Reaction products of 6-amino-4-hydroxynaphthalene-2-sulphonic acid and 7-amino-4-hydroxynaphthalene-2-sulphonic acid, condensed with Formaldehyde and Sodium hydrogensulfite, coupled with diazotised Sodium 2-amino-4,6-dinitrophenoxide, metalized with Sodium Dichromate, sodium salts

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

guideline study with acceptable restrictions

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 6-amino-4-hydroxynaphthalene-2-sulphonic acid and 7-amino-4-hydroxynaphthalene-2-sulphonic acid, condensed with Formaldehyde and Sodium hydrogensulfite, coupled with diazotised Sodium 2-amino-4,6-dinitrophenoxide, metalized with Sodium Dichromate, sodium salts

EC Number:

947-452-3

Molecular formula:

not applicable

IUPAC Name:

Reaction products of 6-amino-4-hydroxynaphthalene-2-sulphonic acid and 7-amino-4-hydroxynaphthalene-2-sulphonic acid, condensed with Formaldehyde and Sodium hydrogensulfite, coupled with diazotised Sodium 2-amino-4,6-dinitrophenoxide, metalized with Sodium Dichromate, 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: 2,588 kg.
- Housing: the rabbits were individually housed 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, witham, Essex, England) during the study.
- Water: the animals had free access to tap water filtered with Millipore filters in water bottles
- Acclimation period: 7 days. During this period, the animals were observed daily.

ENVIRONMENTAL CONDITIONS
- Temperature: 18°C ± 3 °C
- Humidity: 50 ± 20 %.
- Air changes: the incoming, non-recycled air, was filtered by ani absolute filter.
- Photoperiod: The light/dark cycle was 12 hours per day.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

yes

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

VEHICLE
- Amount applied: the substance has been moistened with some drops of distilled water to prevent loss of material.

Duration of treatment / exposure:

4 hours

Observation period:

followed by an observation period of 3 days

Number of animals:

6 male rabbits

Details on study design:

TEST SITE
- Area of exposure: 6 cm²
- Type of wrap if used: each animal and then covered by a hydrophilic gauze patch (Codex).
The test sample and the gauze patch were held in contact with the skin by means of a semi-occlusive patch and adhesive tape.

REMOVAL OF TEST SUBSTANCE
- Washing: test sample was removed by means of 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 recorded during the study.
-Clinical sings:No cutaneous reactions,erythema or oedema appeared 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:

An acute dermal irritation study was performed with the test item in six male New Zealand rabbits, according to the OECD Guideline 404 (1981). No mortality was recorded during the study and no cutaneous reactions appeared during the observation period study. The erythema and oedema scores were 0 in all animals.