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EC number: 411-380-6 | CAS number: 147315-50-2 CG 30-1577
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.
Data source
Reference
- Reference Type:
- other: SNIF
- Title:
- Unnamed
- Year:
- 1 993
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- not specified
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.7 (Repeated Dose (28 Days) Toxicity (Oral))
- Deviations:
- not specified
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Body responsible for the test
- IUPAC Name:
- Body responsible for the test
- Test material form:
- not specified
Constituent 1
Test animals
- Species:
- rat
- Strain:
- not specified
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: feed
- Vehicle:
- unchanged (no vehicle)
- Details on oral exposure:
- Method of administration: admixed in food
- Analytical verification of doses or concentrations:
- not specified
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Male: 0, 8.95, 59.1 and 1130 mg/kg bw/day; female: 0, 8.62, 55.5 and 1090 mg/kg bw/day
Basis:
no data
- No. of animals per sex per dose:
- Male: 10 animals at 0 mg/kg bw/day
Male: 5 animals at 8.95 mg/kg bw/day
Male: 5 animals at 59.1 mg/kg bw/day
Male: 10 animals at 1130 mg/kg bw/day
Female: 10 animals at 0 mg/kg bw/day
Female: 5 animals at 8.62 mg/kg bw/day
Female: 5 animals at 55.5 mg/kg bw/day
Female: 10 animals at 1090 mg/kg bw/day - Control animals:
- not specified
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- no effects observed
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- not specified
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- Clinical observations:
There were no clinicals signs nor signs of systemic toxicity.
Laboratory findings:
The treatment had no influence on the hematlogical profile and non on blood chemistry parameters.
Effects in organs:
No treatment related changes were observed.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 1 090 mg/kg bw/day (nominal)
- Based on:
- not specified
- Sex:
- female
- Basis for effect level:
- other: original NCD unit is mg/kg/day
- Dose descriptor:
- NOEL
- Effect level:
- 1 090 mg/kg bw/day (nominal)
- Based on:
- not specified
- Sex:
- female
- Basis for effect level:
- other: original NCD unit is mg/kg/day
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
Doses at which no effect were observed: 1090 mg/kg in females and 1130 mg/kg in males.
Applicant's summary and conclusion
- Conclusions:
- NOAEL = 1090 mg/kg in females;
doses at which no effect were observed: 1090 mg/kg in females and 1130 mg/kg in males - Executive summary:
The oral repeated dose toxicity of the test substance has been determined in a subacute GLP study with rats (3 groups of males and 3 groups of females) according to OECD Guideline 407 and EU Method B.7 (28-days, 7 days a week, of oral exposure (admixed in food) at doses of 0, 8.95, 59.1 and 1130 mg/kg bw/day (male) and 0, 8.62, 55.5 and 1090 mg/kg bw/day (female), respectively). The test substance was on the whole well tolerated up to and including the highest dosage administered because no signs of toxicity were observed. A NOEL and NOAEL of 1090 mg/kg bw/day have been determined.
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