NDLI: Combined retrospective analysis of 498 rat multi-generation reproductive toxicity studies: on the impact of parameters related to F1 mating and F2 offspring.

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Combined retrospective analysis of 498 rat multi-generation reproductive toxicity studies: on the impact of parameters related to F1 mating and F2 offspring.

Content Provider	World Health Organization (WHO)-Global Index Medicus
Author	Piersma, A. H. Rorije, E. Beekhuijzen, M. E. W. Cooper, R. Dix, D. J. Heinrich-Hirsch, B. Martin, M. T. Mendez, E. Muller, A. Paparella, M. Ramsingh, D. Reaves, E. Ridgway, P. Schenk, E. Stachiw, L. Ulbrich, B. Hakkert, B. C.
Description	Country affiliation: Netherlands Author Affiliation: Piersma AH ( Laboratory for Health Protection Research, National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands. aldert.piersma@rivm.nl)
Abstract	The multi-generation reproductive toxicity study (OECD TG 416 and USEPA 870.3800) has been extensively used internationally to assess the adverse effects of substances on reproduction. Recently the necessity of producing a second generation to assess the potential for human health risks has been questioned. The present standardized retrospective analysis of the impact of the second generation on overall study outcome combines earlier analyses and includes 498 rat multi-generation studies representing 438 different tested substances. Detailed assessment of study reports revealed no critical differences in sensitivities between the generations on the basis of a consideration of all endpoints evaluated. This analysis indicates that the second generation mating and offspring will very rarely provide critical information. These findings are consistent with the conclusions of previous retrospective analyses conducted by RIVM, USEPA and PMRA and support adoption of the proposed OECD extended one-generation reproductive toxicity study protocol in regulatory risk assessment testing strategies.
File Format	HTM / HTML
ISSN	08906238
Issue Number	4
Volume Number	31
e-ISSN	18731708
Journal	Reproductive Toxicology
Language	English
Publisher	Elsevier
Publisher Date	2011-05-01
Publisher Place	United States
Access Restriction	One Nation One Subscription (ONOS)
Subject Keyword	Discipline Embryology Discipline Reproductive Medicine Discipline Toxicology Reproductive Physiological Phenomena Drug Effects Research Design Toxicity Tests Aging Animals Dose-response Relationship, Drug Embryonic Development Endpoint Determination Female Fertility Gestational Age Lactation Litter Size Male Maternal Exposure Paternal Exposure Pregnancy Prenatal Exposure Delayed Effects Rats Reproduction Standards Risk Assessment Journal Article Research Support, Non-u.s. Gov't
Content Type	Text
Resource Type	Article
Subject	Toxicology

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Combined retrospective analysis of 498 rat multi-generation reproductive toxicity studies: on the impact of parameters related to F1 mating and F2 offspring.