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-)

Endpoint summary

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1978

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: meets generally accepted scientific standards and acceptable for assessment

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 1979. 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:

no

Test type:

other: unknonwn

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Weight at study initiation: 110 - 150 g

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

VEHICLE- Concentration in vehicle: 20 % w/w

Doses:

5,020 g/kg6.310 g/kg7.943 g/kg10.00 g/kg

No. of animals per sex per dose:

10 animals per dose

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days- Necropsy of survivors performed: yes- Other examinations performed: clinical signs (diarrhea)

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

5 916 mg/kg bw

Based on:

test mat.

95% CL:

5 356 - 6 535

Mortality:

5.020 g/kg - 1/106.310 g/kg - 8/107.943 g/kg - 9/1010.00 g/kg - 10/10

Clinical signs:

diarrhea, vomiting

Gross pathology:

5.020 g/kg:dead animal (1)– stomach, intestine – dilatation, filled with the test substance, muscles +organs – coloredsurvived animals – lymph nodes + kidney – colored6.310 g/kg:dead animals (8) – stomach, intestine – dilatation, filled with the test substance, muscles +organs – coloredsurvived animals – lymph nodes, kidney, muscles, cartilages –strongly colored7.943 g/kg:dead animals (9)– stomach, intestine – dilatation, filled with the test substance, muscles +organs – coloredsurvived animal – stomach mucosa, kidney, muscles, lymph nodes –strongly colored10.00 g/kg:dead animals (10) – stomach, intestine – dilatation, filled with the test substance, muscles +organs – strongly colored

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Based on determined value LD50 = 5.916 g/kg, the tested substance, Reactive Violet 1, has not been classified as acute toxic by the oral route.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

5 916 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

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

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

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Justification for classification or non-classification

According to results of acute toxicity tests, the test substance, Reactive Violet 1, cannot be classified as acute toxic.