Registration Dossier

Administrative data

Key value for chemical safety assessment

Additional information

Justification for selection of genetic toxicity endpoint
Well documented study by a reputable U.S. Government laboratory following a protocol equivalent/similar to OECD guidelines.

Short description of key information:
Allantoin was found to be non-mutagenic in the Ames Assay in the S. typhimurium TA1535, TA1538, TA98, TA100 bacterial strains.

In addition, male and female rats were fed 0.2% Allantoin in feed over a period of 2 years [approximate total doses of Allantoin throughout the whole exposure were 40 g/rat (male) and 28 g/rat (female)]. After 2 years, carcinogenic effects of the test animals were compared to those of control animals. Allantoin did not induce a significant increase in tumor incidences in the test animals and is therefore considered to be non-carcinogenic.

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

Based on the available data, Allantoin is not a mutagen and is not classified for mutagenicity according to EU Directive 67/548/EEC and Regulation 1272/2008.