A Practical Approach, Second Edition=Ronald D. Ho.pdf

PERSPECTIVES ON THE DEVELOPMENTAL AND REPRODUCTIVE TOXICITY GUIDELINES 735Table 19.1Current regulatory guidelines — ICH, FDA, OECD, and EPARegulatory Agency Ref. GuidelineMedical AgentsICH 1 Detection of toxicity to reproduction for medicinal productsICH 19 Detection of toxicity to reproduction for medicinal productsFDA 2 International Conference on Harmonisation: guideline on detection of toxicity toreproduction for medicinal productsFDA 3 International Conference on Harmonisation: guideline on detection of toxicity toreproduction for medicinal products: Addendum on toxicity to male fertilityFDA 4 International Conference on Harmonisation: maintenance of the ICH guidelineon toxicity to male fertility; An addendum to the ICH tripartite guideline ondetection of toxicity to reproduction for medicinal products, amended November9, 2000Indirect Food AdditivesFDA, Bureau ofFoodsFDA, Center for FoodSafety and AppliedNutritionFDA, Center for FoodSafety and AppliedNutrition20 Toxicological principles and procedures for priority based assessment of foodadditives (Red Book), guidelines for reproduction testing with a teratology phase6 Toxicological principles for the safety assessment of direct food additives andcolor additives used in food (Red Book II), guidelines for reproduction anddevelopmental toxicity studies21 Toxicological principles for the safety of food ingredients (Red Book 2000)ChemicalsEPA, OPPTS 22 Health effects test guidelines: prenatal developmental toxicity studyEPA, OPPTS 23 Health effects test guidelines: reproduction and fertility effectsEPA, OPPTS 24 Health effects test guidelines: developmental neurotoxicity studyEPA, Risk25 Guidelines for developmental toxicity risk assessmentAssessment ForumEPA 26 Guidelines for developmental toxicity risk assessmentOECD 27 Guidelines for testing of chemicals: teratogenicityOECD 28 Guidelines for testing of chemicals: one-generation reproduction toxicityOECD 29 Guidelines for testing of chemicals: two-generation reproduction toxicity studyOECD 30 Guidelines for testing of chemicals: combined repeated dose toxicity study withthe reproduction and developmental toxicity screening testOECD 31 Guidelines for testing of chemicals: developmental neurotoxicity studyTable 19.2 List of useful websites for obtaining regulatory documentsFederal Registerhttp://www.access.gpo.gov/su_docs/aces/aces140.htmlFDA guidance documentshttp://www.fda.gov/cder/guidance/index.htmICH guidelineshttp://www.ifpma.org/ich5s.htmlRed Book 2000http://vm.cfsan.fda.gov/~redbook/red-toct.htmlEPA (public drafts)http://www.epa.gov/OPPTS_Harmonized/870_Health_Effects_Test_Guidelines/DraftsEPA (final guidelines)http://www.epa.gov/docs/OPPTS_Harmonized/870_Health_Effects_Test_Guidelines/Series/EPA guidelines for reproductive toxicity http://www.epa.gov/ordntrnt/ORD/WebPubs/repro/index.htmlrisk assessmentEPA’s EDSTAChttp://www.epa.gov/scipoly/oscpendo/index.htmEPA Food Quality Protection Act of 1996 http://www.epa.gov/opppsps1/fqpaOECD guidelineshttp://www.oecd.org/ehs/test/testlist.htmOECD endocrine disrupter testing andassessmenthttp://www.oecd.org/EN/document/0,,EN-document-524-14-no-24-6685-0,00.htmlU.S. National Toxicology Program (NTP) http://ntp-server.niehs.nih.gov/main_pages/NTP_ALL_STDY_PG.htmltesting information and study resultsCalifornia Proposition 65 documents http://www.oehha.org/prop65.html© 2006 by Taylor & Francis Group, LLC