Guidance Document 116 on the Conduct and Design of Chronic Toxicity and Carcinogenicity Studies, Supporting Test Guidelines 451, 452 and 453

Second edition

This guidance provides additional information on the conduct of studies performed using Test Guidelines 451, 452 and Test Guideline 453. Its objective is to assist users of the TGs to select the most appropriate methodology to assess the chronic toxicity and carcinogenicity of a test chemical so that particular data requirements can be met while reducing animal usage if possible/appropriate.

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