Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 202-777-3 | CAS number: 99-66-1
Acute Toxicity: oral
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:
- 1 990
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 substance name:
- Valproic acid
- IUPAC Name:
- Valproic acid
- 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.
Constituent 1
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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
