Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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.