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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:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1974
Report Date:
1974

Materials and methods

Principles of method if other than guideline:
In order to evaluate the primary skin irritation of the substance, a single dose was tested on the skin of six rabbits. 0.5 g of test substance was applied to intact and wound skin of each animal using a 25 cm^2 sticking plaster. The degree of irritation/corrosion was read and scored for oedema and erythema reactions at intervals of 24 and 72 hours.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder

Test animals

Species:
rabbit
Strain:
not specified

Test system

Type of coverage:
semiocclusive
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not specified
Amount / concentration applied:
0.5 g
Observation period:
24 and 72 h
Number of animals:
6
Details on study design:
TEST SYSTEM
-Test site: intact and wound skin
-Type of wrap: 25 cm^2 sticking plaster

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: all animals (6/6)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal: all animals (6/6)
Time point:
24/48/72 h
Score:
0

Any other information on results incl. tables

As the observations time were only at 24 and 72 h, for mean calculations of 24/48/72 h it was used the worst case approach using the higher score at 48 h.

Applicant's summary and conclusion

Interpretation of results:
other: Not classified according to the CLP Regulation (EC 1272/2008)
Conclusions:
The test substance was found to be non irritant when applied to intact rabbit skin.
Executive summary:

The skin irritation test was performed to rabbit skin according to an internal method: a single dose was tested on the skin of six rabbits. 0.5 g of test substance was applied to intact and wound skin of each animal using a 25 cm2 sticking plaster. The degree of irritation/corrosion was read and scored for oedema and erythema reactions at intervals of 24 and 72 hours. The erythema and the oedema scores were calculated following the mean values after 24/48/72 h. For the scores at 48 h the greater value observed during the test was considered, as no observation was performed at this time-point. The erythema and oedema scores (mean values 24/48/72 hours) were 0 in all animals.