Acid Brown 354

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 27th May 1997 to 3rd lune 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1992

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.4 (Acute Toxicity: Dermal Irritation / Corrosion)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of diazotized 4'-Amino-4-Nitrodiphenylamine-2-Sulfonic Acid coupled with Resorcinol, sodium salts

EC Number:

947-125-5

Molecular formula:

Not applicable for UVCB substance

IUPAC Name:

Reaction products of diazotized 4'-Amino-4-Nitrodiphenylamine-2-Sulfonic Acid coupled with Resorcinol, sodium salts

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: B & K UNIVERSAL G.J., S.L. (Sant Vincenç; dels Horts, Barcelona, Spain) on 12th May 1997 (no. 954, 958 and 972)
- Age at study initiation: 9-11 weeks.
- Weight at study initiation: 2.0-2.4 kg
- Housing: housed individually in stainless steel cages (48 x 59 x 37 cm), with a grille floor, placed on racks.
- Diet: The animals were allowed free access to a standard rabbit diet UAR 112
- Water: water was supplied ad libitum by an automatic drinking system.
- Acclimation period: 7 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 20 - 24 °C
- Humidity: 40 - 75 %
- Photoperiod: 12 hours cycle dark/light (7:00 to 19:00)

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

- Amount applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

at 1, 24, 48, 72 hours and 7th day

Number of animals:

3 rabbits

Details on study design:

TEST SITE
- Area of exposure: 6.2 cm^2
- % coverage: 2.5 x 2.5 cm^2
- Type of wrap if used: surgical gauze. The resulting patches were held close to the body using strips of adhesive tape. Finally, a strip of gauze was wrapped around the trunk of the animal in order to hold the patches in place. The gauze was fixed to the body using additional adhesive tape.

EVALUATION
The observations carried out were assessed according to the numerical scale and the degree of enythema and the formation of eschars and edema were quantified, as outlined in the OECD GUIDELINE FOR TESTING OF CHEMICALS, No. 404, of 17th July 1992.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal #1

Time point:

24/48/72 h

Score:

0.67

Reversibility:

fully reversible within: 72 hours

Results 2

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1

Reversibility:

fully reversible within: 7 days

Results 3

Irritation parameter:

erythema score

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Results 4

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Other effects:

Clinical signs:
The behaviour and physical condition of the rabbits were normal throughout the Study.

Any other information on results incl. tables

Very slight, practically not noticeable, erythema (grade 1) was observed in all the animals as well as a yellow staining of the administered areas. Similarly, one ofthe animals was observed to present very slight edema (grade 1).

In the readings carried out at 24 -48 hours after removing the patches two of the animals continued to show very slight eiythema (grade 1) while the yellow staining of the administered areas was still observed in all the animals. At 72 hours, this presence of the yellow staining was still noted and only one animal continued to show very slight eiythema (grade 1). In the additional reading carried out 7 days post-treatment, the erythema had disappeared while the yellow staining remained in one ofthe animals.

Applicant's summary and conclusion

Interpretation of results:

other: not classified according to the CLP Regulation (EC) no. 1272/2008

Conclusions:

The test item resulted not be irritating to the rabbit skin.

Executive summary:

The degree of skin irritation caused by the substance was determined after its application to shaved rabbit skin, according to the OECD Guideline No. 404 (1992) and the method B.4 of the EEC Guidelines of 31st July 1992 (92/69/EEC). The substance was applied using a semi-occlusive patch, left for 4 hours.

The mean values (24/48/72 h) for edema scores were 0 in all animals; for erythema scores were 0.67, 1 and 0 in animals #1, #2 and #3 respectively. All the effects observed were fully reversible within the 7day-study period.