Registration Dossier
Registration Dossier
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EC number: 464-390-8 | CAS number: -
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- repeated dose toxicity: oral
- Remarks:
- other: NOAEL
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: - EC Directive 96/54/EEC, B.7 Repeated Dose (28 days) Toxicity (oral), 1996.
- Principles of method if other than guideline:
- - EC Directive 96/54/EEC, B.7 Repeated Dose (28 days)
Toxicity (oral), 1996.
- OECD 407, Repeated Dose 28-day Oral Toxicity Study in
Rodents, 1995
- OPPTS 870.3050, Repeated dose 28-day oral toxicity study
in rodents. Office of Prevention, Pesticides and Toxic
Substances (7101), EPA 712-C-00-366, 2000. - GLP compliance:
- yes
- Limit test:
- no
Test material
Constituent 1
Test animals
- Species:
- other: Rat, Wistar Crl:(WI) BR
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- other: Water.
- Details on oral exposure:
- Method of administration:
Gavage - Duration of treatment / exposure:
- Test duration: 28 days
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 50 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 50 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 changes at determination of clinical
appearance, performance of functional observations, body
weight and food consumption measurements, that were
considered to be an effect of treatment.
Laboratory findings:
There were no alterations during clinical laboratory
investigations, that were considered to be an effect of
treatment.
Effects in organs:
There were no changes at macroscopic examination, organ
weight determination and microscopic examination that were
considered to be an effect of treatment.
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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