Registration Dossier

Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Guideline study obtained through inquiry process; SNIF file obtained from ECHA.

Data source

Reference
Reference Type:
other: SNIF
Title:
Unnamed
Year:
1992

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

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

Test animals

Species:
rabbit
Strain:
Vienna White

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 h
Observation period:
72 h
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 1 d
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 1 d
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 1 d
Irritation parameter:
erythema score
Basis:
mean
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
mean score 1
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 1 d
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 1 d
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
0
Reversibility:
fully reversible within: 1 d
Irritation parameter:
edema score
Basis:
mean
Max. score:
0
Remarks on result:
other: Max. duration: d; Max. value at end of observation period: 0 (related to all animals)

Applicant's summary and conclusion

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