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Toxicological information

Genetic toxicity: in vivo

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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:
1999
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

Constituent 1
Reference substance name:
Valproic Acid
IUPAC Name:
Valproic Acid

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.