Tetrasodium 4,4'-bis[[4-[(2-hydroxyethyl)amino]-6-(m-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Only a summary is available but with enough details available to describe the endpoint.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1970

Report date:

1970

Materials and methods

Principles of method if other than guideline:

The acute dermal LD50 of the test item was tested in rabbits administered by dermal occlusive dressing (Draize method) at a single concentration of 2000 mg/kg bw.

GLP compliance:

no

Remarks:

Pre GLP

Test type:

standard acute method

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium 4,4'-bis[[4-[(2-hydroxyethyl)amino]-6-(m-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate

EC Number:

240-400-4

EC Name:

Tetrasodium 4,4'-bis[[4-[(2-hydroxyethyl)amino]-6-(m-sulphonatoanilino)-1,3,5-triazin-2-yl]amino]stilbene-2,2'-disulphonate

Cas Number:

16324-27-9

Molecular formula:

C36H32N12Na4O14S4

IUPAC Name:

Tetrasodium 2,2'-[(E)-1,2-ethenediyl]bis[5-({4-[(2-hydroxyethyl)amino]-6-[(3-sulfonatophenyl)amino]-1,3,5-triazin-2-yl}amino)benzenesulfonate]

Test animals

Species:

rabbit

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Weight at study initiation: mean 2205 g.
- Housing: one animal per cage.
- Food: Nafag Würfel Nr. 84.

ENVIRONMENTAL CONDITIONS
- Temperature: 23°C ± 2°C
- Humidity: 55 ± 5%
- Photoperiod: 14 hrs light/day.

Administration / exposure

Type of coverage:

occlusive

Vehicle:

other: fresh suspension with gum arabic 1% / tap water

Details on dermal exposure:

APPLICATION
One application to intact skin. Occlusive dressing (Draize method) for 24 hours.

TEST SITE
- Area of exposure: dehairing of the dorsal skin by shearing.
- % coverage: SURFACE OF 200-300 cm2

REMOVAL OF TEST SUBSTANCE
- Washing: washing the application area with lukewarm water and a sponge.

TEST MATERIAL
- Concentration: 80%

Duration of exposure:

24 hours

No. of animals per sex per dose:

3 males and 3 females.

Details on study design:

- Duration of observation period following administration: 8 days.

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No deaths occurred.

Clinical signs:

other: No systemic symptoms were recorded.

Any other information on results incl. tables

Skin reactions recorded

Dose mg/kg	Time point	N. of animals with reactions	Reaction
2000	24 hrs	6/6	Erythema
	2 days	1/6	Erythema, oedema
	3 days	1/6 1/6	Erythema Oedema
	4 days	1/6 1/6	Erythema Scaling, oedema
	5 + 6 days	1/6	Scaling, oedema
	7 + 8 days	2/6 1/6	Scaling Scaling, oedema

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information According to the CLP regulation. Criteria used for interpretation of results: EU

Conclusions:

LD50 > 2000 mg/kg bw

Executive summary:

Method

The acute dermal LD50 of the test item was tested in rabbits administered by dermal occlusive dressing (Draize method) at a single concentration of 2000 mg/kg bw.

Results

No deaths occurred.

LD50 > 2000 mg/kg bw