Registration Dossier
Registration Dossier
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EC number: 229-222-8 | CAS number: 6440-58-0
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- yes
- Remarks:
- Only 3 animals used per test group
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 5,5-dimethylhydantoin
- EC Number:
- 201-051-3
- EC Name:
- 5,5-dimethylhydantoin
- Cas Number:
- 77-71-4
- Molecular formula:
- C5H8N2O2
- IUPAC Name:
- 5,5-dimethylimidazolidine-2,4-dione
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: Saline
- Details on dermal exposure:
- TEST SITE
- % coverage: 10%
REMOVAL OF TEST SUBSTANCE
- Washing (if done): Not washed
- Time after start of exposure: 24 hours
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): ~20-25 ml - Duration of exposure:
- 24 hours
- Doses:
- 20 000 mg/kg
- No. of animals per sex per dose:
- 3/sex/group
- Control animals:
- no
- Details on study design:
- 2 females and 1 male received the substance applied to abraded skin, 2 males and 1 female received the substance on intact skin.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 20 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: In-life signs observed within 24 hours of dosing included motor activity decrease and ataxia. Other signs included fecal staining/soft stool, nasal discharge, ocular discharge, collar removed by animal, piloerection, motor activity increase and aggressive
- Gross pathology:
- No effects specified
Applicant's summary and conclusion
- Interpretation of results:
- relatively harmless
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 Dantoin DMH >20000mg/kg.
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