reaction mass of: pentasodium bis[6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III);tetrasodium [6-anilino-3,5'-disulfonatonaphthalene-2-azobenzene-1,2'-diolato][6-anilino-5'-sulfamoyl-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III);trisodium bis[6-anilino-5'-sulfamoyl-3-sulfonatonaphthalene-2-azobenzene-1,2'-diolato]cobaltate(III)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2002

Report date:

2002

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 (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

444-290-0

EC Name:

-

Cas Number:

508202-43-5

Molecular formula:

Not applicable

IUPAC Name:

tricobalt(3+) dodecasodium tris(2-[2-(2-oxido-5-sulfamoylphenyl)diazen-1-yl]-6-(phenylamino)-3-sulfonatonaphthalen-1-olate) tris(2-[2-(2-oxido-5-sulfonatophenyl)diazen-1-yl]-6-(phenylamino)-3-sulfonatonaphthalen-1-olate)

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
-Source: Elevage Scientifique des Dombes F-01400 Chatillon sur Chalaronne / France
-Age at study initiation:
♂ 12 weeks
♀ 11 weeks
-Weight at study initiation:
♂ 2080 g
♀ 1985-2038 g
-Housing: individually in stainless steel cages equipped with feed hoppers and drinking water bowls. Wood blocks (RCC Ltd, Füllinsdorf) and haysticks 4646 (batch no. 0205, Provimi Kliba AG) were provided for gnawing.
-Diet: pelleted standard Provimi Kliba 3418 rabbit maintenance diet ad libitum (batch no. 64/02) provided by Provimi Kliba AG, CH-4303 Kaiseraugst.
-Water: community tap water from Füllinsdorf, ad libitum.

ENVIRONMENTAL CONDITIONS
-Temperature: 17-23 °C
-Humidity: 30-70 %
-Air changes: 10-15 air changes per hour
-Photoperiod: 12 hours cycle dark/light
-Other: music was played during the daytime light period.

Test system

Type of coverage:

semiocclusive

Preparation of test site:

clipped

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
-Amount applied: 0.5 g was moistened with approximately 0.1 ml of purified water before application.

Duration of treatment / exposure:

4 hours

Observation period:

10 days

Number of animals:

3 (1 ♂ and 2 ♀)

Details on study design:

TEST SITE
-Area of exposure: 10 cm * 10 cm
-% coverage: 4 cm * 4 cm
-Type: surgical gauze patch (applied to the intact skin of the clipped area), covered with a semi-occlusive dressing (wrapped around the abdomen and anchored with tape)

REMOVAL OF TEST SUBSTANCE
-Washing: the skin was flushed with lukewarm tap water to clean the application site
-Time after start of exposure: after 4 hours

OBSERVATION TIME POINTS
1, 24, 48 and 72 hours as well as 7 and 10 days after the removal of the dressing, gauze patch and test item.

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

Time point:

24/48/72 h

Score:

0

Results 2

Irritation parameter:

edema score

Basis:

animal: #1, #2, #3

Time point:

24/48/72 h

Score:

0

Irritant / corrosive response data:

IRRITATION
The test item did not elicit any skin reactions at the application site of any animal at any of the observation times (all scores 0). The individual mean score for erythema/eschar and oedema for each of the three animals was therefore 0.

CORROSION
No irreversible alterations of the treated skin were observed nor were corrosive effects evident on the skin.

Other effects:

COLORATION
The test item caused a marked violet coloured staining at the test site of all animals 1 hour after removal of the dressing. A light violet staining continued to be observed in one animal up to the 72-hour examination and in the remaining two animals up to the 7-day examination.

VIABILITY/MORTALITY/CLINICAL SIGNS
No clinical signs of systemic toxicity were observed in the animals during the study and no mortality occurred.

BODY WEIGHTS
The body weights of all rabbits were considered to be within the normal range of variability.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The substance is considered to be not irritating to rabbit skin.

Executive summary:

The skin irritation test was performed to rabbit skin according to the OECD Guidelines 404 (1992) and the method B.4 of EEC-Directive 92/69 EEC. 0.5 g of test item were applied (semi-occlusive system) to the intact left flank of 3 young adult New Zealand White rabbits. The duration of treatment was 4 hours.

The test substance was found to be not irritant when applied to intact rabbit skin: local signs (mean values 24/48/72 hours) consisted of grade 0 erythema and grade 0 oedema in all animals. The test item caused a marked violet coloured staining at the test site of all animals 1 hour after removal of the dressing. A light violet staining continued to be observed in one animal up to the 72-hour examination and in the remaining two animals up to the 7-day examination. No corrosive effects were noted on the treated skin of any animal at any of the measuring intervals.