Registration Dossier
Registration Dossier
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EC number: 207-313-3 | CAS number: 461-72-3
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- documentation insufficient for assessment
- Remarks:
- Report in Japanese language
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Hydantoin
- EC Number:
- 207-313-3
- EC Name:
- Hydantoin
- Cas Number:
- 461-72-3
- Molecular formula:
- C3H4N2O2
- IUPAC Name:
- hydantoin
- Test material form:
- not specified
Constituent 1
- Specific details on test material used for the study:
- purity not less than 99%
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- methylcellulose
- Remarks:
- 0.5% aqueous solution
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Dose / conc.:
- 0 mg/kg bw/day (nominal)
- Remarks:
- recovery group
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- Remarks:
- recovery group
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- 28 days of treatment period, 14 days recovery time
- Positive control:
- no
Examinations
- Sacrifice and pathology:
- Plan killing: days 29, 43
Results and discussion
Results of examinations
- Clinical biochemistry findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Increased activation thromboplastin time (APTT) in mg /kg/day group, high albumin (Alb), total cholesterol (T-Cho) in female 1000 mg/kg/day group in blood biochemical test.
- Urinalysis findings:
- effects observed, treatment-related
- Description (incidence and severity):
- Lower value of electrolyte concentration in male and female 1000 mg/kg/day group in urinalysis.
- Organ weight findings including organ / body weight ratios:
- effects observed, non-treatment-related
- Description (incidence and severity):
- A high value of the liver relative weight of the male 1000 mg/kg/day group at the time of administration was confirmed.
Effect levels
- Dose descriptor:
- NOEL
- Effect level:
- 300 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- clinical biochemistry
- urinalysis
- Remarks on result:
- other: recovery was recognized for these changes
Applicant's summary and conclusion
- Conclusions:
- NOEL is judged to be 300 mg/kg/day for both males and females.
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