Registration Dossier
Registration Dossier
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EC number: 202-777-3 | CAS number: 99-66-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- July 1998
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: in vitro studies with very few details
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- In vitro ocular tests (Ocular irritection, Het Cam, Predisafe) were performed.
- GLP compliance:
- no
Test material
- Reference substance name:
- Valproic Acid
- IUPAC Name:
- Valproic Acid
- Details on test material:
- - Name of test material (as cited in study report): S2404
- Lot/batch No.: 8M00005
Constituent 1
Test system
- Observation period (in vivo):
- 72h (on Day 4)
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- other: index of ocular irritection
- Value:
- 44.4
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- other: IC50 (%) [Predisafe test]
- Value:
- < 50
- Remarks on result:
- positive indication of irritation
- Irritation parameter:
- other: Luëpke score [Het Cam]
- Value:
- 18.5
- Remarks on result:
- positive indication of irritation
Any other information on results incl. tables
In vitro ocular tests: Irritant in vitro
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- An in vitro ocular study was performed: Valproic acid was irritant in vitro. This result confirms the irritant properties of the compound which must be classified Eye Dam 1 (H318), risk of severe ocular lesion.
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