Registration Dossier
Registration Dossier
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EC number: 432-840-2 | CAS number: 220926-97-6
Repeated dose toxicity: oral
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- Deviations:
- yes
- Remarks:
- On isolated occasions slight deviations occurred resulting in an overall range of 20 to 25°C for room temperature and 36 to 74% relative humidity.
- Principles of method if other than guideline:
- Not applicable
- Limit test:
- yes
Test material
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: CD BR rats (Cri : CD® BR)
- Sex:
- male/female
Administration / exposure
- Route of administration:
- oral: gavage
Results and discussion
Results of examinations
- Details on results:
- CLINICAL CHEMISTRY: mean (± SD) ALT values (mU/mL) were significantly (p<0.01) increased compared to controls in females at 4 weeks: 33 ± 3.4, 47 ± 4.3**, 42 ± 5.7** and 39 ± 4.0** for control, 15, 150 and 1000 mg/kg bw/day groups, respectively.
Urea nitrogen was significantly (p<0.05) increased in females of the 1000 mg/kg bw/day at 4 weeks (14 ± 1.3 and 17 ± 2.2 mg/dL, for control and 1000 mg/kg bw/day groups, respectively).
ORGAN WEIGHT: adjusted mean kidneys weights (g) were significantly (**: p<0.01; *:p<0.05) decreased compared to controls in females at 4 weeks: 1.98, 1.95, 1.92 and 1.77** for control, 15, 150 and 1000 mg/kg bw/day groups, respectively. They were significantly increased after the recovery period: 1.86 and 1.98* for control and 1000 mg/kg bw/day groups, respectively. The mean adjusted kidneys weights were also significantly lower than controls for males only after the recovery period: 3.05 and 2.72** for control and 1000 mg/kg bw/day groups, respectively.
URINALYSIS: the volume of urine was significantly (p<0.05) increased in females administered 1000 mg/kg bw/day at 4 weeks (2.4 ± 1.28 and 3.8 ± 0.89 mL, for control and 1000 mg/kg bw/day groups, respectively).
Effect levels
- Dose descriptor:
- NOAEL
- Effect level:
- 1 000 mg/kg bw/day (actual dose received)
- Sex:
- male/female
- Basis for effect level:
- other: overall effects
Target system / organ toxicity
- Critical effects observed:
- not specified
Any other information on results incl. tables
None
Applicant's summary and conclusion
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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