Title: Estimation of Acute Oral Toxicity Using the No Observed Adverse Effect Level (NOAEL) from the 28 Day Repeated Dose Toxicity Studies in Rats
Authors: BULGHERONI ANNAKINSNER-OVASKAINEN AGNIESZKAHOFFMANN SEBASTIANHARTUNG THOMASPRIETO PERAITA MARIA DEL PILAR
Citation: REGULATORY TOXICOLOGY AND PHARMACOLOGY vol. 53 no. 1 p. 16-19
Publisher: ACADEMIC PRESS INC ELSEVIER SCIENCE
Publication Year: 2009
JRC N°: JRC45632
ISSN: 0273-2300
URI: http://www.elsevier.com/locate/yrtph
http://publications.jrc.ec.europa.eu/repository/handle/JRC45632
DOI: 10.1016/j.yrtph.2008.10.001
Type: Articles in Journals
Abstract: Acute systemic toxicity is one of the areas of particular concern due to the 2009 deadline set by the 7th Amendment of the Cosmetics Directive (76/768/EEC), which introduces a testing and marketing ban of cosmetic products with ingredients tested on animals. The scientific community is putting considerable effort into developing and validating non-animal alternatives in this area. However, it is unlikely that validated and regulatory accepted alternative methods and/or strategies will be available in March 2009. Following the initiatives undertaken in the pharmaceutical industry to waive the acute oral toxicity testing before going to clinical studies by using information from other in vivo studies, we proposed an approach to identify non-toxic compounds (LD50 > 2000 mg/kg) using information from 28 days repeated dose toxicity studies. Taking into account the high prevalence of non-toxic substances (87%) in the New Chemicals Database, it was possible to set a NOAEL threshold of P200 mg/kg that allowed the correct identification of 63% of non-toxic compounds, while <1% of harmful compounds were misclassified as non-toxic. Since repeated dose toxicity studies can be performed in vivo until 2013, the proposed approach could have an immediate impact for the testing of cosmetic ingredients.
JRC Institute:Institute for Health and Consumer Protection

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