Reaction products of diazotised 4'-aminoazobenzene-4-sulphonic acid, coupled with resorcinol and diazotised sodium 4-aminobenzenesulfonate, sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1984

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1985

Report date:

1985

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

1981

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Reaction products of diazotised 4'-aminoazobenzene-4-sulphonic acid, coupled with resorcinol and diazotised sodium 4-aminobenzenesulfonate, sodium salts

EC Number:

612-722-9

Cas Number:

61931-07-5

Molecular formula:

not applicable

IUPAC Name:

Reaction products of diazotised 4'-aminoazobenzene-4-sulphonic acid, coupled with resorcinol and diazotised sodium 4-aminobenzenesulfonate, 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: Abbaye de Bellefontaine (49122 Bégrolles en Mauges, France)
- Weight at study initiation: 2.5 kg
- Housing: the rabbits were individuallyhoused in polystyrene cages (0,35 x 0,55 x 0,32 m). Each cage was equipped with a food container and a water bottle.
- Diet: the animals were fed ad libitum with a certified pelleted diet Rabbit Diet SQC (Special Diets Services Ltd, Nitham, Essex, England) during the study. Analytical results for major food contaminants (pesticides, heavy metals, mycotoxins, etc..) were made available by the supplier.
- Water: the animals had free access to tap water filtered with Millipore filters, in water bottles.
- Acclimation period: 7 days

ENVIRONMENTAL CONDITIONS
- Temperature: 18 ± 3 °C
- Humidity: 50 ± 20 %
- Air changes: the animals were maintained in an air conditioned room. The incoming, non-recycled air, was filtered by an absolute filter (0.3 micron).
- Photoperiod: the light/dark cycle was 12 hours per day.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

unchanged (no vehicle)

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g of the test sample

Duration of treatment / exposure:

4 hours

Observation period:

A single application was followed by an observation period of three days.

Number of animals:

6 males

Details on study design:

TEST SITE
-Area of exposure: 6 cm²
-Type of wrap if used: covered by a hydrophilic patch Codex moistened with some drops of distilled water (lot n° 1145, Biosédra, 92240 Malakoff, France) to prevent loss of material, and held in contact with the skin.

REMOVAL OF TEST SUBSTANCE
-Washing (if done): the patch was taken off and the residual test sample was removed by means (Hi a gauze saturated with sterile pyrogen-free water.

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
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

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: #1.#2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

animal: #1.#2, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Other effects:

-Mortality:
No mortality was observed

-Clinical signs
No cutaneous reaction erythema or oedema was noted during the study

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The substance was found to be not irritating for rabbit skin.

Executive summary:

The acute dermal irritation potential of the test item was evaluated in an in vivo study according to the OECD Guideline 404 (1981). 0.5 g of test item was applied on the clipped skin of six rabbits using a semi-occlusive patch; the right flank untreated was used as control.

No cutaneous reaction was observed. The erythema and oedema scores (mean values 24/48/72 h) were 0 in all animals.