Registration Dossier
Registration Dossier
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EC number: 206-019-2 | CAS number: 288-32-4
Neurotoxicity
Administrative data
- Endpoint:
- neurotoxicity
- Adequacy of study:
- supporting study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
Materials and methods
- Principles of method if other than guideline:
- other: OECD 408
- GLP compliance:
- yes
Test material
- Reference substance name:
- Imidazole
- EC Number:
- 206-019-2
- EC Name:
- Imidazole
- Cas Number:
- 288-32-4
- Molecular formula:
- C3H4N2
- IUPAC Name:
- 1H-imidazole
- Details on test material:
- Imidazole (CAS: 288-32-4), purity 99.8%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- other: gavage
- Vehicle:
- water
- Duration of treatment / exposure:
- Exposure period: 90 day(s)
- Frequency of treatment:
- 7/wk
Doses / concentrations
- Remarks:
- Doses / Concentrations:
0, 20, 60, 180 mg/kg bw/d
Basis:
- No. of animals per sex per dose:
- 100
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- Type: other: 90 d-study
Observation period: none
Results and discussion
Any other information on results incl. tables
Result: negative
No behavioral changes were noted at any of the dose levels including 180 mg/kg bw/d during the numerous tests performed
in the functional observation battery, FOB, and the motor activity.
Applicant's summary and conclusion
- Executive summary:
A 90 day oral study in Wistar rats treated ad dose levels from 20 to 180 mg/kg bw/day found no treatment related alterations in behavioural tests (Functional Observational Battery, FOB) or motor activity assessments. The gavage dose levels were 0 (vehicle control, water), 20, 60 or 180 mg/kg bw/day. In addition, the brain, spinal cord and peripheral nervous system were examined by histopathology (control group and top dose group), but no treatment-related findings were noted. The no observable effect level (NOAEL) was 180 mg/kg bw/d for these endpoints in this study.
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