Registration Dossier
Registration Dossier
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EC number: 401-300-8 | CAS number: 86168-95-8
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Body responsible for the test
Data source
Reference
- Reference Type:
- other: Body responsible for the test
- Title:
- Unnamed
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Version / remarks:
- (12.05.81)
- Deviations:
- not specified
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Version / remarks:
- (25.04.1984)
- Deviations:
- not specified
- GLP compliance:
- not specified
- Limit test:
- no
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
Constituent 1
Test animals
- Species:
- other: rat, Tif:RAIf (SPF)
- Strain:
- other: F3-hybrid of RII 1/Tif x RII 2/Tif
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Distilled water containing 0.5% CMC and 0.1% Tween80
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- 1 dose per day, 7 times per week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 40, 200 and 1000 mg/kg bw
Basis:
no data
- No. of animals per sex per dose:
- 5
- Control animals:
- not specified
Results and discussion
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 200 other: mg/kg bw/day
- Based on:
- not specified
- Sex:
- male/female
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Signs of toxicity related to dose levels, and including haemathology and clinical chemistry findings:
- No clinical symptoms and no signs of systemic toxicity were observed during the treatment. - Haematology: A minor increase in the % of segmented neutrophils was found in m and f of the 1000 mg/kg bw dosage group but without statistical significance. - Blood chemistry: Only a minor increase in aspartate aminotransferase activity (statistically not significant ) was observed in the m group 4, treated with 1000 mg/kg bw. Effects on organs: - (gros and microscopic) related to dose level: Neither macroscopical nor microscopical findings revealed evidence of a reaction to the treatment.Applicant's summary and conclusion
- Conclusions:
- NOAEL = 200 mg/kg bw/day (in rats of both sexes)
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