Registration Dossier

Toxicological information

Skin irritation / corrosion

Currently viewing:

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1988
Report Date:
1988

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Principles of method if other than guideline:
3 white New-Zealand rabbits were treated with 0.5 ml of undiluted test substance. The test item remained under semiocclusion on the skin for 4 hours. Treated animals were inspected for skin effects (erythma, oedema) after removal of patches and after 1, 2, 3 and 7 days. Total observation time was 7 days
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
CAS no.: 108-42-9
purity: 99.5%
molecular weight. 127.6 g/mol
appearance: weak yellow liquid
stability: warranted for the test period

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
clipped
Vehicle:
unchanged (no vehicle)
Controls:
not required
Duration of treatment / exposure:
4 hours
Observation period:
7 days
Number of animals:
3 male rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0.9
Max. score:
4
Reversibility:
fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
mean
Time point:
other: 24, 48, and 72 h
Score:
0.7
Max. score:
4
Reversibility:
fully reversible within: 72 hours

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information
Executive summary:

Method: Three white New-Zealand rabbits were treated with 0.5 ml of undiluted test substance. The test item remained under semiocclusion on the skin for 4 hours. Treated animals were inspected for skin effects (erythma, oedema) after removal of patches and after 1, 2, 3 and 7 days. Total observation time was 7 days

Result: slightly irritating to the skin, but not sufficient for classification