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Toxicological information

Skin irritation / corrosion

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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:
1999
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

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.: batch 8M00005

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.