Tetrasodium [μ-[[3,3'-[azoxybis[(2-hydroxy-p-phenylene)azo]]bis[4-hydroxy-6-(3-sulphoanilino)naphthalene-2-sulphonato]](8-)]]dicuprate(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:

1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

1987

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

no

Specific details on test material used for the study:

Saturnová šeď LCG: 95.2 % (w/w)black powder

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: TOP VELAZ, Praha, Czech Republic- Weight at study initiation: cca 150 g- Housing: 5 animals per cage, separately by sex, controlled conditions- Diet (e.g. ad libitum): standard commercially produced granular feed 10 g/animal/day- Water (e.g. ad libitum): tap water ad libitum- Fasting period before study: 20 hours- Acclimation period: 1 week ENVIRONMENTAL CONDITIONS - Temperature (°C): 22 ± 3°C - Humidity (%): 40 - 70 % - Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Route of administration:

oral: unspecified

Vehicle:

water

Details on oral exposure:

VEHICLE - Concentration in vehicle: 20 % (w/w) water suspension - Amount of vehicle: calculated based on individual body weight

Doses:

6.310, 7.943, 10.00 and 12.59 g/kg

No. of animals per sex per dose:

5 animals pr sex per dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of observations: immediately after application, after 30 min, after 3 hours, following day morning and afternoon, next days at least once a day - Necropsy of survivors performed: yes - Other examinations performed: clinical signs, body weight, organ appearance and weights, urine (if present) orientation biochemical tests

Statistics:

Inner statistical program PROBIT (1991).

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

9 370 mg/kg bw

Based on:

test mat.

95% CL:

> 8 730 - < 10 062

Mortality:

6.310 g/kg: 0/5 males 0/5 females7.943 g/kg: 3/5 males 0/5 females10.00 g/kg: 2/5 males 3/5 females12.59 g/kg: 5/5 males 5/5 females

Clinical signs:

6.310 g/kgWithout any clinical symptoms of intoxication.7.943 g/kgDiarrhea, disappeared within 4 days. 3 males died.10.00 g/kgDiarrhea, cyanosis. Three animals (2 males/1 female) had symptoms of somnolence. Clinical symptoms disappeared within 3 days. 2 males and 3 females died.12.59 g/kgPiloerection, anemic mucosa, somnolence, bloody nasal discharge in females. One male died the third day after application, all other animals died within two days after application.

Body weight:

Average weight of the test animalsMales6.310 g/kg: 154.9 g (start) 173.5 g (end) +18.6 g increment10.00 g/kg: 164.3 g (start) 172.4 g (end) +8.1 g incrementFemales6.310 g/kg: 154.3 g (start) 168.6 g (end) +14.3 g increment7.943 g/kg: 159.9 g (start) 171.5 g (end) +11.6 g increment(Only doses are listed where survived at least 3 animals.)

Gross pathology:

Died animals: stomach and intestine catarrh.Survived animals: without any pathological symptoms.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance, Direct Black 112, is not classified as acute toxic by oral exposure according to conditions listed in Regulation (EC) 1272/2008 (CLP).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

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:

1996

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

study well documented, meets generally accepted scientific principles, acceptable for assessment

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Version / remarks:

1981

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Specific details on test material used for the study:

Saturnová šeď LCG: 95.2 % (w/w)black powder

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: TOP VELAZ, Praha, Czech Republic- Weight at study initiation: cca 200 g- Housing: individuai in cage, controlled conditions- Diet (e.g. ad libitum): standard commercially produced granular feed 10 g/animal/day- Water (e.g. ad libitum): tap water ad libitum- Fasting period before study: 20 hours- Acclimation period: 1 week ENVIRONMENTAL CONDITIONS - Temperature (°C): 22 ± 3°C - Humidity (%): 40 - 70 % - Photoperiod (hrs dark / hrs light): 12 hours light / 12 hours dark

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE - Area of exposure: 6 × 6 cm - Type of wrap if used: occlusive REMOVAL OF TEST SUBSTANCE - Time after start of exposure: 24 h TEST MATERIAL - Amount(s) applied (volume or weight with unit): 5.020 g/kg - For solids, paste formed: yes

Duration of exposure:

24 hours

Doses:

5.020 g/kg

No. of animals per sex per dose:

5 animals/sex/dose

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of observations: immediately after application, after 30 min, after 3 hours, following day morning and afternoon, next days at least once a day - Necropsy of survivors performed: yes - Other examinations performed: clinical signs, body weight, organ appearance and weights, urine (if present) orientation biochemical tests

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 000 mg/kg bw

Based on:

test mat.

Mortality:

No animal died.

Clinical signs:

No signs of intoxication were observed.

Body weight:

Average weight of the test animalsMales5.020 g/kg: 207.0 g (start) 263.5 g (end) +56.5 g incrementFemales5.020 g/kg: 200.3 g (start) 234.3 g (end) +34.0 g increment

Gross pathology:

Without any pathological symptoms.

Interpretation of results:

GHS criteria not met

Conclusions:

The test substance, Direct Black 112, is not classified as acute toxic by dermal exposure according to conditions listed in Regulation (EC) 1272/2008 (CLP).

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Justification for classification or non-classification

Based on the test results and according to the CLP criteria for classification and labelling requirements for dangerous substances and preparations, the test substance, Direct Black 112, did not fall into any of quoted categories of toxicity both oral and dermal, and has no obligatory labelling requirement in this respect.