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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: experimental study on similar substance
Adequacy of study:
key study
Study period:
1974
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: 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:
The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).
GLP compliance:
not specified

Test material

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

Test animals

Species:
rabbit
Strain:
other: Russian breed

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: PEG 400
Controls:
other: the untreated skin is used as a control.
Amount / concentration applied:
The tested substance was applied to each side in quantities of 0.5 g. Before applications a 50% polyethylene glycol (PEG 400) trituration was made.
Duration of treatment / exposure:
24 h
Observation period:
up to 72 h
Number of animals:
six rabbits: 3 male and 3 female

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
mean
Time point:
24 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
erythema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
erythema score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
24 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Irritation parameter:
edema score
Basis:
mean
Time point:
48 h
Remarks on result:
not measured/tested
Irritation parameter:
edema score
Basis:
mean
Time point:
72 h
Score:
ca. 0
Max. score:
4
Reversibility:
other: not applicable
Irritant / corrosive response data:
The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.

Any other information on results incl. tables

The results of the skin irritation test are summarized in Table 1.

Animal

No.

Sex

Skin Reaction

24 hrs after application

 72 hrs after application

intact

skin

scarified

skin

intact

skin

scarified

skin

1     m

Erythema

0

0

0

0

 

Edema

0

0

0

0

2    m

Erythema

0

0

0

0

 

Edema

0

0

0

0

3    m

Erythema

 

0

0

0

0

 

Edema

0

0

0

0

4    f

Erythema

0

0

0

0

 

Edema

0

0

0

0

5    f

Erythema

0

0

0

0

 

Edema

0

0

0

0

6    f

Erythema

0

0

0

0

 

Edema

0

0

0

0

The primary irritation index as the measure of the acute skin irritation provoked by the substance is defined as the average of all the ratings found after 24 and 72 hours on the intact and slightly scarified skin. Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; whereas those with indexes from 2 to 5 are moderate irritants, and those v/ith scores above 6 are considered severe irritants.

The primary irritation index of the tested item was 0.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.
Therefore the tested item is to be considered as non-irritant to the skin of rabbits.
Executive summary:

The primary irritation effect was assessed following the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

The result show no irritation on rabbit skin therefore the tested item is to be considered as non-irritant to skin.