US EPA

3449546 

Technical Report 

Guidance document supporting OECD test guideline 443 on the extended one generation reproductive toxicity test 

Organisation for Economic Co-operation and Development :: OECD 

2013 

OECD Environment, Health and Safety Publications 

Paris, France 

No. 151 / ENV/JM/MONO(2013)10 

68 

English 

http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/JM/MONO%282013%2910&doclanguage=en
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has other version or edition 2919060 Draft guidance document in support of OECD Test Guideline 443 on an extended one generation Reproductive Toxicity Study

This Guidance Document (GD) provides guidance on the design, conduction and interpretation of results of the OECD Test Guideline (TG) 443 for an Extended One Generation Reproductive Toxicity Study. This test for reproductive endpoints covers the interaction of males with females, pregnant females, females with offspring and the development of the F1 offspring to full maturity, at approximately 14 weeks of age.

The project for developing a Guidance Document supporting TG 443 was proposed by the Secretariat and included in the workplan in 2010. The document was then developed by two consultants in close cooperation with the expert group on reproductive toxicity and the Secretariat and was sent three times to the WNT for comments between September 2011 and October 2012.

Together with the GD 117 on the Current Implementation of Internal Triggers in Test Guideline 443 for an Extended One Generation Reproductive Toxicity Study, in the United States and Canada, they constitute a set of two TG 443 specific Guidance Documents. Other GDs, also published under the Series on Testing and Assessment (i.e. GD 43, GD106, GD150), provide support to reproductive toxicity studies. They are therefore also highly relevant for TG 443 and can be consulted in addition to this current document since relevant aspects are cross-referenced where applicable.

This Guidance Document was approved by the WNT at its meeting in April 2013. The Joint Meeting of the Chemicals Committee and the Working Party on Chemicals, Pesticides and Biotechnology agreed to its declassification on 14 June, 2013.

This document is published under the responsibility of the Joint Meeting of the Chemicals committee and the Working Party on Chemicals, Pesticides and Biotechnology. 

Series on Testing and Assessment