Trisodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonatonaphthyl]azo]-2,5-dimethylphenyl]azo]benzene-1,4-disulphonate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1974

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:

1974

Report date:

1974

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: U.S.A. Federal Hazardous Substances Labelling Act Sect. 191.11 (February 1965)

Deviations:

not specified

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Deviations:

yes

Remarks:

(48 h observation not done; involved a 24 h test substance exposure followed by observations at 24 and 72 h; test substance was patched both on abraded and on intact skin of six animals; local and systemic adverse effects not described)

GLP compliance:

no

Remarks:

Pre-GLP study

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonatonaphthyl]azo]-2,5-dimethylphenyl]azo]benzene-1,4-disulphonate

EC Number:

274-410-5

EC Name:

Trisodium 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulphonatonaphthyl]azo]-2,5-dimethylphenyl]azo]benzene-1,4-disulphonate

Cas Number:

70210-13-8

Molecular formula:

C27H22ClN9O9S3.3Na

IUPAC Name:

trisodium 2-{[4-({4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfonato-1-naphthyl}diazenyl)-2,5-dimethylphenyl]diazenyl}benzene-1,4-disulfonate

Test material form:

solid: particulate/powder

Remarks:

migrated information: powder

Specific details on test material used for the study:

Name: FAT 40075/A
Purity: 74.5 %

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Bred on the premises of the testing laboratory
- Age at study initiation: 3 to 4 months
- Weight at study initiation: Males: 2.33 kg; Females: 2.06 kg
- Housing: Caged singly
- Diet: A commercial irradiated diet (Styles-Oxoid), ad libitum
- Water: Sterile filtered water, ad libitum
- Acclimation period: 1 week

ENVIRONMENTAL CONDITIONS
- Temperature: 20 ± 1 °C
- Humidity: 50-70 %
- Photoperiod: Animals were exposed to artificial light for 10 h daily from 08:00 - 18:00 h

Test system

Type of coverage:

occlusive

Preparation of test site:

other: both abraded and intact skin areas lateral to the midline of the back

Vehicle:

water

Controls:

not specified

Amount / concentration applied:

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL (i.e., 500 mg)
- Concentration (if solution): 66.66 %

Duration of treatment / exposure:

24 h

Observation period:

Up to 72 h (The skin reactions were assessed at 24 and 72 h)

Number of animals:

six animals (four males and two females)

Details on study design:

TEST SITE
- 24 h prior to the dermal application, the backs of the animals were shaved over an area consisting of at least 10% of the total body surface. Two test sites lateral to the mid line of the back were used on each animal. Immediately before the application of the test compound, the right hand site was abraded with the point of a sterile hypodermic needle. The abrasions were sufficiently deep to penetrate the stratum corneum but not to damage the dermis. The left hand site remained intact.
- The test substance was applied to each test site on a 2.5 cm² gauze pad. These were covered with aluminium foil secured with "Sleek" adhesive tape. The test sites were then enclosed by a 6 inch wide "Coban" self adhesive bandage, the edges of which were fixed to the skin by strips of "Sleek" in order to retain the test substance in close contact with the skin.

SCORING SYSTEM: Draize scoring system

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Remarks:

Intact skin

Basis:

animal #1

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

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

Reversibility:

fully reversible within: 72 h

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:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

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:

0

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:

1

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:

1

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:

animal #1

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 20

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #1

Time point:

48 h

Remarks on result:

not measured/tested

Results 21

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #1

Time point:

72 h

Score:

0

Max. score:

4

Results 22

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #2

Time point:

24 h

Score:

4

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 23

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #2

Time point:

48 h

Remarks on result:

not measured/tested

Results 24

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #2

Time point:

72 h

Score:

0

Max. score:

4

Results 25

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #3

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 26

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #3

Time point:

48 h

Remarks on result:

not measured/tested

Results 27

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #3

Time point:

72 h

Score:

0

Max. score:

4

Results 28

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #4

Time point:

24 h

Score:

1

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 29

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #4

Time point:

48 h

Remarks on result:

not measured/tested

Results 30

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #4

Time point:

72 h

Score:

0

Max. score:

4

Results 31

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #5

Time point:

24 h

Score:

2

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 32

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #5

Time point:

48 h

Remarks on result:

not measured/tested

Results 33

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #5

Time point:

72 h

Score:

0

Max. score:

4

Results 34

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #6

Time point:

24 h

Score:

3

Max. score:

4

Reversibility:

fully reversible within: 72 h

Results 35

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #6

Time point:

48 h

Remarks on result:

not measured/tested

Results 36

Irritation parameter:

edema score

Remarks:

Intact skin

Basis:

animal #6

Time point:

72 h

Score:

0

Max. score:

4

Irritant / corrosive response data:

A slight erythema and a slight to severe oedema was seen in all animals involving both intact and abraded sites 24 h after application of the test substance. By 72 h a slight to mild oedema was seen in the abraded sites of 3/6 animals.

Any other information on results incl. tables

Table:

Erythema Formation					Total
Intact			Abraded
Animal no./sex	24 h	72 h	24 h	72 h
1 (Male)	1	0	1	0
2 (Male)	1	0	1	0
3 (Male)	1	0	1	0
4 (Female)	0	0	1	0
5 (Female)	1	0	1	0
6 (Female)	1	0	1	0
Mean	0.83	0.00	1.00	0.00	1.83

Oedema Formation					Total
Intact			Abraded
No. animal	24 h	72 h	24 h	72 h
1 (Male)	2	0	2	0
2 (Male)	4	0	4	2
3 (Male)	3	0	3	0
4 (Female)	1	0	2	2
5 (Female)	2	0	2	0
6 (Female)	3	0	3	1
Mean	2.50	0.00	2.67	0.83	6.00
				Erythema + Oedema	7.83

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

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

Executive summary:

An in vivo study was conducted to evaluate the skin irritation potential of the test substance (at ca. 74.5 % purity) in rabbits according to the US-FHSA Sect. 191.11 (February 1965) method which is similar to OECD Guideline 404 with few deviations. The test substance was applied under two patches (each on an intact and an abraded site) on the backs of six animals (3/sex). Each test site received 0.75 mL (i.e. 500 mg) of 66.66 % solution in water on a 2.5 cm² gauze pad for 24 h under occlusive conditions. Resulting skin lesions were assessed for erythema and oedema at 24 and 72 h after patch removal. Slight erythema and slight to severe oedema was seen in all animals involving both intact and abraded sites 24 h after application of the test substance. By 72 h, a slight to mild oedema was seen in the abraded sites of 3/6 animals. Skin reactions of intact test sites (by 72 h) returned to normal earlier than abraded. Under the study conditions, the test substance was considered to be non-irritating to skin.