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Toxicological information

Skin irritation / corrosion

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Administrative data

Endpoint:
skin irritation: in vivo
Type of information:
other: read-across from supporting substance (structural analogue or surrogate)
Adequacy of study:
key study
Study period:
1979
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
comparable to guideline study with acceptable restrictions
Remarks:
study conducted on the analogue substance; The Reliability of the Source Study is 2.
Justification for type of information:
The read across justification is detailed in section 13.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1979
Report Date:
1979

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
other: US Department of Agriculture (Fed Reg 38, 187, 27019, 1973)
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. The test item was applied to intact and wound skin of each animal. The degree of irritation/corrosion was read and scored for oedema and erythema reactions at intervals of 24 and 72 hours.
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: singly
- Diet ad libitum
- Water ad libitum
standard conditions

Test system

Type of coverage:
semiocclusive
Preparation of test site:
other: shorn: intact and scarificed
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Duration of treatment / exposure:
24 h
Observation period:
72 h
Number of animals:
6
Details on study design:
According to the US Department of Agriculture (Fed Reg. 38, 187, 27019, 1973).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: all six
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
edema score
Basis:
animal: all six
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritant / corrosive response data:
No irritation effects were observed

Applicant's summary and conclusion

Interpretation of results:
other: not classified according to the CLP Regulation (EC) No. 1272/2008
Conclusions:
The test item was found to be not irritating to rabbit skin.
Executive summary:

The test item was investigated for skin irritating property in rabbits using a guideline given by the U.S. Department of Agriculture (Fed. Reg 38, 187, 27019, 1973). A single dose was tested on the skin of six rabbits. The test item was applied to intact and wound skin of each animal. The degree of irritation/corrosion was read and scored for oedema and erythema reactions at intervals of 24 and 72 hours.

The test item caused no irritation in the skin of rabbits.


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