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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
Study period:
1981
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
No data on test animals and environmental conditions, 24 h exposure period, occlusive dressing used, observation at 24 and 72 h only, full reversibility not observed.
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1981
Report Date:
1981

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
yes
Remarks:
No data on test animals and environmental conditions, 24 h exposure period, occlusive dressing used, observation at 24 and 72 h only, full reversibility not observed.
Principles of method if other than guideline:
Not applicable
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Test material form:
solid
Remarks:
paste
Details on test material:
- Description: White pasty product
- Date of receipt: 10 September 1980
Specific details on test material used for the study:
Test substance was tested pure and undiluted

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
No data

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact or abraded skin
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Concentration (if solution): Undiluted
Duration of treatment / exposure:
24 hours
Observation period:
24 and 72 h after the application of the test substance
Number of animals:
6 animals - intact skin
6 animals - abraded skin
Details on study design:
PRE-TREATMENT
24 hours prior to the test, the hair was removed from the backs of the animals with an electric clipper in such a way as to avoid abrasions.

TEST SITE
- Area of exposure: Test substance was applied on the intact or abraded skin under a surgical patch measuring 1 inch x 1 inch.
- Type of wrap if used: The patches were fixed to the application site by means of adhesive tape and the entire trunk of the rabbits was wrapped with an impervious material.

OBSERVATION TIME POINTS
24 and 72 h after the application of test substance

SCORING SYSTEM:
Skin reactions were evaluated by the method of Draize, 1944

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
intact skin
Time point:
other: 24 and 72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
intact skin
Time point:
other: 24 and 72 h
Score:
1.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
intact skin
Time point:
other: 24 and 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #4
Remarks:
intact skin
Time point:
other: 24 and 72 h
Score:
1.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #5
Remarks:
intact skin
Time point:
other: 24 and 72 h
Score:
1.5
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
erythema score
Basis:
animal #6
Remarks:
intact skin
Time point:
other: 24 and 72 h
Score:
2
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
intact skin
Time point:
other: 24 and 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
intact skin
Time point:
other: 24 and 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
intact skin
Time point:
other: 24 and 72 h
Score:
0
Max. score:
4
Reversibility:
other: not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #4
Remarks:
intact skin
Time point:
other: 24 and 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #5
Remarks:
intact skin
Time point:
other: 24 and 72 h
Score:
0.5
Max. score:
4
Reversibility:
fully reversible within: 72 h
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal #6
Remarks:
intact skin
Time point:
other: 24 and 72 h
Score:
1
Max. score:
4
Reversibility:
not specified
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
- Test substance caused slight to moderate skin irritation. Its dermal effects generally consisted of very slight or well-defined erythema, very slight edema and slight scaliness.
- There were no significant differences between skin reactions of the intact skin and those of the abraded skin.
Other effects:
None

Any other information on results incl. tables

Table 7.3.1/1: Individual and average skin irritation scores

Rabbit No.

Intact skin

Rabbit No.

Abraded skin

Erythema

Edema

Erythema

Edema

24 h

72 h

24 h

72 h

24 h

72 h

24 h

72 h

1

3

1

1

0

7

0

0

0

0

2

2

1

1

0

8

2

1

1

0

3

1

0

0

0

9

1

0

0

0

4

2

1

1

0

10

2

1

1

0

5

2

1

1

0

11

1

1

1

0

6

2

2

1

1

12

2

1

1

0

Total

12

6

5

1

Total

8

4

4

0

Mean (24 and

72 h)

1.5

0.5

Mean (24 and

72 h)

1.0

0.3

Applicant's summary and conclusion

Interpretation of results:
Category 3 (mild irritant) based on GHS criteria
Conclusions:
Under the test conditions, test substance is not classified as irritating to skin according to the criteria of the annex VI of the Regulation EC No. 1272/2008 (CLP) and classified in Cat.3 (mild skin irritation) according to the GHS.
Executive summary:

In a dermal irritation study, undiluted test substance was dermally applied on the intact or abraded side surface of 12 New Zealand White rabbits. Test sites were covered with an occlusive dressing for 24 h. Skin irritation was assessed and scored according to the Draize scale at 24 and 72 h after the application of test substance.

 

Test substance caused slight to moderate skin irritation. Its dermal effects generally consisted of very slight or well-defined erythema, very slight edema and slight scaliness. There were no significant differences between skin reactions of the intact skin and those of the abraded skin. Mean scores were 1.5 for erythema and 0.5 for edema (intact skin) and 1.0 for erythema and 0.3 for edema (abraded skin).

 

Under the test conditions, test substance is not classified according to the criteria of the annex VI of the Regulation EC No. 1272/2008 (CLP) ant classified in Cat.3 according to the GHS.

Although some details on test animals and experimental conditions were missing, this study is considered as acceptable and satisfies the requirement for skin irritation endpoint.