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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Description of key information

There were no significant differences in survival between the treated groups and their controls. The following table depicts the incidence of tumors in rats given feed supplemented with Allantoin for 106 weeks and in control rats: 

Key value for chemical safety assessment

Carcinogenicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed

Carcinogenicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Carcinogenicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

Based on the weight of evidence, Allantoin does not meet the criteria for classification as a carcinogen according to EU Directive 67/548/EEC and Regulation 1272/2008.

Additional information

Justification for selection of carcinogenicity via oral route endpoint:
The study was not performed according to OECD guidelines, however, the study was conducted by a reputable U.S. Governmental laboratory and published as a peer-reviewed paper in a renowned journal. Therefore it is considered to be sound and rated reliable with restrictions.