Registration Dossier

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

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.

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.