Guia oecd – carcinogenicidade (oecd 451)

OECD/OCDE

Adopted: 7 September 2009

451

OECD GUIDELINE FOR THE TESTING OF CHEMICALS
Carcinogenicity Studies

INTRODUCTION 1. OECD Guidelines for the Testing of Chemicals (TGs) are periodically reviewed in the light of scientific progress, changing assessment practices and animal welfare considerations. The original Test Guideline 451 on Carcinogenicity Studies was adopted in 1981. Development of a revised TG 451 was considered necessary, in order to reflect recent developments in the field of animal welfare and regulatory requirements (1) (2) (3) (4) (5). The updating of TG 451 has been carried out in parallel with revisions of the Test Guidelines 452, Chronic Toxicity Studies, and 453, Combined Chronic Toxicity\Carcinogenicity Studies, and with the objective of obtaining additional information from the animals used in the study and providing further detail on dose selection. This Test Guideline is designed to be used in the testing of a broad range of chemicals, including pesticides and industrial chemicals. It should be noted however that some details and requirements may differ for pharmaceuticals (see International Conference on Harmonisation (ICH) Guidance S1B on Testing for Carcinogenicity of Pharmaceuticals). 2. The majority of carcinogenicity studies are carried out in rodent species, and this Test Guideline is intended therefore to apply primarily to studies carried out in these species. Should such studies be required in non-rodent species, the principles and procedures outlined in this Guideline together with those outlined in OECD TG 409, Repeated Dose 90-day Oral Toxicity Study in Non-Rodents (6) should be applied, with appropriate modifications. Further guidance is available in the OECD Guidance Document No. 116 on the Design and Conduct of Chronic Toxicity and Carcinogenicity Studies (7). 3. The three main routes of administration used in carcinogenicity studies are oral, dermal and inhalation. The choice of the route of administration