Registration Dossier

Registration Dossier

Diss Factsheets

Toxicological information

Skin irritation / corrosion

Currently viewing:

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
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

Constituent 1
Reference substance name:
Similar Substance 01
IUPAC Name:
Similar Substance 01

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system 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.

Categories Display

EU Privacy Disclaimer

This website uses cookies to ensure you get the best experience on our websites.