Registration Dossier

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
Reliability:
4 (not assignable)
Rationale for reliability incl. deficiencies:
other: Body responsible for the test

Data source

Reference
Reference Type:
other: Body responsible for the test
Title:
Unnamed

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: OECD GUIDELINE 404 (1981) EEC Directive 84/449 (1984) - Annex V - method B4 EPA n° 798.4470 (1990) MAFF n° 4200 (1985)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
not specified

Test animals

Species:
rabbit
Strain:
other: New Zealand hydbrid albino rabbit

Test system

Type of coverage:
semiocclusive
Vehicle:
other: Sterile Codex liquid paraffin
Duration of treatment / exposure:
4 h
Number of animals:
6

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Score:
0.3
Max. score:
2
Remarks on result:
other: Max. duration: 48 d; Max. value at end of observation period: 0
Irritation parameter:
edema score
Basis:
mean
Score:
0
Max. score:
0
Remarks on result:
other: Max. duration: 0 d; Max. value at end of observation period: 0

Any other information on results incl. tables

Reversibility of any observed effect: Changes fully reversible within 3 days

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance was found to be not irritating to skin under the condition of the test.