disodium [N, 2-[(2-hydroxy-5-nitrophenyl)azo]-3-oxobutyramidato(2-)][3-hydroxy-4-[(2-hydroxy-1-naphthyl)azo]-7-nitronaphthalene-1-sulphonato(3-)]chromate(2-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

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

Adequacy of study:

weight of evidence

Study period:

December 1977

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:

1977

Report date:

1977

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics by The Association of Food & Drug Officials of the United States (1959)

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Green 073:2

IUPAC Name:

Acid Green 073:2

Test material form:

not specified

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: himalayan breeder
- Weight at study initiation: 1.5 to 2 kg
- Housing: housed individually in metal cages
- Diet (e.g. ad libitum): rabbit food - NAFAG, Gossau SG - ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: minimum of 4 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 1°C
- Humidity (%): 55 ± 5 %
- Photoperiod (hrs dark / hrs light): 14 hours dark / 10 hours light

Test system

Type of coverage:

occlusive

Preparation of test site:

other: shaved and abraded

Vehicle:

not specified

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied: 0.5 ml

Duration of treatment / exposure:

24 hours exposure

Observation period:

24 and 72 hours

Number of animals:

3 males and 3 females

Details on study design:

TEST SITE
- Type of wrap: gauze patches of 2.5 x 2.5 cm

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: intact skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

other: 24, 48 and 72 hours

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: intact skin

Applicant's summary and conclusion

Interpretation of results:

other: CLP criteria not met

Conclusions:

Not skin irritant

Executive summary:

Method

The procedure used was the patch test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959), the US Association of Food and Drug Officials (AFDO).

The test was performed on 3 male and 3 female rabbits of the Himalayan breed, housed individually in metal cage. The animals received ad libitum standard rabbit food and water. Prior to treatment they were adapted for a minimum of 4 days.

Two days before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on the left side was slightly scarified.

For treatment gauze patches of 2.5 x 2.5 cm with test material were applied to the prepared abraded and non abraded skin. The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 hour exposure.

The skin irritation was scored immediately and 48 hours after removal of the dressings (24 and 72 hours after initiation of treatment).

Results

Not irritant