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

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

Justification for type of information:

see document in section 13

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1975

Report date:

1975

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; 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

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:

C32H21CrN10O11S.2Na

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 animals

Species:

rabbit

Strain:

other: Russian

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 V2A wire cages.
- Diet: Standard rabbit food - NAFAG, Gossau SG, rabbit food (ad libitum)
- Water: ad libitum

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: polyethylene glycol (PEG 400)

Controls:

not specified

Amount / concentration applied:

- Amount(s) applied (volume or weight with unit): 500 mg
- Concentration (if solution): 50 %

Duration of treatment / exposure:

24 h

Observation period:

24 and 72 h

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.
-2 d prior to the dermal application, six rabbits were shaved on the whole back and flanks with an electric clipper.
-The shaven skin on the left side was slightly scarified immediately before treatment.
-A gauze patch 2.5 x 2.5 cm was soaked with the test substance and immediately applied to the prepared skin. The patch was covered with a plastic film 5 x 5 cm, which was fixed to the body with adhesive tape
-Test substance was applied to each side in quantities of 500 mg. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it.

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

Basis:

other: all animals

Time point:

other: 24, 72 h mean

Score:

0

Max. score:

4

Remarks on result:

other: for both intact and abraded skin

Results 2

Irritation parameter:

edema score

Basis:

other: all animals

Time point:

other: 24, 72 h mean

Score:

0

Max. score:

4

Remarks on result:

other: for both intact and abraded skin

Results 3

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Time point:

other: all the ratings found after 24 and 72 h

Score:

0

Remarks on result:

other: for both intact and abraded skin

Irritant / corrosive response data:

The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.

Other effects:

none

Any other information on results incl. tables

Evaluation of the skin reactions:

Animal No. (sex)	Skin Reaction	24 h after application		72 h after application
		Intact skin	Scarified skin	Intact skin	Scarified skin
1 (M)	Erythema	0	0	0	0
	Edema	0	0	0	0
2 (M)	Erythema	0	0	0	0
	Edema	0	0	0	0
3 (M)	Erythema	0	0	0	0
	Edema	0	0	0	0
4 (F)	Erythema	0	0	0	0
	Edema	0	0	0	0
5 (F)	Erythema	0	0	0	0
	Edema	0	0	0	0
6 (F)	Erythema	0	0	0	0
	Edema	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

not classified

Conclusions:

Under the study conditions, the test substance was considered to be non-irritating to rabbit skin.

Executive summary:

An in vivo study was conducted to evaluate the skin irritation potential of the analogue substance 2 (at ca. 75% purity) in Russian 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.

 

In this study, 500 mg of test substance (i.e. 50% polyethylene glycol trituration (PEG 400)) was applied on a 2.5 cm2 gauze pad which was then applied to the abraded as well as intact skin of rabbits for 24 h under occlusive conditions. After the 24 h of application period, the dressing was removed and the intact and abraded application sites were assessed for oedema and erythema. A further assessment was made at 72 h.

 

No skin reaction was observed in any of the treated animal. The primary irritation index was calculated to be 0.

 

Under the study conditions, the analogue substance 2 was considered to be non-irritating to rabbit skin.