Registration Dossier

Administrative data

Description of key information

In a reliable acute oral toxicity study, no mortality was recorded during the duration of the study.  The LD50 was determined to be >5,000 mg/kg bw.  No symptoms were noted during the observation period and no significant, treatment-related body weight changes were observed during the duration of the study.  No abnormalities were detected upon gross examination of the principal organs of animals euthanized at the end of study.  
In a study reported in the European Agency for the Evaluation of Medicinal Products summary report on Allantoin, the dermal LD50 in rats is more than or equal to 5,000 mg/kg bw.
No data are available via the inhalation route of exposure.

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
5 000 mg/kg bw

Additional information

Justification for selection of acute toxicity – oral endpoint
The available study is a reliable (K1), and well documented study.

Justification for selection of acute toxicity – dermal endpoint
Data were considered adequate on the basis of the assessment made by the European Agency for the Evaluation of Medicinal Products' Committee for Veterinary Medicinal Products, Allantoin, Summary Report.

Justification for classification or non-classification

Based on the available data for the oral and dermal routes, Allantoin is not classified for acute toxicity according to EU Directive 67/548/EEC and Regulation 1272/2008. No data are available for the inhalation route.