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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:
comparable to guideline study with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1982
Report date:
1982

Materials and methods

Test guideline
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
no

Test material

Constituent 1
Reference substance name:
Disperse Red 054
IUPAC Name:
Disperse Red 054

Test animals

Species:
rabbit
Strain:
New Zealand White
Details on test animals or test system and environmental conditions:
TEST ANIMALS
- Housing: aII animals were housed in single cages.
- Diet: ad libitum. The batch of the diet used for this study was analysed for chemical and microbiological contaminants.
- Health check: 24 hours prior to the test, the skin on the back of the animals was clipped by means of an electric clipper and the skin was investigated for pre-existing injuries.
- Acclimation period: all animals were acclimatized to the environment for a period of five days prior to the start of the study.

ENVIRONMENTAL CONDITIONS
- Temperature: 23 ± 2 °C
- Humidity: 50 ± 10 %
- Air changes: maintained at approximately 15 changes/hour.
- Photoperiod: light/dark cycle was 12 hours.

Test system

Type of coverage:
occlusive
Preparation of test site:
other: intact and abraded skin
Vehicle:
other: DMSO
Remarks:
test item was prepared immediately before dosing
Controls:
yes, concurrent no treatment
Amount / concentration applied:
1.0 ml of the solution.
Duration of treatment / exposure:
24 hours
Observation period:
72 hours
Number of animals:
Three males and three females
Details on study design:
TEST SITE
- Area of exposure: test item was introduced under a square patch of surgical gauze, measuring 6.5 cm^2.
- Type of wrap if used: the animals were immobilzed with patches secured in place by a plastic patch and the entire trunk was wrapped with a plastic sleeve.

SCORING SYSTEM
After 24 hours, the patches were removed and the resulting reactions were evaluated on the basis of the code of Federal Regulation, title 16, Section 1500.41.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
erythema score
Basis:
animal: 6/6
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
no indication of irritation
Remarks:
in none of the animals
Irritation parameter:
edema score
Basis:
animal: 6/6
Time point:
24/48/72 h
Score:
< 2.3
Remarks on result:
no indication of irritation
Remarks:
in none of the animals
Irritant / corrosive response data:
The irritation score resulted to be 0.
Test item resulted to be non irritant according to the systen of classification recommended by the ETAD Subcommittee for toxicity.

Applicant's summary and conclusion

Interpretation of results:
other: not classified, according to the CLP Regulation (EC 1272/2008)
Conclusions:
Not irritating
Executive summary:

Six rabbits (three males and three females) were used to test the skin irritation potential of the substance. The abraded and intact skin of rabbits was treated with 1.0 ml of test solution. The irritation was measured by patch test technique on the intact skin. After 4 hours, the patches were removed and the resulting reactions were evaluated on the basis of the code of Federal Regulations, Title 16, Section 1500.41.

None of the animals showed any observable response to treatment throughout the 72 hours observation period.

The irritation score was 0.0 and the substance has been judged to be non irritating, according to the ETAD-Subcommittee for Toxicology.

Conclusion

The scoring system criteria used to record the severity of the skin reactions followed in the current test are the same as those reported into the OECD guideline, therefore it is possible to re-evaluate the results in accordance with the CLP Regulation (EC 1272/2008).

None of the animals showed any observable response to treatment throughout the 72 hours observation period, thus it can be concluded that the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC 1272/2008).

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