Disodium [3-[4,5-dihydro-4-[(2-hydroxy-5-nitrophenyl)azo]-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation / corrosion, other

Remarks:

An in vitro skin irritation study does not need to be conducted because adequate data from an in vivo study are available.

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

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 Brown 298

IUPAC Name:

Acid Brown 298

Test animals

Species:

rabbit

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Russian breed
- Weight at study initiation: from 1.5 to 2.0 kg
- Housing: in V2A wire cages
- Diet and water: fed with standard diet of Nafag and drinking water ad libitum

No indication about ENVIRONMENTAL CONDITIONS

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

yes, concurrent no treatment

Amount / concentration applied:

Amount of 0.5 g of test substance was applied

Duration of treatment / exposure:

The gauze patches were removed 24 hours after application

Observation period:

The reaction of the skin was appraised upon removal during an observation period of 8 days

Number of animals:

6 (3 males and 3 females) rabbits

Details on study design:

TEST SITE
- Area of exposure: The shaved skin on the left side was slightly scarified immediately before treatment. A gauze patch of 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin.
- Type of wrap if used: the patch was covered with a plastic film of 5 x 5 cm, which was fixed to the body with adesive tape.

SCORING SYSTEM: The reaction of the skin was appraised upon removal and 72 hours after it, on the basis of the following evaluation scheme.

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: all animals (3/3)

Time point:

other: mean score after 24, 48 and 72 hours

Score:

0

Reversibility:

other: No skin reaction observed

Remarks on result:

other: on intact and scarified skin

Results 2

Irritation parameter:

edema score

Basis:

animal: all animals (3/3)

Time point:

other: mean score after 24, 48 and 72 hours

Score:

0

Reversibility:

other: No skin reaction observed

Remarks on result:

other: on intact and scarified skin

Irritant / corrosive response data:

The test substance was found to be non irritant when applied to intact or scarified rabbit skin, after an observation period of 72 hours. The mean score for each animal is zero.

Applicant's summary and conclusion

Interpretation of results:

other: Not classified according to the CLP Regulation

Conclusions:

The test substance was found to be non irritant when applied to intact or scarified rabbit skin.

Executive summary:

METHOD

The skin irritation test was performed to rabbit skin using a single administration, according to the "Appraisal of the Safety of Chemicals in Food, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

RESULT/CONCLUSION

The criteria for the evaluation of the skin irritation potential followed in the test are different from those reported into the OECD guideline. Nevertheless, the scoring system used for the erythema and eschar formation and for oedema formation are the same of that reported into the OECD. Since the raw tables are included into the study report, it is possible to re-evaluate the results according to the CLP Regulation (EC n. 1272/2008).

The test substance was found to be non irritant when applied to intact or scarified rabbit skin.

Therefore, the test substance can be considered as not irritant.