Registration Dossier
Registration Dossier
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EC number: 201-051-3 | CAS number: 77-71-4
Acute Toxicity: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study predates GLP and test guidelines
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- Test substance applied dermally (occlusive dressing) for 24 hours, dressing removed (site not washed) and rabbits observed for up to 14 days.
- 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
- Reference substance name:
- Dimethylhydantoin
- IUPAC Name:
- Dimethylhydantoin
- Details on test material:
- - Name of test material (as cited in study report): Dantoin DMH
-Physical state: white crystals
-Lot/batch No.: 838668
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Test animals
Source: Marland Breeding Farms, Inc.
Weight at study initiation: 2.0-3.5 kgs
Housing: individual
Diet: ad libitum
Water: ad libitum
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- other: saline
- Details on dermal exposure:
- TEST SITE
- % coverage: 10%
TEST MATERIAL
- Amount applied: Each dose was weighed out and 20-25 mL of normal saline was added to moisten the material. A dose level of 20000 mg/kg was applied. - Duration of exposure:
- 14 days
- Doses:
- 20000 mg/kg
- No. of animals per sex per dose:
- 3/sex/group
- Control animals:
- no
- Details on study design:
- Two females and one male received the substance applied to abraded skin, two males and one female received the substance on intact skin.
Duration of observation period following administration: 14 days
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 20 000 mg/kg bw
- Mortality:
- No mortalities occurred in the study
- Clinical signs:
- other: Fecal staining/soft stool, nasal discharge, ocular discharge, collar removed by animal, piloerection, motor activity increase and aggressive behaviour.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- LD50 was estimated > 20000 mg/kg bw.
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