Disodium ar,ar'-[(9,10-dihydro-9,10-dioxo-1,4-anthrylene)diimino]bis[(4-chlorophenoxy)benzenesulphonate]

Skin irritation / corrosion

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:

1975

Report date:

1975

Materials and methods

Principles of method if other than guideline:

The procedure employed was that described by the Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.41.

GLP compliance:

no

Remarks:

pre GLP

Test material

Test material information

Constituent 1

Reference substance name:

Acid Green 040

IUPAC Name:

Acid Green 040

Test animals

Species:

rabbit

Test system

Type of coverage:

occlusive

Preparation of test site:

other: abraded and intact skin

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

0.5 g of test item were mixed with 0.5 ml of distilled water

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

six rabbits

Details on study design:

TEST SITE
- Area of exposure: two slngle layers thick moinstoned with test item were introduce under a square patch such as surgical gauze measuring 1 inch x 1 inch.
- Type of wrap if used: the entire trunk of the animal was wrapped with an impervious material such as rubberized cloth.

SCORING SYSTEM
Readings are again made at the end of a total of 72 hours (48 hours after the first reading). An equal number of exposures are made on areas of skin that have been previously abraded. The abrasions are minor incisions through the stratum corneum, but not sufficiently deep to disturb the derma or to produce bleeding. Evaluate the reactions of the abraded skinat 24 hours and 72 hours. Add the values for erythema and eschar formation at 24 hours and at 72 hours for intact skin to the values on abraded skin at 24 hours and at 72 hours (four values). Slmilarly, add the values for oedema formation at 24 hours and at 72 hours for intact and abraded skln (four values). The total of the eight values is divlded by four to give the primary irritation score.

Erythema and eschar formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well-defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar formation (injuries in depth) 4

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well-defined by definite raising) 2
Moderate oedema ( ratsed approximately I milllmeter) 3
Severe oedema (raised more than 1 miillimeter and extending beyond the area of exposure) 4

Classification system recommended by the ETAD subcommittee for Toxicology:
0 - 0.5 non-irritant
0.6 - 3.0 slightly irritant
3.1 - 5.0 moderately irritant
5.1 - 8.0 severely irritant

Results and discussion

In vivo

Results

Results 1

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:

none of the animals showed any observable response

Results 2

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:

none of the animals showed any observable response

Irritant / corrosive response data:

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

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

Not irritating

Executive summary:

Primary irritation to the skin was assayed following the procedures prescribed by The Consumer Product Safety Commission of the U.S.A. in The Code of Federal Regulations, Title 16, Section 1500.41. 0.5 g of test item were rnixed with 0.5 ml of distilled water before application to the skin. The primary irritation was measured by a patch technique on both abraded and intact skin of albino rabbits.

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

Conclusion

The scoring system criteria used to record the hardness 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) No 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) No 1272/2008.