Registration Dossier
Registration Dossier
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EC number: 451-520-3 | 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
- Principles of method if other than guideline:
- EC Directive 96/54/EC, Annex IV.D, replacing EC Directive
67/548/EEC, Part B: Methods for the Determination of
Toxicity and other Health Effects; B.7: "Repeated Dose (28
days) Toxicity (oral)". Official Journal of the European
Communities No. L248, September 1996.
OECD Guideline for Testing of Chemicals, Guideline 407:
"Repeated Dose 28-day Oral Toxicity Study in Rodents", Paris
Cedex, 27 July 1995.
United States Environmental Protection Agency (EPA). Health
Effects Test Guidelines, 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,
July 2000. - GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: Rat, Wistar Crl:(WI) BR
Administration / exposure
- Route of administration:
- oral: unspecified
- Vehicle:
- corn oil
- 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:
50 mg/kg/day:
None
150 mg/kg/day:
Increased absolute and relative food consumption (males).
1000 mg/kg/day:
Diarrhoea (males and females)
Increased absolute and relative food consumption (males)
Laboratory findings:
1000 mg/kg/day:
Increased plasma bilirubin, individual alanine and aspartate
aminotransferase and urea levels (males)
Effects in organs:
1000 mg/kg/day:
Corticomedullary tubular basophilia in the kidneys (3/5
males).
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 150 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 150 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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