Registration Dossier
Registration Dossier
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EC number: 206-017-1 | CAS number: 288-13-1
Developmental toxicity / teratogenicity
Administrative data
- Endpoint:
- developmental toxicity
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable, well documented publication/ study report which meets basic scientific principles.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 989
- Report date:
- 1989
Materials and methods
- Principles of method if other than guideline:
- according to literature
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- Pyrazole
- EC Number:
- 206-017-1
- EC Name:
- Pyrazole
- Cas Number:
- 288-13-1
- Molecular formula:
- C3H4N2
- IUPAC Name:
- 1H-pyrazole
- Details on test material:
- Purity 98.0%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- corn oil
- Duration of treatment / exposure:
- gestation days 6-15
- Frequency of treatment:
- daily
- Duration of test:
- 20 days
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 1, 5, 10, 15, 20 mg/kg/day
Basis:
- No. of animals per sex per dose:
- 8
- Control animals:
- yes
Results and discussion
Results: maternal animals
Effect levels (maternal animals)
- Dose descriptor:
- NOAEL
- Effect level:
- 1 mg/kg bw/day
- Basis for effect level:
- other: maternal toxicity
Results (fetuses)
Effect levels (fetuses)
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 5 mg/kg bw/day
- Basis for effect level:
- other: fetotoxicity
- Dose descriptor:
- NOAEL
- Effect level:
- 15 mg/kg bw/day
- Basis for effect level:
- other: teratogenicity
Fetal abnormalities
- Abnormalities:
- not specified
Overall developmental toxicity
- Developmental effects observed:
- not specified
Any other information on results incl. tables
Pyrazole caused developmental as well as maternal toxicity in rats at dose levels >= 10 mg/kg/day. No mortality occurred at any dose level. Substantial body weight losses were noted at 15 and 20 mg/kg/day. Slight to moderate mean body weight effects occurred at 10 and possibly 5 mg/kg/day, primarily during the first 3 days of dosing. A dose related decrease in mean fetal weights was apparent at >= 10 mg/kg/day. The only external malformations observed were cleft palate in 6 fetuses from 2 litters at 20 mg/kg/day.
Applicant's summary and conclusion
- Conclusions:
- Regarding the results of the study, the NOAEL for developmental toxicity is 5 mg/kg bw/day. There were no indications for developmental toxicity in doses below maternal toxic doses.
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