Guidance Document on Mammalian Reproductive Toxicity Testing and Assessment / OECD.

Format:

Book

Author/Creator:

Organisation for Economic Co-operation and Development, author, issuing body.

Series:

OECD environmental health and safety publications. Series on testing and assessment.

OECD Series on Testing and Assessment

Language:

English

Subjects (All):

Reproductive toxicology.

Physical Description:

1 online resource (88 pages).

Place of Publication:

Paris : OECD Publishing, 2008.

Summary:

This document is intended to provide guidance on methodological aspects, interpretation of data and an overall approach for testing of chemicals for potential human and other mammalian reproductive toxicity. The document constitutes an essential supplement to existing OECD Test Guidelines that can be used to obtain information on the potential reproductive toxicity of chemicals. Specific OECD Test Guidelines include the one- and two-generation toxicity study (TG 415 and 416), prenatal developmental toxicity study (TG 414), developmental neurotoxicity study (TG 426) and the reproduction/developmental toxicity screening tests (TG 421 and 422). However, data from other toxicity studies e.g., repeated dose toxicity studies for systemic toxicity (TG 407, 408 and 409) may indicate potential reproductive toxicity and should be considered in the assessment as well as existing human data.

Contents:

I. Introduction

History of the document

Purpose of the document

Definition of developmental/reproductive toxicity and principles of reproductive toxicity hazard assessment

Identification and assessment of the effects of chemicals on reproduction and development

Reproductive Toxicity Tests

Assessment of Systemic Effects in Adult Animals

Significance of Experimental Data and their Relevance to Humans (Extrapolation)

Single and Multi-Generation Studies

Prenatal Developmental Toxicity Study, Teratology Study

Developmental Neurotoxicity Studies

Reproduction/Developmental Toxicity Screening Tests

Other In Vivo Toxicity Tests

II. Prenatal End Points

Overview of endpoints assessed

Laboratory Animal Studies

Critical Windows of Exposure

Latent Effects

Methodological issues

Corpora Lutea

Pre- and Post-Implantation Loss

External Foetal and Neonatal Examinations

Visceral Foetal Examinations

Skeletal Examinations

Data interpretation

Malformations versus Variations

International Harmonisation of Terminology

Interrelationship of Endpoints

III. Postnatal endpoints: Neonatal growth, developmental landmarks and functional/behavioural neurotoxicity

Standardisation of Litter Size

Route of Exposure

Cross-Fostering

Age of Pups

Time of Testing

Experiences of Offspring

Sex of Offspring

Experimenters Influence on Results in Behavioural Tests

Test Automation

Groups for Behavioural Assessment

Physical Developmental Landmarks

General Methodological Considerations for Conducting Neurobehavioural Measures

Measures of Behavioural Ontogeny

Measures of Motor Activity

Measures of Motor and Sensory Function

Measures of Learning and Memory

Water mazes

Postmortem evaluation of nervous system tissues in the Developmental Neurotoxicity (DNT) study

Issues in interpretation of neurobehavioral data

Test validity for behavioural endpoints

Neuropathological endpoints

Relationship of Maternal and Offspring End Points

Litter Size, Sex and Mean Pup Body Weight

Physical and Functional Developmental Landmarks

IV. Reproductive Endpoints in adults

Overview of Endpoints Assessed

Methodological Issues

Examination of Male Reproductive Organs

Sperm Parameters

Examination of Female Reproductive Organs

Oocyte Quantitation

Vaginal Cytology

Reproductive Performance

Data Interpretation

Male Reproductive Organs

Female Reproductive Organs

V. Data Gaps

Endpoints

Critical windows of exposure and effect

VI. REFERENCES

Ison, J.R. (1984) Reflex modification as an objective test for sensory processing following toxicant exposure. Neurobehav. Toxicol. Teratol., 6:437-445

Koch, M. (1999) The neurobiology of startle. Prog. Neurobiol. 59:107-128

Appendix I

Appendix 2

Appendix 3.

Notes:

Description based on publisher supplied metadata and other sources.

ISBN:

92-64-65735-5