Registration Dossier
Registration Dossier
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EC number: 201-051-3 | CAS number: 77-71-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed to GLP and is equivalent to a guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 980
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EPA OPP 81-1 (Acute Oral Toxicity)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- 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
- Details on test material:
- - Name of test material (as cited in study report): 5,5-dimethylhydantoin
- Physical state: Solid (white crystalline powder)
- Storage condition of test material: Room temperature in a locked cabinet
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Industries, Indianapolis. Indiana
- Age at study initiation: Young adult
- Weight at study initiation: Males: 151 - 159 g. Females: 131 - 146 g
- Housing: Individually housed in stainless steel cages
- Diet: ad libitum
- Acclimation period: 8 days
Administration / exposure
- Route of administration:
- oral: gavage
- Doses:
- 5000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed for gross signs of systemic toxicity and mortality at frequent intervals during dosing and twice daily thereafter. All rats were weighed on day 0, 7 and 14.
- Necropsy of survivors performed: yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- 5 000 mg/kg bw
- Mortality:
- No mortalities occurred during the study
- Clinical signs:
- other: On the day of dosing two females were observed to be slightly to moderately lethargic and slight lacrimation was noted which subsided by day 1. The females were observed to be normal throughout the remainder of the study
- Gross pathology:
- No signs of systemic toxicity were observed
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information
- Conclusions:
- The acute oral LD50 DMH was > 5000 mg/kg
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