Trisodium 5-[[4-chloro-6-(ethylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

July 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

Refer chapter 13 for the detailed analogue justification.

Cross-reference

Reason / purpose for cross-reference:

reference to same study

Reference

Endpoint:

skin irritation: in vivo

Type of information:

read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

key study

Study period:

July 1974

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with national standard methods with acceptable restrictions

Justification for type of information:

Refer chapter 13 for the detailed analogue justification.

Reason / purpose for cross-reference:

read-across source

GLP compliance:

no

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

males and females

Time point:

other: 24 and 72 h

Score:

0.8

Max. score:

8

Reversibility:

fully reversible within: 72 h

Remarks on result:

other:

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

mean

Remarks:

6 rabbits

Time point:

24 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

mean

Remarks:

6 rabbits

Time point:

24 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

erythema score

Remarks:

Intact and abraded skin

Basis:

mean

Remarks:

6 rabbits

Time point:

48 h

Remarks on result:

not measured/tested

Irritation parameter:

erythema score

Remarks:

Intact and abraded skin

Basis:

mean

Remarks:

6 rabbits

Time point:

72 h

Score:

0

Max. score:

4

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Remarks:

6 rabbits

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

edema score

Remarks:

Abraded skin

Basis:

mean

Remarks:

6 rabbits

Time point:

24 h

Score:

1.17

Max. score:

4

Reversibility:

fully reversible within: 72 h

Irritation parameter:

edema score

Remarks:

Intact and abraded skin

Basis:

mean

Remarks:

6 rabbits

Time point:

48 h

Remarks on result:

not measured/tested

Irritation parameter:

edema score

Remarks:

Intact and abraded skin

Basis:

mean

Remarks:

6 rabbits

Time point:

72 h

Score:

0

Max. score:

4

Interpretation of results:

GHS criteria not met

Conclusions:

Based on the read across data generated from the skin irritation study of Reactive Red 024, the target substance (Reactive Red 024:1) is also considered to be as non-irritant to the skin of rabbits.

Executive summary:

Data on skin irritation study was not available for the target substance (Reactive Red 024:1). To fill the data gaps, read across approach is adapted using similar substance Reactive Red 024. A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 40034, on the skin of the rabbits according to the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). 6 rabbits (3 males and 3 females), New Zealand White 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 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. 10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml. 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad. The gauze patches were removed 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it. The primary irritation index was calculated as 0.8. The effects were observed to be completely reversible by the end of 72 h.

Therefore, based on the read across data generated from the skin irritation study of Reactive Red 024, the target substance (Reactive Red 024:1) is also considered to be as non-irritant to the skin of rabbits.

 

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1974

Report date:

1974

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965).

Deviations:

not specified

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

EC Number:

274-417-3

EC Name:

Trisodium 5-[[4-chloro-6-(methylphenylamino)-1,3,5-triazin-2-yl]amino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2,7-disulphonate

Cas Number:

70210-20-7

Molecular formula:

C26H20ClN7O10S3.3Na

IUPAC Name:

trisodium 5-({4-chloro-6-[methyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(2-sulfonatophenyl)diazenyl]naphthalene-2,7-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Details on test material:

FAT 40034/B

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Inhouse breeding
- Age at study initiation: 3 - 4 months
- Weight at study initiation: 2.65 Kgs. (male) and 2.53 Kgs.(female)
- Housing: caged singly
- Diet:commercial irradiated diet (Styles-Oxoid) ad libitum
- Water: Sterile filtered water ad libitum
- Acclimation period: One week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 1
- Humidity (%): 50 - 70
- Photoperiod (hrs dark / hrs light): 10 h light

Test system

Type of coverage:

semiocclusive

Preparation of test site:

shaved

Vehicle:

water

Controls:

yes, concurrent no treatment

Amount / concentration applied:

10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml. 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad.

Duration of treatment / exposure:

24 h

Observation period:

After 24 h 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.

Number of animals:

3 males and 3 females

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

primary dermal irritation index (PDII)

Basis:

mean

Remarks:

males and females

Time point:

other: 24 and 72 h

Score:

0.8

Max. score:

8

Reversibility:

fully reversible within: 72 h

Remarks on result:

other:

Results 2

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

mean

Remarks:

6 rabbits

Time point:

24 h

Score:

0.5

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 3

Irritation parameter:

erythema score

Remarks:

abraded skin

Basis:

mean

Remarks:

6 rabbits

Time point:

24 h

Score:

0.67

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 4

Irritation parameter:

erythema score

Remarks:

Intact and abraded skin

Basis:

mean

Remarks:

6 rabbits

Time point:

48 h

Remarks on result:

not measured/tested

Results 5

Irritation parameter:

erythema score

Remarks:

Intact and abraded skin

Basis:

mean

Remarks:

6 rabbits

Time point:

72 h

Score:

0

Max. score:

4

Results 6

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

mean

Remarks:

6 rabbits

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 7

Irritation parameter:

edema score

Remarks:

Abraded skin

Basis:

mean

Remarks:

6 rabbits

Time point:

24 h

Score:

1.17

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 8

Irritation parameter:

edema score

Remarks:

Intact and abraded skin

Basis:

mean

Remarks:

6 rabbits

Time point:

48 h

Remarks on result:

not measured/tested

Results 9

Irritation parameter:

edema score

Remarks:

Intact and abraded skin

Basis:

mean

Remarks:

6 rabbits

Time point:

72 h

Score:

0

Max. score:

4

Any other information on results incl. tables

Individual Animal Score:

 

Erythema Score

Animal Number	Intact skin		Abraded skin
	24 h	72 h	24 h	72 h
11	1	0	1	0
13	0	0	0	0
15	1	0	1	0
12	1	0	1	0
14	0	0	0	0
16	0	0	1	0
Mean	0.50	00	0.67	00

 

Edema Score

Animal Number	Intact skin		Abraded skin
	24 h	72 h	24 h	72 h
11	0	0	1	0
13	0	0	1	0
15	2	0	2	0
12	2	0	1	0
14	0	0	1	0
16	2	0	1	0
Mean	1.00	00	1.17	00

 

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

FAT 40034/A is to be considered as non-irritant to the skin of rabbits.

Executive summary:

A study was performed to determine the primary-irritation index, which serves as a measure of the acute irritation, provoked by the compound, FAT 40034, on the skin of the rabbits according to the "Hazardous Substances Regulations" under the U.S. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965). 6 rabbits (3 males and 3 females), New Zealand White 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 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. 10 g of the test compound was mixed with 10 ml of water to make a solution of 15 ml. 0.75 ml of which was applied to each test site on a 2.5 cm square gauze pad. The gauze patches were removed 24 h after the application. The reaction of the skin was appraised upon removal and 72 h after it. The primary irritation index was calculated as 0.8. The effects were observed to be completely reversible by the end of 72 h. Therefore, FAT 40034/A is to be considered as a non-irritant to the skin of rabbits.