Registration Dossier
Registration Dossier
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EC number: 473-870-6 | CAS number: -
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: Commission Directive 96/54/EC, Method B7.
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: Rat, Sprague-Dawley.
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Polyethylene glycol 400.
- 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 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 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:
Mortality Data:
There were no unscheduled deaths during the study.
Clinical Observations:
No clinically observable signs of toxicity were detected in
test or control animals throughout the study period.
Behavioural Assessment:
There were no treatment-related changes in the behavioural
parameters measured.
Functional Performance Tests:
There were no treatment-related changes in the functional
performance parameters measured.
Sensory Reactivity Assessments:
There were no treatment-related changes in sensory
reactivity.
Bodyweight:
No adverse effect on bodyweight development was detected.
Food Consumption:
No adverse effect on dietary intake or food efficiency was
detected.
Water Consumption:
No intergroup differences were detected.
Laboratory findings:
Haematology:
No toxicologically significant changes were detected.
Blood Chemistry:
No toxicologically significant changes were detected.
Effects in organs:
Necropsy:
No treatment-related macroscopic abnormalities were
detected.
Organ Weights:
No toxicologically significant effects were detected.
Histopathology:
No treatment-related microscopic changes were detected.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 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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