Estimation of acute oral toxicity using the No Observed Adverse Effect Level (NOAEL) from the 28 day repeated dose toxicity studies in rats

Anna Bulgheroni, Agnieszka Kinsner-Ovaskainen, Sebastian Hoffmann, Thomas Hartung, Pilar Prieto

Research output: Contribution to journalArticle

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 ≥200 mg/kg that allowed the correct identification of 63% of non-toxic compounds, while

Original languageEnglish (US)
Pages (from-to)16-19
Number of pages4
JournalRegulatory Toxicology and Pharmacology
Volume53
Issue number1
DOIs
StatePublished - Feb 2009
Externally publishedYes

Fingerprint

No-Observed-Adverse-Effect Level
Cosmetics
Toxicity
Rats
Chemical Databases
Lethal Dose 50
Drug Industry
European Union
Marketing
Testing
Animals
Pharmaceutical Preparations
Industry
Clinical Studies

Keywords

  • 3Rs
  • Acute oral toxicity
  • GHS category
  • NOAEL

ASJC Scopus subject areas

  • Toxicology

Cite this

Estimation of acute oral toxicity using the No Observed Adverse Effect Level (NOAEL) from the 28 day repeated dose toxicity studies in rats. / Bulgheroni, Anna; Kinsner-Ovaskainen, Agnieszka; Hoffmann, Sebastian; Hartung, Thomas; Prieto, Pilar.

In: Regulatory Toxicology and Pharmacology, Vol. 53, No. 1, 02.2009, p. 16-19.

Research output: Contribution to journalArticle

Bulgheroni, Anna ; Kinsner-Ovaskainen, Agnieszka ; Hoffmann, Sebastian ; Hartung, Thomas ; Prieto, Pilar. / Estimation of acute oral toxicity using the No Observed Adverse Effect Level (NOAEL) from the 28 day repeated dose toxicity studies in rats. In: Regulatory Toxicology and Pharmacology. 2009 ; Vol. 53, No. 1. pp. 16-19.
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