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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

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

Constituent 1
Chemical structure
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