Registration Dossier
Registration Dossier
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EC number: 202-777-3 | CAS number: 99-66-1
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1977
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only Summary but Basic data given
Data source
Reference
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Male Long-Evans and Sprague-Dawley rats (5 animais of each strain/group) were given valproic acid orally (gavage) at daily doses of 65, 150, and 350 mg/kg for 5 days. Animals were sacrificed and femoral bone marrow fixed, stained and examined.
- GLP compliance:
- no
- Type of assay:
- chromosome aberration assay
Test material
- Reference substance name:
- Valproic Acid
- IUPAC Name:
- Valproic Acid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Long-Evans rats / Sprague-Dawley rats
- Sex:
- male
Administration / exposure
- Route of administration:
- oral: gavage
- Duration of treatment / exposure:
- 5 days
- Frequency of treatment:
- daily
Doses / concentrations
- Remarks:
- Doses / Concentrations:
65; 150 and 350 mg/kg/day
Basis:
actual ingested
- No. of animals per sex per dose:
- Number of animals per dose: 5
- Control animals:
- yes, concurrent vehicle
Examinations
- Tissues and cell types examined:
- Femoral Bone Marrow
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
Any other information on results incl. tables
The only changes observed were chromatid gaps, seen in both controls and valproic acid-treated groups.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
In the conditions of the chromosome aberration assay with rat bone marrow cells, Valproic acid was found not to be toxic or mutagenic.
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