Evaluation of the sensitivity and specificity of in vivo erythrocyte micronucleus and transgenic rodent gene mutation tests to detect rodent carcinogens

Author:

Morita Takeshi,Hamada Shuichi,Masumura Kenichi,Wakata Akihiro,Maniwa Jiro,Takasawa Hironao,Yasunaga Katsuaki,Hashizume Tsuneo,Honma Masamitsu

Funder

Health and Labor Sciences Research

Publisher

Elsevier BV

Subject

Health, Toxicology and Mutagenesis,Genetics

Reference169 articles.

1. The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), Guidance on Genotoxicity Testing and Data Interpretation for Pharmaceuticals Intended for Human Use, Step 4 in November 2011. Available at http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Safety/S2_R1/Step4/S2R1_Step4.pdf (accessed 26.09.15).

2. UK Committee on Mutagenicity (COM), Guidance on a strategy for genotoxicity testing of chemical substances,2011

3. European Chemical Agency (ECHA), Guidance on Information Requirements and Chemical Safety Assessment, Chapter R.7a, Version 4.1,2015

4. Scientific opinion on genotoxicity testing strategies applicable to food and feed safety assessment, 3 October 2012;HEuropean Food Safety Authority (EFSA);EFSA Journal,2011

5. Identification and evaluation of potentially genotoxic agricultural and food-related chemicals;Hayashi1;Food Saf.,2013

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