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Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
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:
publication
Title:
Unnamed
Year:
1990

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
The acute oral toxicity of valproic acid was compared with the toxicity of the anticonvulsant calcium valproate and sodium valproate in mice.
GLP compliance:
not specified
Test type:
acute toxic class method

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Supplied by Parke-Davis Pharmaceutical Research Division
- The percentages of active component (valproic acid) were determined by a gas-chromatographic assay for purposes of dose calculation.

Test animals

Species:
mouse
Strain:
Swiss
Sex:
male/female

Administration / exposure

Route of administration:
oral: gavage
Vehicle:
not specified
Doses:
631, 1590, 2510, 3980, 6310 mg/kg
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Effect levelsopen allclose all
Sex:
male
Dose descriptor:
LD50
Effect level:
2 474 mg/kg bw
Based on:
test mat.
95% CL:
>= 2 027 - <= 3 009
Sex:
female
Dose descriptor:
LD50
Effect level:
1 998 mg/kg bw
Based on:
test mat.
95% CL:
>= 1 695 - <= 2 352
Sex:
male/female
Dose descriptor:
LD0
Effect level:
631 mg/kg bw
Based on:
test mat.

Any other information on results incl. tables

Most deaths occurred within 24h after dosing. The most frequently observed clinical signs consisted of incoordination, prostration, sedation, intermittent head shaking and body weight loss.

Applicant's summary and conclusion

Interpretation of results:
sligthly toxic
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
In the conditions of the study, Valproic acid was found slightly toxic to mice by oral administration with the LD50 for females just below the upper limit for classification (Category 4).