Registration Dossier
Registration Dossier
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EC number: 202-592-8 | CAS number: 97-59-6
Acute Toxicity: dermal
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:
- 2 001
- 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 substance name:
- Allantoin
- EC Number:
- 202-592-8
- EC Name:
- Allantoin
- Cas Number:
- 97-59-6
- Molecular formula:
- C4H6N4O3
- IUPAC Name:
- 1-(2,5-dioxoimidazolidin-4-yl)urea
Constituent 1
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.
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