Registration Dossier
Registration Dossier
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EC number: 430-820-8 | CAS number: 114341-88-7
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, B7
- GLP compliance:
- yes
- Limit test:
- no
Test animals
- Species:
- other: Rat - Alpk: APfSD
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
- 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 50 mg/kg bw/day
Male: 5 animals at 150 mg/kg bw/day
Female: 5 animals at 15 mg/kg bw/day
Female: 5 animals at 50 mg/kg bw/day
Female: 5 animals at 150 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
150mg/kg/day: Salivation (males and females) and urine
staining and ungroomed coat (males). Slightly increased
hindlimb grip strength (males).
Laboratory findings:
150mg/kg/day: Increased white blood cell and neutrophil
counts.
Effects in organs:
150mg/kg/day: Slightly increased liver weights (females).
Red discolouration of the mesenteric lymph nodes (males) and
multiple pale areas on the gastric serosa of one male. An
abdominal cavity mass adjacent to the stomach of one female
and red discolouration of the salivery gland of another
female. Histopathological changes in the stomachs of 3/5
males (moderate acanthosis and hyperkeratosis of the
non-glandular epithelium accompanied by inflammation
involving all layers of the stomach wall; ulceration of both
the glandular and non-glandular epithelium; moderate
submucosal inflammation). Moderate sinus erythrocytosis of
the mesenteric lymph nodes of 3/5 males.
50mg/kg/day: Slightly increased liver weights (females).
15mg/kg/day: Slightly increased liver weights (females).
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 50 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- < 15 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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