Registration Dossier
Registration Dossier
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EC number: 454-190-9 | CAS number: 324763-51-1
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: 96/54/EC, EC Method B.7. OECD Guideline No. 407
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: Rat, F344 Fischer.
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: An aqueous solution of the test substance was used.
- Details on oral exposure:
- Method of administration:
Stomach intubation. - 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 100 mg/kg bw/day
Male: 5 animals at 316 mg/kg bw/day
Male: 5 animals at 1000 mg/kg bw/day
Female: 5 animals at 100 mg/kg bw/day
Female: 5 animals at 316 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: none in any group.
Body weight gain: Lower in the high dosed group males in the
first 2 weeks (compared to controls); otherwise
inconspicuous body weight development.
Feed consumption: Slightly less in the high dosed groups 4m
and 4f. Slightly more in high dosed recovery group 6f.
Clinical and functional observations: no relevant findings,
except for a reduced well-being ( shortly after dosing the
high dosed animals.
Laboratory findings:
Haematology: Higher platelet counts in the high dosed males;
lower lymphocyte counts in the high dosed females at the
end of the recovery period.
Blood chemistry: decreased alkaline phosphatase in the high
dosed males but increased alkaline phosphatase in the high
dosed females at the end of the recovery period.
Effects in organs:
Necropsy: no relevant findings.
Organ weights: no relevant findings.
Histopathology: no relevant findings.
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:
- 316 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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