Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1975

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:

1975

Report date:

1975

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO).

Deviations:

yes

Remarks:

Testing under occluvive conditions represents an elevated testing condition and results obtained under such conditions need to be carefully taken ito account for the overall hazard and risk assessment.

Principles of method if other than guideline:

The purpose of this test was to determine the primary-irritation index, which serves as a measure of the acute irritation,provoked by the compound on the skin of the rabbits.

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)

EC Number:

258-027-0

EC Name:

Disodium [3-[(4,5-dihydro-3-methyl-5-oxo-1-phenyl-1H-pyrazol-4-yl)azo]-4-hydroxybenzenesulphonato(3-)][1-[[2-hydroxy-5-(phenylazo)phenyl]azo]-2-naphtholato(2-)]chromate(2-)

Cas Number:

52587-68-5

Molecular formula:

C38H25CrN8O7S.2Na

IUPAC Name:

Disodium [4-(hydroxy-kO)-3-{[5-(hydroxy-kO)-3-methyl-1-phenyl-1H-pyrazol-4-yl]diazenyl-kN1}benzenesulfonato(3-)][1-({2-(hydroxy-kO)-5-[phenyldiazenyl]phenyl}diazenyl-kN1)naphthalen-2-olato(2-)-kO]chromate(2-)

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

None

Specific details on test material used for the study:

Identification: FAT 21095/A
Purity: 80 %

Test animals

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: 1.5 to 2 kgs.
- Housing: In order to prevent injuries by bites the rabbits were kept separately in V2A wire mesh cages.
- Diet and water: they had access to food (NAFAG, Gossau SG, rabbit food) and water ad libitum.

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

other: Polyethylene glycol trituration (PEG 400)

Controls:

no

Amount / concentration applied:

0.5 g

Duration of treatment / exposure:

24 hours

Observation period:

72 hours

Number of animals:

6 rabbits (3 males and 3 females)

Details on study design:

The rabbits were shaved on the whole back and flanks two days before treatment 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.

FAT 21095/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 24 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it, on the basis of the following evaluation scheme.

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
Total possible erythema score: 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
Total possible edema score 4

TEST SITE
- Area of exposure: 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.
- Type of wrap if used: plastic film
- Time after start of exposure: 72 hours

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #1

Time point:

24 h

Score:

0

Max. score:

4

Results 2

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #1

Time point:

48 h

Remarks on result:

not measured/tested

Results 3

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Results 4

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #2

Time point:

24 h

Score:

1

Max. score:

4

Results 5

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #2

Time point:

48 h

Remarks on result:

not measured/tested

Results 6

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Results 7

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #3

Time point:

24 h

Score:

0

Max. score:

4

Results 8

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #3

Time point:

48 h

Remarks on result:

not measured/tested

Results 9

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Results 10

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #4

Time point:

24 h

Score:

1

Max. score:

4

Results 11

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #4

Time point:

48 h

Remarks on result:

not measured/tested

Results 12

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #4

Time point:

72 h

Score:

0

Max. score:

4

Results 13

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #5

Time point:

24 h

Score:

0

Max. score:

4

Results 14

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #5

Time point:

48 h

Remarks on result:

not measured/tested

Results 15

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #5

Time point:

72 h

Score:

0

Max. score:

4

Results 16

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #6

Time point:

24 h

Score:

0

Max. score:

4

Results 17

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #6

Time point:

48 h

Remarks on result:

not measured/tested

Results 18

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #6

Time point:

72 h

Score:

0

Max. score:

4

Results 19

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Time point:

24 h

Score:

0

Max. score:

4

Results 20

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Time point:

48 h

Remarks on result:

not measured/tested

Results 21

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Time point:

72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

Compounds producing combined averages (primary irritation indexes) of 2 or less are only mildly irritating; whereas those with indexes from 2 to 5 are moderate irritants, and those with scores above 6 are considered severe irritants.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The primary irritation index as the measure of the acute irritation to the skin of rabbits was found to be 0.29. Therefore, FAT 21095/A is to be considered as a non-irritant irritant to the skin of rabbits.

Executive summary:

The purpose of this test was to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound on the skin of the rabbits. The procedure adopted was the patch-test technique described in the "Appraisal of the Safety of Chemicals in Foods, Drugs and Cosmetics" (1959) of the US Association of Food and Drug Officials (AFDO). Six rabbits (3 males/3 females) of the Russian breed, were shaved on the whole back and flanks two days before treatment with an electric clipper. The shaven skin on the left side was slightly scarified immediately before treatment. A gauze patch was soaked with the test substance FAT 21095/A (0.5 g) and immediately applied to the prepared skin. The patch was covered with a plastic film (occlusive). FAT 21095/A was applied to each side in quantities of 0.5 g. Before application a 50 % polyethylene glycol trituration (PEG 400) was made. The gauze patches were removed 2 4 hours after the application. The reaction of the skin was appraised upon removal and 72 hours after it. Slight erythema was observed in Intact and abraded skin which was reversible within 72 hours. No edema was observed at any observation time points. The primary irritation index as the measure of the acute irritation to the skin of rabbits was determined to be 0.29. Therefore, FAT 21095/A is to be considered as non-irritant to the skin of rabbits.