Reaction mass of sodium 7-hydroxy-8-((E)-(4-(1-(4-((E)-(4-hydroxyphenyl)diazenyl)phenyl)cyclohexyl)phenyl)diazenyl)naphthalene-1,3-disulfonate and sodium 8,8'-(1E,1'E)-(4,4'-(cyclohexane-1,1-diyl)bis(4,1-phenylene))bis(diazene-2,1-diyl)bis(7-hydroxynaphthalene-1,3-disulfonate)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

other: read-across from supporting substance (structural analogue or surrogate)

Remarks:

the tested substance is one of the two components of the substance under registration

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Justification for type of information:

The tested substance is one of the two components of the substance under registration.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

GLP compliance:

no

Remarks:

pre GLP

Test material

Test material information

Constituent 1

Reference substance name:

Acid Orange 033_constituent 1

IUPAC Name:

Acid Orange 033_constituent 1

Test animals

Species:

rabbit

Strain:

not specified

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: russian breed.
- Weight at study initiation: 2.2 to 3.2 kg.
- Acclimation period: at least 8 days.
- Housing: animals were housed singly in metal cages (overall dimensions 47x32x34 cm).
- Diet: standard diet of Nafag, ad libitum.
- Water: drinking water, ad libitum.

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 1 °C
- Relative humidity: 55 ± 5 %
- Photoperiod: 14 hours light/day

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g .

VEHICLE
Before application the test material was wetted with tap water.

Duration of treatment / exposure:

Gauze patches were removed 24 hours after application.

Observation period:

8 day

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Preparation of the trated area: animals were shaved one day before treatment with an electric clipper on the flanks. The shaved skin area on the left side was slightly scarified immediately before treatment.
- Type of wrap if used: gauze patch of 2.5x2.5 cm laden with the test substance was applied to the prepared skin.The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape.

SCORING SYSTEM
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
Total possible erythema score 4

Edema Formation
No edema 0
Very slight edema (barely perceptible) 1
Slight edema (edges of area well defined by definite raising) 2
Moderate edema (raised approximately 1 mm) 3
Severe edema (raised more than 1 mm and extending beyond area of exposure) 4
Total possible edema score 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 3/3

Time point:

other: 24, 48, 72 hours

Score:

< 2.3

Remarks on result:

other: both intact and abraded skin

Results 2

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

other: 24, 48, 72 hours

Score:

< 2.3

Remarks on result:

other: both intact and abraded skin

Irritant / corrosive response data:

Under the conditions of this experiment, test item was found to be non irritant when applied to the intact or abraded rabbit skin.

Any other information on results incl. tables

Evaluation of the skin reactions - intact skin

Effect	Animal N.	After
		24 hrs	48 hrs	72 hrs	4d	6d	8d
Erythema	114 M	0	0	0	0	0	0
	42 M	0	0	0	0	0	0
	161 M	0	0	0	0	0	0
	116 F	0	0	0	0	0	0
	113 F	0	0	0	0	0	0
	115 F	0	0	0	0	0	0
Oedema	114 M	0	0	0	0	0	0
	42 M	0	0	0	0	0	0
	161 M	0	0	0	0	0	0
	116 F	0	0	0	0	0	0
	113 F	0	0	0	0	0	0
	115 F	0	0	0	0	0	0

Evaluation of the skin reactions - abraded skin

Effect	Animal N.	After
		24 hrs	48 hrs	72 hrs	4d	6d	8d
Erythema	114 M	0	0	0	0	0	0
	42 M	0	0	0	0	0	0
	161 M	0	0	0	0	0	0
	116 F	0	0	0	0	0	0
	113 F	0	0	0	0	0	0
	115 F	0	0	0	0	0	0
Oedema	114 M	0	0	0	0	0	0
	42 M	0	0	0	0	0	0
	161 M	0	0	0	0	0	0
	116 F	0	0	0	0	0	0
	113 F	0	0	0	0	0	0
	115 F	0	0	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC 1272/2008)

Conclusions:

Not irritating

Executive summary:

Method

The substance has been tested for skin irritation according to the patch test technique, as described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). 6 rabbits of the Russian were shaved one day before treatment with an electric clipper on the flanks and the shaved skin area on the left side was slightly scarified immediately before treatment. Test item was applied to each side in quantities of 0.5 g. Before application the test material was wetted with tap water. The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 8 days.

Results

Under the conditions of the present experiment, the test preparation was found to cause none irritation when applied to intact and abraded rabbit skin. The substance does not cause any signs of irritation.