Registration Dossier
Registration Dossier
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EC number: 202-777-3 | CAS number: 99-66-1
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- July 1998
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study without detailed documentation
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 999
- Report date:
- 1999
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
- Deviations:
- yes
- GLP compliance:
- yes
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.: batch 8M00005
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- other: New Zealand hybrid, SPF
Test system
- Type of coverage:
- semiocclusive
- Preparation of test site:
- not specified
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: the contralateral zone serving as control
- Amount / concentration applied:
- 500 mg/animal
- Duration of treatment / exposure:
- 4 hours
- Observation period:
- 1h, 24h, 48h, and 72h afte bandage removal
- Number of animals:
- 3 males per group
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- animal #1
- Time point:
- other: mean scores 24-48-72h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- erythema score
- Basis:
- animal #2
- Time point:
- other: mean scores 24-48-72h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 8 days
- Irritation parameter:
- erythema score
- Basis:
- animal #3
- Time point:
- other: mean scores 24-48-72h
- Score:
- 1.67
- Max. score:
- 4
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- edema score
- Basis:
- animal #1
- Time point:
- other: mean scores 24-48-72h
- Score:
- 0.33
- Max. score:
- 4
- Reversibility:
- fully reversible within: 6 days
- Irritation parameter:
- edema score
- Basis:
- animal #2
- Time point:
- other: mean scores 24-48-72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
- Irritation parameter:
- edema score
- Basis:
- animal #3
- Time point:
- other: mean scores 24-78-72h
- Score:
- 0
- Max. score:
- 4
- Reversibility:
- fully reversible
Applicant's summary and conclusion
- Interpretation of results:
- other: Classified Skin irrit 2 (H315)
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The degre of the lesion observed and the duration of the reversibility study led us to classify the compound Skin irrit 2 (H315).
According to the CLP regulation, the test substance is not classified regarding skin irritation, because the mean value for erythema or for oedema scores in at least 2 of 3 tested animals was <2.3, and the effects have disappeared at the end of the reversibility period.
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