Cobaltate(3-), bis[4-[4-[[4-[4-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

weight of evidence

Study period:

September/October, 1980

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1980

Report date:

1980

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: ETAD method 002

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Cobaltate(3-), bis[4-[4-[[4-[4-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium

EC Number:

278-140-9

EC Name:

Cobaltate(3-), bis[4-[4-[[4-[4-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium

Cas Number:

75214-72-1

Molecular formula:

C52H40CoN18Na3O16S4

IUPAC Name:

Cobaltate(3-), bis[4-[4-[[4-[4-[[5-(aminosulfonyl)-2-hydroxyphenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]phenyl]azo]-4,5-dihydro-3-methyl-5-oxo-1H-pyrazol-1-yl]benzenesulfonato(3-)]-, trisodium

Test material form:

solid: particulate/powder

Test animals

Species:

rabbit

Strain:

other: albino

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Remarks:

abraded and intact skin

Vehicle:

water

Remarks:

distilled

Controls:

no

Amount / concentration applied:

0.5 g of the test item moistened with 0.5 ml of distilled water

Duration of treatment / exposure:

24 h

Observation period:

72 h

Number of animals:

6 (3 males and 3 females)

Details on study design:

Primary irritation to the skin was measured by a patch test technique on the abraded and intact skin of the rabbit. A square patch such as surgical gauze measuring 1 inch * 1 inch with two single layers thick was used. The animals were immobilized with patches secured in place by adhesive tape. The entire trunk of the animal is then wrapped with an impervious material such as rubberized cloth. After the exposure period the patches were removed and the resulting reactions are evaluated on the basis of the scoring system.

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

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: #1, #3, #4, #5, #6

Time point:

24/48/72 h

Score:

0

Remarks on result:

other:

Remarks:

abraded and intact skin

Results 2

Irritation parameter:

edema score

Basis:

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

Time point:

24/48/72 h

Score:

0

Remarks on result:

other:

Remarks:

abraded and intact skin

Results 3

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

other:

Remarks:

abraded skin

Results 4

Irritation parameter:

erythema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

not specified

Remarks on result:

other:

Remarks:

intact skin

Results 5

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

0

Remarks on result:

other:

Remarks:

abraded skin

Results 6

Irritation parameter:

edema score

Basis:

animal #2

Time point:

24/48/72 h

Score:

1.67

Max. score:

2

Reversibility:

not specified

Remarks on result:

other:

Remarks:

intact skin

Irritant / corrosive response data:

Very slight erythema and oedema were observed at the intact site of one animal at the 24 hours reading. Well defined erythema accompanied by slight oedema had developed at this site by the 72 hours observation.
Five animals did not show any observable response to treatment throughout the 72 hours observation period.

Any other information on results incl. tables

As the observations time were only at 24 and 72 h, for mean calculations of 24/48/72 h it was used the worst case approach using the higher score at 48 h.

Applicant's summary and conclusion

Interpretation of results:

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

Conclusions:

The test item was found to be not irritating when applied to intact and abraded rabbit skin

Executive summary:

The skin irritation potential of the test item was evaluated in an in vivo skin irritation test performed using the intact and abraded skin of six rabbits, according to the ETAD Method No. 002.

Erythema and oedema scores were found to be 0 in five of the animals, both on the intact and abraded skin sites. Only one animal (#2) shown signs of erythema and oedema (grade 1 for both erythema and oedema at 24 hours and grade 2 for erythema and oedema at 72 hours), and these signs were only present on the intact skin. These data should be considered ambiguous due to the fact that no erythema or oedema was observed on the abraded skin site of the same animal at the same time intervals. Moreover, the uncertainty of these data can be confirmed considering that no effects were observed in all the other animals.