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
Study period:
1969
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1969
Report Date:
1970

Materials and methods

Principles of method if other than guideline:
Method: other: BASF test
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 2.72 and 2.25 kg

Test system

Type of coverage:
not specified
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
15 minutes and 20 hours
Observation period:
8 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: back and ear

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of two animals
Time point:
24/48/72 h
Score:
3.2
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 20h treatment
Irritation parameter:
edema score
Basis:
mean
Remarks:
of two animals
Time point:
24/48/72 h
Score:
3.5
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 20 h treatment
Irritation parameter:
erythema score
Basis:
mean
Remarks:
of two animals
Time point:
24 h
Score:
3
Max. score:
4
Reversibility:
not fully reversible within: 8 days
Remarks on result:
other: 15 minute treatment
Irritant / corrosive response data:
Necroses were observed after 20h treatment

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritant) based on GHS criteria