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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
experimental study
Adequacy of study:
supporting study
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:
1978
Report Date:
1978

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: Federal Register 38, No. 187, § 1500.41, p. 27019
Principles of method if other than guideline:
0.5 ml of the test substance were applied to the shaved skin of rabbits under occlusive conditions for 24 hours. Skin readings were taken after 24, 48 (taken from raw data) and 72 hours as well as after 8 days. The test was also performed on abraded skin, the results are not taken into consideration.
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
Vienna White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: Gaukler
- Weight at study initiation: 2.95 - 3.03 kg


ENVIRONMENTAL CONDITIONS
no data

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.5 ml
Duration of treatment / exposure:
24 hours
Observation period:
8 days
Number of animals:
3

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24/48/72 h
Score:
2
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 48 hour reading taken from raw data
Irritation parameter:
edema score
Basis:
mean
Time point:
24/48/72 h
Score:
1.11
Max. score:
4
Reversibility:
fully reversible within: 8 days
Remarks on result:
other: 48 hour reading taken from raw data

Any other information on results incl. tables

individual scores:
erythema: 1.67 in 1/3; 2 in 1/3; 2.33 in 1/3; 
edema: 0.67 in in 1/3; 1 in 1/3; 1.67 in 1/3; 

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met