Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

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:
supporting study
Study period:
1986
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Remarks:
The test was conducted by means of Read Across approach. Further information was attached at section 13. Reliability of the original study is 1.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1986
Report date:
1986

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
Deviations:
not specified
Qualifier:
equivalent or similar to guideline
Guideline:
EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Reference substance name:
Similar Substance 02 - ABk071
IUPAC Name:
Similar Substance 02 - ABk071

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
The test was performed on 1male and 2 female rabbits, weighing between 2.5 to 3.0 kg (approx. 15-16 weeks old). The acclimation was 4 days under laboratory conditions after veterinary examination. Body weights were measured on day 1 and at termination of test.

Test system

Type of coverage:
occlusive
Preparation of test site:
shaved
Vehicle:
other: moistened with tap water
Controls:
yes, concurrent no treatment
Amount / concentration applied:
on the test day 1, 0.5g test article was applied to the intact skin of the shaved area. The test article was moistened with tap water.
Duration of treatment / exposure:
four hours
Observation period:
at 1, 24, 48, 72 hrs intervals after the removal of the dressing, gauze patch and test article.
Number of animals:
1 male and 2 females
Details on study design:
Approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters(10×10cm). On test day 1, 0.5g of the test article was applied to the intact skin of the shaved area. It was covered with a 3.0×3.0 cm patch of surgical gauze. The gauze was covered with aluminum foil and then covered with an occlusive dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage. Four hrs after the application, the dressing was removed and the skin was flushed with lake warm tap water.
at 1,24,48,72 hrs after patch removal, any lesions, a description of the degree and nature of irritation, corrosion or reversibility, and any other toxic effects observed.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
other: mean score 1 male and 2 females
Time point:
other: 1 hr
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
other: mean score 1male and 2 females
Time point:
other: 24
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
other: mean score 1 male and 2 females
Time point:
other: 48 hrs
Score:
0
Max. score:
4
Irritation parameter:
erythema score
Basis:
other: mean score 1 male and 2 females
Time point:
other: 72 hrs
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
other: mean score 1 male and 2 females
Time point:
other: 1 hr
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
other: mean score 1 male and 2 females
Time point:
other: 24 hrs
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
other: mean score 1 male and 2 females
Time point:
other: 48 hrs
Score:
0
Max. score:
4
Irritation parameter:
edema score
Basis:
other: mean score 1 male and 2 females
Time point:
other: 72 hrs
Score:
0
Max. score:
4
Other effects:
In the area of application a black discoloration of the skin was observed.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Conclusions:
The substance was not found to cause a primary skin irritation when applied to intact rabbit skin.
Executive summary:

There were 1 male and 2 female rabbits used in this test under the standard laboratory conditions. In the area of application a black discoloration of the skin was observed which could be related to effects of the test article. No destructions or irreversible alterations of the treated skin were observed. No corrosive effect was evident on the skin. The body weight gain of all rabbits was similar. No acute toxic symptoms were observed in the animals during the test period, and no mortality occurred. Under the conditions of this experiment, the substance was found to cause a primary irritation score of 0 when applied to intact rabbit skin, which shall not be classified acorrding to CLP regulation (Regulation EC No. 1272/2008).