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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:
1983
Report Date:
1983

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
- Principle of test: The test substance was assessed for skin irritation in rabbits.
- Short description of test conditions: Two animals were exposed to 500 mg of the test substance on the flank for 24 h. Animals were observed for 7 days.
- Parameters analysed / observed: reddening and swelling
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Weight at study initiation: 3 - 4 kg
- Housing: individually

Test system

Type of coverage:
not specified
Preparation of test site:
not specified
Vehicle:
not specified
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0.5 g
Duration of treatment / exposure:
24 h
Observation period:
7 days
Number of animals:
2
Details on study design:
TEST SITE
- Area of exposure: flank
- Type of wrap if used: Band-Aids

REMOVAL OF TEST SUBSTANCE
- Washing: with water, soap and vegetable oil
- Time after start of exposure: 24 h

OBSERVATION TIME POINTS
directly after test substance removal, after 24 and 48 h and after 7 days

SCORING SYSTEM:
- Method of calculation: Draize scoring system

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal #1
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
erythema score
Basis:
animal #2
Time point:
24/48 h
Score:
4
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #1
Time point:
24/48 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritation parameter:
edema score
Basis:
animal #2
Time point:
24/48 h
Score:
2.5
Max. score:
4
Reversibility:
not fully reversible within: 7 days
Irritant / corrosive response data:
Necrotic changes of the skin in the area of treatment were observed on the first, second and seventh day of the observation period.

Any other information on results incl. tables

Table 1: Grades for Dermal Irritation

Animal no.

Erythema

Edema

0 h*

24 h

48 h

7 d

0 h*

24 h

48 h

7 d

41

4

4

4

4

4

3

2

2

51

4

4

4

4

4

3

2

2

* directly after test substance removal

Applicant's summary and conclusion

Interpretation of results:
Category 1 (corrosive) based on GHS criteria
Conclusions:
The findings clearly indicate that the test compound caused irreversible damage to the skin which in terms of classification according to Regulation (EC) No 1272/2008 implies classification as Skin Corr. 1, H314.
Executive summary:

A study for dermal irritation in the rabbit was conducted with the test substance. Two New Zealand White rabbits received 0.5 g of the test substance to the flank for 24 h. After exposure duration the test substance was removed by washing with water, soap and vegetable oil. The treated skin surface was examined directly after test substance removal, at 24 and 48 h as well as at 7 days after removal. The Draize scale was used for scoring the skin reactions. Deep reddening (erythema score 4) was noted in both animals at all reading time points. Both animals exhibited severe swelling at the application site (score 4) after test substance removal which was not fully reversible up to the end of the 7-day observation period (score 3 at 24 h, score 2 at 48 h and 7 days after test substance removal in both animals). Necrotic changes of the skin in the area of treatment were observed on the first, second and seventh day of the observation period. Thus, under the conditions of this study, the test substance is corrosive to the skin which in terms of classification according to Regulation (EC) No 1272/2008 implies classification as Skin Corr. 1, H314: Causes severe skin burns and eye damage.