Registration Dossier

Administrative data

Description of key information

No eye or skin irritation was reported in reliable eye and skin irritation studies on Allantoin.  

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Justification for selection of skin irritation / corrosion endpoint:
Study is a reliable OECD guideline study conducted under GLP.

Justification for selection of eye irritation endpoint:
The study was performed at the Centre International de Toxicologie (C.I.T.) in accordance with the protocol agreed upon by Societe Francaise Hoechst (dated 21 September 1984), published in the Journal Officiel de la Republique Francaise (J.O.R.F., dated 24 October 1984) and the Principles of Good Labor Practice (GLP).

Justification for classification or non-classification

Based on reliable in vivo skin and eye irritation data, Allantoin does not meet the criteria for classification as irritant according to EU Directive 67/548/EEC and Regulation 1272/2008.