Trisodium 7-[[4-chloro-6-[(3-sulphonatophenyl)amino]-1,3,5-triazin-2-yl]methylamino]-4-hydroxy-3-[(2-sulphonatophenyl)azo]naphthalene-2-sulphonate

Endpoint summary

Description of key information

Only one study of Acute Toxicity is available. This study meets National standarts method with acceptable restrictions.

Klimish score 2.

Acute Toxicity/Oral LD50=6,16 g/kg

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:

8.-11. 1976

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 1976 . 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: unknown

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: 110-145 g

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

VEHICLE- Concentration in vehicle: 20% w/w

Doses:

7,943 g/kg10,00 g/kg12,59 g/kg15,85 g/kg

No. of animals per sex per dose:

10 animals per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days- Frequency of observations and weighing: no data- Necropsy of survivors performed: yes- Other examinations performed: clinical signs

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

11.66 other: g/kg

Based on:

test mat.

95% CL:

> 10.48 - < 12.98

Mortality:

Number of deaths of each level: 7.943 g/kg: 0 10.00 g/kg: 3 12.59 g/kg: 6 15.85 g/kg: 9

Clinical signs:

clinical signs – diarrhea

Gross pathology:

7.943 g/kg: survived animal – kidneys – colored, in one animal – changes at lung furthermore10.00 g/kg: survived animal – kidneys – colored in 4 animals, changes at lung in 3 animalsdead animals (3) – lung, kidney – congested, spleen – lights, intestine – fulfilled with test substance, organs colored12.59 g/kg: survived animal – kidneys – colored in 3 animals, changes at lung in 1 animalsdead animals (6) – intestine – fulfilled with test substance, organs colored15.85 g/kg: survived animal – kidneys – colored dead animals (9) – intestine – fulfilled with test substance, organs colored, exudate in abdominal cavity

Interpretation of results:

GHS criteria not met

Conclusions:

Based on determined value LD50 = 11,66 g/kg, the tested substance REACTIVE ORANGE 5 has not been classified as acute toxic by the oral route.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

11 660 mg/kg bw