Hexasodium 2,2'-[vinylenebis[(3-sulphonato-4,1-phenylene)imino[6-[(2-cyanoethyl)[2-(2-hydroxyethoxy)ethyl]amino]-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:

August from the 26th to the 30th, 1982

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1982

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 404 (Acute Dermal Irritation / Corrosion)

Version / remarks:

adopted on 12 May, 1981

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Optical Brightener 380

IUPAC Name:

Optical Brightener 380

Test animals

Species:

rabbit

Strain:

New Zealand White

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Kleintierfarm Madoering, AG.
- Age at start of treatment: ca. 12 weeks.
- Body weight at start of treatment: 2.3 - 3 kg.
- Diet: pelleted standard Kliba 23/341/1 rabbit maintenance diet, ad libitum.
- Water: tap water, ad libitum.
- Accomodation: individually in stainless steel cage.
- Acclimation period: 4 days.

ENVIRONMENTAL CONDITIONS
- Temperature: 22 ± 2 °C
- Humidity: 55 ± 10 %
- Photoperiod: 12 hours light/dark.

Test system

Type of coverage:

occlusive

Preparation of test site:

clipped

Vehicle:

other: polyethylene glycol (PEG 400) + saline (70 : 30 parts)

Controls:

yes, concurrent no treatment

Amount / concentration applied:

1 g of a 50 % dilution of the test substance in polyethylene glycol (PEG 400) + saline (70 : 30 parts) was used.

Duration of treatment / exposure:

4 hours

Observation period:

72 hours

Number of animals:

2 males and 1 females

Details on study design:

TEST SITE
- Area of exposure: 24 hours before the treatment, the back and flanks of each rabbit were closely clipped with electric clippers, exposing an area of skin of ca 10 x 10 cm. the test material was applied under a patch of surgical gauze approximately 3.0 x 3.0 cm.
- Type of wrap if used: the patch was covered with impermeable material and fastened to the body with adhesive tape.

OBSERVATION TIME POINTS
The skin reaction of the treated skin site was observed 1 hour, 24, 48, 72 hours, following removal of bandages and gauze patch.

SCORING SYSTEM
Draize 1959; Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States.

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

Oedema formation
No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4

Results and discussion

In vivo

Results

Results 1

Irritation parameter:

erythema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Results 2

Irritation parameter:

edema score

Basis:

animal: 3/3

Time point:

24/48/72 h

Score:

< 2.3

Remarks on result:

no indication of irritation

Irritant / corrosive response data:

Under the conditions of the test, the substance was found to cause no irritation when applied to intact rabbit skin.
In the area of application, no discolouration of the skin was observed in the rabbits which could be related to compound effects.
No corrosion effect had occurred on the skin at each measuring interval.

Any other information on results incl. tables

Animal	Reaction	1 hr	24 htrs	48 hrs	72 hrs
371 M	Erythema	0	0	0	0
372 M	Erythema	0	0	0	0
373 F	Erythema	0	0	0	0
371 M	Oedema	0	0	0	0
372 M	Oedema	0	0	0	0
373 F	Oedema	0	0	0	0

Applicant's summary and conclusion

Interpretation of results:

other: not classified, according to CLP Regulation (EC) No1272/2008

Conclusions:

Not skin irritating

Executive summary:

The skin irritation potential of the test material was investigated by occlusive topical application to three New Zeland White rabbits. 1 g of a 50 % dilution of the test substance in polyethylene glycol (PEG 400) + saline (70 : 30 parts) was used.

The treated skin site was observed 1 hour, 24, 48, 72 hours, following removal of bandages and gauze patch and the skin reactions were scored in accordance with Draize system (1959) and Appraisal of the Safety of Chemical in Foods, Drugs and Cosmetics, Association of Food and Drug Officials of the United States.

Under the conditions of the test, the substance was found to cause no irritation when applied to intact rabbit skin.

In the area of application, no discolouration of the skin was observed in the rabbits which could be related to compound effects.

No corrosion effect had occurred on the skin at each measuring interval.

Conclusion

The mean values from grading at 24, 48 and 72 hours after patch removal were lower than 2.3 in all animals for both erythema/eschar and oedema reactions.