Tetrasodium 2-[[4-[[4-[[1-hydroxy-6-(phenylamino)-3-sulphonato-2-naphthyl]azo]-1-naphthyl]azo]-6-sulphonato-1-naphthyl]azo]benzene-1,4-disulphonate

Endpoint summary

Description of key information

Acute Toxicity- Oral point

Only one study is available. Klimish score 2.

LD50=9.822 g/kg (for male)

Acute Toxicity - Dermal point

Only one study is available. Klimish score 2.

LD50 > 5 g/kg/bw (for male)

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:

7.-11.1977

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 1977. 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:

9.822 other: g/kg

Based on:

test mat.

95% CL:

> 8.462 - < 11.4

Mortality:

Number of deaths of each level: 7.943 g/kg: 2:10 10.00 g/kg: 7:10 12.59 g/kg: 6:10 15.85 g/kg: 10:10

Clinical signs:

other: clinical signs – diarrhea

Interpretation of results:

GHS criteria not met

Conclusions:

Based on determined value LD50 = 9,822 g/kg, the tested substance Direct Blue 78 has not been classified as acute toxic by the oral route.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

9 822 mg/kg bw

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:

02.-03.1991

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:

no

Test type:

fixed dose procedure

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMAL- Number of animals: 5- Weight at study initiation: 264-294 g- Housing: 1 animal per cage

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE - Area of exposure: 4x6 cm, depilated skin - Type of wrap if used: mull, aluminium fall, plaster bandage REMOVAL OF TEST SUBSTANCE - Time after start of exposure: 24h TEST MATERIAL - Amount(s) applied: 5g/kg - For solids, paste formed: yes (substance+ 1,5 ml water)

Duration of exposure:

24h

Doses:

5.0 g/kg

No. of animals per sex per dose:

5 animals

Control animals:

not specified

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of observations and weighing: after 14 days - Necropsy of survivors performed: yes - Other examinations performed: clinical observation of animals was practised every day,

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

> 5 other: g/kg

Mortality:

no mortality during test

Clinical signs:

other: No clinilac signs after aplication

Gross pathology:

After 14 days all animals were sacrificed. No macroscipical findings were found.

Interpretation of results:

GHS criteria not met

Conclusions:

The substance is not absorbed in a toxic quantity.

Executive summary:

The substance is not absorbed in a toxic quantity.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Justification for classification or non-classification

Acute toxicity by oral route: Based on the available data the substance akardit is not classified.

Acute toxicity by dermal route. Based on available data the substance Akardit is not classified.