Registration Dossier
Registration Dossier
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EC number: 603-330-9 | CAS number: 129332-29-2
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 23 November 2001- 20 December 2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2002
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Qualifier:
- according to guideline
- Guideline:
- other: EEC Directive 96/54/EEC, B.7 Repeated Dose (28 days) Toxicity (oral), 1996
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 00945
- IUPAC Name:
- 00945
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Analytical verification of doses or concentrations:
- yes
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- Once daily for at least 28 days, 7 days a week, approximately the same time each day with a maximum of 4 hours difference between the earliest and latest dose. Animals were dosed up the the day prior to necropsy.
- No. of animals per sex per dose:
- 20 males and 20 females
- Control animals:
- yes
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Mortality:
- no mortality observed
- Body weight and weight changes:
- effects observed, treatment-related
- 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:
- no effects observed
- Haematological findings:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
- Histopathological findings: non-neoplastic:
- not specified
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- The test substance was administered daily for 28 days by oral gavage to SPF-bred Wistar rats. One control group and three treated groups were tested, each consisting of 5 males and 5 females.
Effect levels
open allclose all
- Dose descriptor:
- dose level:
- Effect level:
- 50 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: No treatment-related findings noted
- Dose descriptor:
- dose level:
- Effect level:
- 150 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male
- Basis for effect level:
- other: Slightly reduced body weight
- Dose descriptor:
- dose level:
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: Slightly reduced body weight
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- NOEL > 1000mg/kg bw/day
- Executive summary:
Wistar rats were treated with the test substance for 28 consecutive days by oral gavage at does level up to 1000 mg/kg/day.
A slight reduction of body weight was obtained for high dose animals and for group 3 males in the second half of the treatment period when compared to (historical) controls, but occured without a concurrent reduction of food consumption. Since a clear dose related response was absent, this change was considered to be of doubtful tocicological relevance.
Changes of some clinical biochemistry parameters noted in some group 3 and 4 animals were not accompanied by supportive treatment- related microscopic abnormalities. Also, most values of these groups remained comparable values of other studies. Therefore, these changes were considered to be without toxicological importance.
There were no changes at determination of clinical appearance, performance of functional observations, food consumption measurements, or alterations during haematological investigations, macroscopic examination, organ weight determination and microscopic examination that were considered to be an effect of treatment.
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