Registration Dossier
Registration Dossier
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EC number: 478-270-8 | CAS number: 944716-73-8
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Adequacy of study:
- other information
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: Annex V
- GLP compliance:
- yes
- Limit test:
- yes
Test animals
- Species:
- other: Rat (Sprague Dawley)
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- water
- Details on oral exposure:
- Method of administration:
Gavage - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 15 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 1000 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
There were no unscheduled deaths, nor any treatment related
effects on the following parameters: sensory reactivity,
grip strength, motor activity, food consumption, the
clinical laboratory investigations and the macroscopic and
microscopic examination.
Laboratory findings:
The principal effect of treatment was the bright yellow
urine and staining of the bedding material. Higher than
control bodyweight gain was noted for both sexes treated at
1000 mg/kg/day and for males treated at 150 mg/kg/day.
Effects in organs:
Liver weights were also slightly higher than control (after
adjustment for bodyweight) for females treated at 150 or
1000 mg/kg/day.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 15 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
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