Registration Dossier

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:
1999
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

Constituent 1
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

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.