The holy grail in genetic toxicology: Follow-up approaches for positive results in the Ames assay-Reference-Cited by-同舟云学术

The holy grail in genetic toxicology: Follow-up approaches for positive results in the Ames assay

Published:2013-09-16 Issue:8 Volume:54 Page:617-620
ISSN:0893-6692
Container-title:Environmental and Molecular Mutagenesis
language:en
Short-container-title:Environ. Mol. Mutagen.

Author:

Aardema Marilyn J.¹

Affiliation:

1. Marilyn Aardema Consulting; Fairfield Ohio

Publisher

Wiley

Subject

Health, Toxicology and Mutagenesis,Genetics (clinical),Epidemiology

Reference9 articles.

1. Follow-up actions from positive results of in vitro genetic toxicity testing;Dearfield;Environ Mol Mutagen,2011

2. ECHA 2012 Guidance on information requirements and chemical safety assessment, Chapter R.7a: Endpoint specific guidance Reference http://echa.europa.eu/web/guest/guidance-documents/guidance-on-reach

3. ECHA 2013 Technical discussion session on the scientific adequacy of in vivo mutagenicity assays, the transgenic rodent gene mutation assay and the unscheduled DNA synthesis assay ECHA-13-R-01-EN

4. EU 2003 EC-Directive 2003/15/EC of the European Parliament and of the Council 26 2003

5. ICH M7 2013 Draft Guidelines, Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals to Limit Potential Carcinogenic Risk http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Multidisciplinary/M7/M7_Step_2.pdf

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