Registration Dossier

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: Test was conducted according to OECD 404, Directive 84/449/EEC, B4 and compliant with GLP.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1993

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
according to
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
Deviations:
not specified
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White

Test system

Type of coverage:
semiocclusive
Vehicle:
other: Moistened with aqua pro injectione
Amount / concentration applied:
500 mg
Duration of treatment / exposure:
4 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: 3 days
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
mean score 2
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Reversibility:
fully reversible within: 3 days
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
mean score 3
Time point:
other: overall at 24, 48 and 72 h
Score:
0.7
Reversibility:
fully reversible within: 3 days
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: 3 days
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: 3 days
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: 3 days
Irritant / corrosive response data:
Reversibility of any observed effect: changes fully reversible within 3 days.

Any other information on results incl. tables

erythema score: Max. duration: 3 d; Max. value at end of observation period: 0 (related to all animals);

edema score: Max. duration: 0 d; Max.value at end of observation period: 0 (realted to all animals).

No signs of systemic toxicity were observed.

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
The test substance is not classified as irritating to the skin.