Reaction mass of Cobaltate(2-), [2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)][2-[[2-hydroxy-5-[(phenylamino)sulfonyl]phenyl]azo]-3-oxo-N-phenylbutanamidato(2-)]-, disodium and Cobaltate(3-), bis[2-[[[4-hydroxy-3-[[2-oxo-1-[(phenylamino)carbonyl]propyl]azo]phenyl]sulfonyl]amino]benzoato(3-)]-, trisodium and sodium bis[2-[[2-hydroxy-5-[(phenylamino)sulphonyl]phenyl]azo]-3-oxo-N-phenylbutyramidato(2-)]cobaltate(1-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

November from the 01st to the 08th, 1985

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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

May 12, 1981

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Acid Yellow 235

IUPAC Name:

Acid Yellow 235

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoerin AG, CH 4414 Fuellinsdorf / Switzerland.
- Age at study initiation: 15 - 16 weeks.
- Weight at study initiation: 2.4 - 3.4 kg
- Housing: individually in stainless cages equipped with an automatic cleaning and drinking system.
- Diet: pelleted standard Kliba 341, Batch 10/85 rabbit maintenance diet ("KIiba" Klingentalmuehle AG, Switzerland), ad Iibitum.
- Water: community tap water from Itigen, ad libitum.
- Acclimation period: four days under test conditions after veterinary examination.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Relative humidity: 55 ± 10 %
- Air changes: 10-15 air changes per hour.
- Photoperiod: 12 hrs dark / 12 hrs artificial fluorescent Iight.
- Other: music/light period.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

TEST MATERIAL
- Amount applied: 0.5 g

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

2 maels and 1 female

Details on study design:

TEST SITE
- Area of exposure: approximately 24 hours before treatment, the dorsal fur was shaved with an electric clipper, exposing an area of approximately 100 square centimeters (10 cm x 10 cm). It was covered with a 3 0 cm x 3.0 cm patch of surgical gauze.
- Type of wrap if used: t he gauze was covered with aluminium foil and then covered with an occlusive-dressing. The dressing was wrapped around the abdomen and anchored with an elastic bandage.

OBSERIVATIONS
- Viability / mortality: daily.
- Bodyweights: Day 1 and at termination of test on a Mattler PK 16 balance.

OBSERVATION TIME POINTS
For each individual animal, the irritation scores for erythema and edema were recorded at 60 minutes, 24, 48 and 72 hours after patch removal; in addition, any lesions, a description of the degree and nature of irritation, corrosion or reversibility and any toxic effect observed were recorded.

SCORING SYSTEM
Four hours after the application, the dressing was removed and the skin was flushed with luke warm tap water. The skin reaction was assessed according to the OECD guideline 404. The skin reaction was assessed at 1-, 24-, 48 and 72 hours intervals after the removal of the dressing, gauze patch and test articIe.
The corrosive properties of the test article and the colour to the treated skin area were described and recorded.

Erythema and Eschar Formation
No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to slight eschar formation (injuries in depth) 4

Oedema Formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (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: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Under the conditions of the experiment, the test item was found to cause a primary irritation score of 0 when applied to intact rabbit skin. In the area of application a clear visible yellowish-brown discoloration of the skin was observed which could be related to effects of the test article.
No destructions or irreversible alterations effect had occurred on the skin at each measuring interval.

Other effects:

BODY WEIGHTS
The body weight gain of all rabbits was similar.

TOXIC SYMPTOMS / MORTALITY
No acute toxic symptoms were observed in the animals during the test period and no mortality occurred.

Any other information on results incl. tables

Animal N. / sex	Reaction	Observation at
		1 hr	24 hrs	48 hrs	72 hrs
298 M	Erythema	0	0	0	0
299 M	Erythema	0	0	0	0
300 F	Erythema	0	0	0	0
298 M	Oedema	0	0	0	0
299 M	Oedema	0	0	0	0
300 F	Oedema	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to the CLP Regulation (EC) No 1272/2008

Conclusions:

Not irritating

Executive summary:

The purpose of the primary skin irritation study was to assess possible irritation potential when single doses of test item are placed on the skin of rabbits. The experiment was conducted in accordance with the method and procedures outlined into the OECD guideline 404.

Under the conditions of the experiment, the test item was found to cause a primary irritation score of 0 when applied to intact rabbit skin. In the area of application a clear visible yellowish-brown discoloration of the skin was observed which could be related to effects of the test article.

No corrosion effect had occurred on the skin at each measuring interval.

Conclusion

Mean values from gradings at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions, thus the test item does not meet the criteria to be classified as irritating, according to the CLP Regulation (EC) No 1272/2008.