Registration Dossier

Administrative data

Description of key information

Annex XI to the REACH Regulation provides for the waiver of additional animal testing in scenarios where adequate data exist, and further animal testing is not scientifically necessary to further the safety argument for the test substance.  Given the preponderance of evidence, as well as the availability of a 2-year tumorigenicity study, it is scientifically unnecessary to generate additional mammalian data for Allantoin.

Key value for chemical safety assessment

Repeated dose toxicity: via oral route - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: inhalation - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - systemic effects

Endpoint conclusion
Endpoint conclusion:
no study available

Repeated dose toxicity: dermal - local effects

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

- Allantoin is the end product of purine metabolism in most mammals, excluding humans and some non-human primates;

- Humans lack the enzyme necessary to convert uric acid to Allantoin, where most test species have this enzyme;

- Allantoin is endogenous in standard test species and thus chronic exposure is not of relevance;

- Allantoin is endogenous in humans as well;

- Normal endogenous levels of Allantoin in humans and standard test species are highly variable;

- QSAR using the OECD Toolbox Category Approach demonstrates a lack of repeated-dose toxicity for Allantoin;

- Hazard classification of Allantoin on the basis of chronic exposure is not warranted;

- Occupational exposure to Allantoin is not anticipated;

- Consumer exposure to Allantoin is limited to cosmetic and pharmaceutical use and is regulated accordingly.

Thus, the relevance of in vivo studies in non-humans is limited and further mammalian testing with Allantoin is scientifically unnecessary.

Justification for classification or non-classification

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