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262User Guide for Thresholds and ClassificationsAppendix 17A: Acceptable test methods for specific targetorgan toxicity (single or repeated exposure)17A.1 IntroductionMost of the guidelines mentioned in this appendix are found in compilations from the organisation issuingthem. The guidelines listed below are not exclusive. If data have been generated using other validinternational guidelines, then the results from those tests may also be applicable.The main references to international guidelines referred to in this appendix are as follows.European Commission (EC) guidelines:European Commission 1996. Classification, Packaging and Labelling of Dangerous Substances in theEuropean Union. Part 2 – Testing Methods. http://ecb.jrc.it/testing-methods Retrieved 14 August 2007.Organisation for Economic Co-operation and Development (OECD) guidelines:OECD 1993. OECD Guidelines for the Testing of Chemicals. Organisation for Economic Co-operationand Development, Paris, with regular updates.http://www.oecd.org/document/40/0,3343,en_2649_34377_37051368_1_1_1_1,00.html Retrieved 14August 2007.United States Environmental Protection Agency (USEPA) Office of Prevention, Pesticides and ToxicSubstances (OPPTS) guidelines:USEPA 2007. Harmonized Test Guidelines. United States Environmental Protection Agency.http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm Retrieved 3 November 2011.17A.2 Specific target organ toxicity test guidelinesThe guidelines in Table 17A.1 are primarily relevant to substances that are, or solely contain, chemicalsubstances. However, the Hazardous Substances and New Organisms Act 1996 also covers biopesticidesthat include micro-organisms. More specialised test methods may be required to adequately characterise thepotential effects of biopesticides in mammals.For testing microbial biopesticides, see the USEPA website for specific tests.USEPA 2007. OPPTS Harmonized Test Guidelines: Series 885 Microbial Pesticide Test Guidelines –Final Guidelines. Office of Prevention, Pesticides and Toxic Substances, United States EnvironmentalProtection Agency. http://www.epa.gov/ocspp/pubs/frs/home/guidelin.htm Retrieved 3 November 2011..See also Table 17A.1.January 2012 EPA0109
263User Guide for Thresholds and ClassificationsTable 17A.1: Specific target organ toxicity (single or repeated exposure) test guidelines for chemicals, includingmixturesTest protocolsTest guidelineOECDECUSEPAOPPTSChronic toxicity 452 EC B.30 Chronic toxicity test 870.4100Combined chronic toxicity andcarcinogenicity453EC B.33 Combined chronic toxicity/carcinogenicitytest870.430090-day oral toxicity 408EC B.26 Subchronic oral toxicity test: repeateddose 90-day study in rodents870.3100Subchronic non-rodent oraltoxicity409EC B.27 Subchronic oral toxicity test: repeateddose 90-day study in non- rodents870.3150Repeated dose oral toxicity –28 daysRepeated dose dermal toxicity– 28 days407 EC B.7 Repeated dose (28 days) toxicity (oral) 870.3050410 EC B.9 870.3200Repeated dose inhalationtoxicity – 28 days412EC B.8 Repeated dose (28 days) toxicity(inhalation)–Subchronic dermal toxicity 411Subchronic inhalation toxicity 413EC B.28 Subchronic dermal toxicity test: 90-dayrepeated dermal dose study using rodent speciesEC B.29 Subchronic inhalation toxicity test: 90-day repeated dermal dose study using rodentspecies870.3250870.3465Delayed neurotoxicity oforganophosphoroussubstances – acute and 28 day418419EC B.37 Delayed neurotoxicity oforganophosphorus substances following acuteexposureEC B.38 Delayed neurotoxicity oforganophosphorus substances 28-day repeateddose study870.6100Neurotoxicity screening battery – – 870.6200Developmental neurotoxicitystudySchedule-controlled operantbehaviour– – 870.6300– – 870.6500Peripheral nerve function – – 870.6850Neurophysiology: sensoryevoked potentials– – 870.6855Companion animal safety – – 870.7200January 2012 EPA0109
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