Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

comparable to guideline study with acceptable restrictions

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1978

Report date:

1978

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(no untreated skin areas to serve as the control; amount applied on skin not provided, exposure period is of 24 h; smaller area of application (i.e., approx. 2.5 cm² gauze pad))

Principles of method if other than guideline:

not applicable

GLP compliance:

not specified

Test material

Test material information

Constituent 1

Reference substance name:

Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium

EC Number:

274-386-6

EC Name:

Chromate(2-), [2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-, disodium

Cas Number:

70209-87-9

Molecular formula:

C32H21CrN10Na2O11S

IUPAC Name:

Disodium-[2,4-dihydro-4-[(2-hydroxy-4-nitrophenyl)azo]-5-methyl-2-phenyl-3H-pyrazol-3-onato(2-)][3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-2-hydroxy-5-nitrobenzenesulfonato(3-)]-chromate(2-)

Test material form:

not specified

Details on test material:

- Name of test material (as cited in study report): FAT 20060/B
- Substance type: Dye
- Analytical purity: Approx. 82 %
-Lot/batch No.: EN 78708

Test animals

Species:

rabbit

Strain:

Himalayan

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kg
- Housing: The animals were housed individually in metal cages
- Diet: NAFAG, Gossau SG, rabbit food (ad libitum)
- Water: ad libitum
- Acclimation period: 4 d

ENVIRONMENTAL CONDITIONS
- Temperature: 20±1 °C
- Humidity: 55±5 %
- Photoperiod: 10 h light cycle day

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

not specified

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): No data
- Concentration (if solution): No data

Duration of treatment / exposure:

24 h

Observation period:

24, 48, 72 h, 4 and 7 d

Number of animals:

6 (3 males and 3 females)

Details on study design:

PROCEDURE:
- The test was carried out according to the method given in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO) which is similar to the OECD Guideline 404.
- Before treatment the entire back and the flank of the rabbits were shaved with an electric clipper and immediately before treatment the shaven skin on one side was slightly scarified.
- Gauze patches of 2.5 x 2.5 cm laden with the test substance were applied to the prepared abraded and intact skin.
- The patches were covered with an impermeable material and were fastened to the body of the rabbit with adhesive tape. The dressings were removed after a 24 h exposure. The skin reaction was appraised upon removal during an observation period of 7 d.

SCORING SYSTEM:
Dermal irritation was graded in each animal according to the following scoring scale:
- Erythema and eschar formation:
0 no erythema
1 very slight erythema (barely perceptible)
2 well-defined erythema
3 moderate to severe erythema
4 severe erythema (beet redness) to slight eschar formation (injuries in depth).
 
- Edema formation:
0 no edema
1 very slight edema (barely perceptible)
2 slight edema (edges of area well-defined by definite raising)
3 moderate edema (raised approximately 1 millimeter)
4 severe edema (raised more than 1 millimeter and extending beyond area of exposure).

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

(intact skin)

Basis:

animal #1

Time point:

other: 24, 48, 72 h (mean)

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 2

Irritation parameter:

erythema score

Remarks:

(intact skin)

Basis:

animal #2

Time point:

other: 24, 48, 72 h (mean)

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48

Results 3

Irritation parameter:

erythema score

Remarks:

(intact skin)

Basis:

animal #3

Time point:

other: 24, 48, 72 h (mean)

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 4

Irritation parameter:

erythema score

Remarks:

(intact skin)

Basis:

animal #4

Time point:

other: 24, 48, 72 h (mean)

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 5

Irritation parameter:

erythema score

Remarks:

(intact skin)

Basis:

animal #5

Time point:

other: 24, 48, 72 h (mean)

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 6

Irritation parameter:

erythema score

Remarks:

(intact skin)

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 7

Irritation parameter:

edema score

Remarks:

(intact skin)

Basis:

animal #1

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 8

Irritation parameter:

edema score

Remarks:

(intact skin)

Basis:

animal #2

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Results 9

Irritation parameter:

edema score

Remarks:

(intact skin)

Basis:

animal #3

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 10

Irritation parameter:

edema score

Remarks:

(intact skin)

Basis:

animal #4

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 11

Irritation parameter:

edema score

Remarks:

(intact skin)

Basis:

animal #5

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Results 12

Irritation parameter:

edema score

Remarks:

(intact skin)

Basis:

animal #6

Time point:

24/48/72 h

Score:

0.33

Max. score:

4

Reversibility:

fully reversible within: 48 h

Irritant / corrosive response data:

Test substance was found to cause a slight irritation when applied to intact and abraded rabbit skin.
The calculated primary irritation index was 1.7.

Other effects:

none

Any other information on results incl. tables

Calculation of the primary skin irritation index:

Mean reaction score of 6 rabbits
Time after exposure (h)	erythema		edema
	intact skin	abraded skin	intact skin	abraded skin
24	0.3	2.3	0.3	2.3
72	0	0.83	0	0.83
Total	0.3	3.13	0.3	3.13	6.86

Primary irritation index = 6.86 : 4 = 1.7

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance is considered to be not irritating to the skin.

Executive summary:

An in vivo study was conducted to evaluate the skin irritation potential of the test substance (at ca. 82 % purity) in Himalayan rabbits according to the method given in the Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO), which is similar to OECD Guideline 404 with few deviations. The test substance was placed on a 2.5 cm² gauze pad which was then applied to abraded as well as intact skin of rabbits for 24 h under occlusive conditions. After the application period, the dressing was removed and the intact and abraded sites were assessed for oedema and erythema. A further assessment was made at 48, 72 h, 4 and 7 d. Very slight erythema as well as edema were observed in two rabbits at 24 h. These symptoms were fully reversible within 48 h. The primary irritation index was calculated to be 1.7. Under the study conditions, the test substance was considered to cause slight irritation which was fully reversible within 48 h when applied to intact and abraded rabbit skin. However, it does not meet the threshold criteria for classification for skin irritation as required by the Regulation (EC) No. 1272/2008 (CLP), hence considered to be not irritating to the skin.