiesImpurities th
Page 7 and 8: 7.1.2 Evaluation processThe objecti
Page 9 and 10: If the answer is yes, it might be a
Page 11 and 12: a) Prediction of the expected incre
Page 13: Bridging across different media (e.
Page 17 and 18: 1. Ascertainment of the necessity t
Page 19 and 20: Appendix Ib: Evaluation and decisio
Page 21 and 22: Appendix III, which is based on a l
Page 23 and 24: tests with information provided on
Page 25 and 26: Appendix IV Guideline triggers for
Page 27 and 28: Appendix V How to judge what is an
Page 29 and 30: Appendix VI Example calculations fo
Page 31 and 32: TABLE OF CONTENTS1 STATEMENT OF THE
Page 33 and 34: A.4 MANUFACTURER’S DEVELOPMENT CO
Page 35 and 36: XXXXXXAccuracy:XXXXXXPrecisionXXXXX
Page 37: SUMMARY OF THE TECHNICAL EQUIVALENC

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