Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(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:

1973

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:

1973

Report date:

1973

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: test technique as 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:

not specified

Principles of method if other than guideline:

None

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)

EC Number:

257-827-7

EC Name:

Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)

Cas Number:

52301-70-9

Molecular formula:

C40H40N12O20S6.6Na

IUPAC Name:

hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-morpholino-1,3,5-triazine-4,2-diyl]imino]]bis(benzene-1,4-disulphonate)

Test animals

Species:

rabbit

Strain:

other: Russian breed

Details on test animals or test system and environmental conditions:

TEST ANIMALS

- Housing: single metal cages
- Diet (e.g. ad libitum): Nafag ad libitum
- Water (e.g. ad libitum): Drinking water ad libitum
- Acclimation period: 8 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18+/-1 °C
- Humidity (%): 55+/-5 %
- Photoperiod (hrs dark / hrs light): 14 hours light/day

Test system

Type of coverage:

occlusive

Preparation of test site:

shaved

Vehicle:

not specified

Controls:

no

Amount / concentration applied:

The substance was applied to each side in quantities of 0.5 ml.

Duration of treatment / exposure:

24 h

Observation period:

The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 9 days.

Number of animals:

6 (3 Males and 3 Females)

Details on study design:

6 rabbits ( 3 males; 3 females) of the Russian breed, weighing 1.4 to 1.7 kg, were shaved one day before treatment with an electric clipper on the flanks. The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediately to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape. The substance was applied to each side in quantities of 0.5 ml . The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 9 days.

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

mean

Time point:

24/48/72 h

Score:

0.1

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: with intact skin

Results 2

Irritation parameter:

edema score

Basis:

mean

Time point:

24/48/72 h

Score:

0

Max. score:

4

Reversibility:

fully reversible

Remarks on result:

other: with intact skin

Irritant / corrosive response data:

None

Other effects:

None

Any other information on results incl. tables

Scores for erythema

Erythema with intact skin
Animal	Observation time
	24 hours		48 hours	72 hours
1	0		0	0
2	0		0	0
3	0		0	0
4	1		0	0
5	0		0	0
6	1		0	0
Mean	0.33		0	0

Erythema with abraded skin
Animal	Observation time
	24 hours		48 hours	72 hours
1	1		1	0
2	1		1	0
3	1		0	0
4	1		0	0
5	1		1	1
6	1		0	0
Mean	1.00		0.50	0.17

Scores for oedema

Oedema with intact skin
Animal	Observation time
	24 hours		48 hours	72 hours
1	0		0	0
2	0		0	0
3	0		0	0
4	0		0	0
5	0		0	0
6	0		0	0
Mean	0		0	0

Oedema with abraded skin
Animal	Observation time
	24 hours		48 hours	72 hours
1	0		0	0
2	0		0	0
3	0		0	0
4	0		0	0
5	0		0	0
6	0		0	0
Mean	0		0	0

Applicant's summary and conclusion

Interpretation of results:

other: Not classified as irritant according to the CLP Regulation (EC) No.1272/2008

Conclusions:

The substance was found to cause a slight erythema without oedema with the intact skin. Hence, it does not warrant classification as per the Regulation EC No. 1272/2008.

Executive summary:

The skin irritation potential of the test item was evalauted in a study conducted according to the patch test technique as 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). The test item was applied to each side of the shaved flank region of 6 Russian breed rabbits in quantities of 0.5 ml . The shaved skin area on the left side was slightly scarified just before treatment. A gauze patch of 2.5 x 2.5 cm laden with test substance was applied immediatly to the prepared skin. The patch was covered with an impermeable foil of 5x5 cm, which was fixed to the body of the animals with adhesive tape. The gauze patches were removed 24 hours after application. The reaction of the skin was appraised upon removal during an observation period of 9 days. A slight erythema without oedema was observed with the intact skin. Hence, the test item does not warrant classification as per the Regulation EC No. 1272/2008.