Tetrasodium [3-[(3-chloro-2-hydroxy-5-sulphophenyl)azo]-5-[[4-chloro-6-(3-sulphoanilino)-1,3,5-triazin-2-yl]amino]-4-hydroxynaphthalene-2,7-disulphonato(6-)]cuprate(4-)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1991

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: meets generally accepted scientific standards and acceptable for assessment

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1991

Report date:

1991

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

The study report contains the limited information on the test conditions because the study has been performed in 1991. However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.

GLP compliance:

not specified

Test type:

fixed dose procedure

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium [3-[(3-chloro-2-hydroxy-5-sulphophenyl)azo]-5-[[4-chloro-6-(3-sulphoanilino)-1,3,5-triazin-2-yl]amino]-4-hydroxynaphthalene-2,7-disulphonato(6-)]cuprate(4-)

EC Number:

274-977-9

EC Name:

Tetrasodium [3-[(3-chloro-2-hydroxy-5-sulphophenyl)azo]-5-[[4-chloro-6-(3-sulphoanilino)-1,3,5-triazin-2-yl]amino]-4-hydroxynaphthalene-2,7-disulphonato(6-)]cuprate(4-)

Cas Number:

70880-03-4

Molecular formula:

C25H11Cl2CuN7O14S4.4Na

IUPAC Name:

tetrasodium [3-[(3-chloro-2-hydroxy-5-sulphophenyl)azo]-5-[[4-chloro-6-(3-sulphoanilino)-1,3,5-triazin-2-yl]amino]-4-hydroxynaphthalene-2,7-disulphonato(6-)]cuprate(4-)

Test material form:

solid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Weight at study initiation: 260 - 278 g

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE- Area of exposure: 4×6 cm- coverage: 100 %- Type of wrap if used: mull, aluminum foil, and plaster bandageREMOVAL OF TEST SUBSTANCE- Time after start of exposure: 24 hTEST MATERIAL- Amount(s) applied (volume or weight with unit):- Concentration (if solution):- Constant volume or concentration used: yes/no- For solids, paste formed: yes/noVEHICLE- Amount(s) applied (volume or weight with unit):- Concentration (if solution):- Lot/batch no. (if required):- Purity:

Duration of exposure:

treatment: 24 hafter treatment observation period: 14 d

Doses:

5 g/kg

No. of animals per sex per dose:

5 animals

Control animals:

not specified

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Clinical signs:

no clinical sights of intoxication

Body weight:

standard body weight gain

Gross pathology:

without macroscopic morphological changes

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

The test substance, Reactive Violet 1, is not absorbed through the skin in a toxic quantity.