Registration Dossier

Toxicological information

Acute Toxicity: dermal

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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Secondary reference - no information provided on methodology.

Data source

Reference
Reference Type:
review article or handbook
Title:
Committee for Veterinary Medicinal Products, Allantoin, Summary Report
Author:
The European Agency for the Evaluation of Medicinal Products
Year:
2001
Bibliographic source:
The European Agency for the Evaluation of Medicinal Products. EMEA/MRL/804/01-FINAL, October 2001

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No information was provided on the methodology used.
GLP compliance:
not specified
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
not specified
Sex:
not specified

Administration / exposure

Type of coverage:
not specified
Vehicle:
not specified
Details on dermal exposure:
Test substance was applied to normal and abraded skin.
Duration of exposure:
No data
Doses:
5 g/kg bw
No. of animals per sex per dose:
No data
Control animals:
not specified
Details on study design:
No data
Statistics:
No data

Results and discussion

Effect levels
Sex:
not specified
Dose descriptor:
LD50
Effect level:
>= 5 000 mg/kg bw
Based on:
test mat.

Applicant's summary and conclusion

Conclusions:
Upon dermal application of allantoin to the normal and abraded skin, the LD50 in rats is more than or equal to 5 g/kg bw.