Reaction mass of trisodium [m[7-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-8-hydroxynaphthalene-1,6-disulphonato(7-)]]dicuprate(3-) and trisodium [m[4-[[4'-[[6-benzamido-1-hydroxy-3-sulpho-2-naphthyl]azo]-3,3'-dihydroxy[1,1'-biphenyl]-4-yl]azo]-3-hydroxynaphthalene-2,7-disulphonato(7-)]]dicuprate(3-)

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:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Direct Blue 251

IUPAC Name:

Direct Blue 251

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Housing: all animals were housed in single cages.
- Diet: a standard laboratory diet was provided ad libitum. The batch of the diet used for this study was analysed for chemical and microbiological contaminants.
- Water: water was provided ad libitum.
- 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: the room temperature was maintained within a median of 21 ± 2 °C recorded by a maximum-minimum thermometer.
- Humidity: 30 - 70 %, measured by a hygrometer.
- Air changes: the rate of air exchange was maintained at approximately 15 changes/hour.
- Photoperiod: the light/dark cycle was 12 hours.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: the substance was diluted with WEM (50 %)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

1.0 ml of solution

Duration of treatment / exposure:

4 hours

Number of animals:

Three male rabbits

Details on study design:

TEST SITE
- Area of exposure: 24 hours prior to the test, the skin on the back of the animals was clipped and the skin was investigated for pre-existing injuries. Test item was applied by surgical gauze, measuring 6.5 cm2.
- Type of wrap if used: the animals were immobilized with patches secured in place by a plastic patch and the entire trunk was wrapped with a plastic sleeve.

SCORING SYSTEM
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 Regulation, Title 16, Section 1500.41.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

The irritation score resulted 0.00, thus the substance was considered to be non-irritant.

Any other information on results incl. tables

Individual reactions

Animal	Reaction	30 min	24 hrs	48 hrs	72 hrs	Mean 24/48/72 hrs
Animal 1	Erythema	0	0	0	0	0
Animal 2	Erythema	0	0	0	0	0
Animal 3	Erythema	0	0	0	0	0
Animal 1	Oedema	0	0	0	0	0
Animal 2	Oedema	0	0	0	0	0
Animal 3	Oedema	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

Non-irritant

Executive summary:

Three male rabbits were used to assay the skin irritation potential of the test item. 1.0 ml of the solution (test item diluted with WEM (50 %)) were placed on the surgical gauze and place in contact with skin over a period of 4 hours. 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 Regulation, Title 16, Section 1500.41.

The irritation score resulted 0.00, thus the substance was considered to be non-irritant.

Conclusion

Although the criteria for the evaluation of the skin irritation potential followed in the test are different from those reported into the OECD guideline, the scoring system is the same. Because the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC) No 1272/2008. The mean values from gradings at 24, 48 and 72 hours were lower than 2.3 for both the erythema and oedema. Thus the substance does not meet the criteria to be classified as skin irritating, according to the CLP Regulation (EC) No 1272/2008.