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

Acute Toxicity: oral

Administrative data

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

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1996

Report date:

1996

Materials and methods

Test guideline

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

Test material

Test material information

Constituent 1

Reference substance name:

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

EC Number:

250-792-9

EC Name:

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

Cas Number:

31765-95-4

Molecular formula:

C44H24Cu2N8O17S4.4Na

IUPAC Name:

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

additive 1

Reference substance name:

Sodium sulphate

EC Number:

231-820-9

EC Name:

Sodium sulphate

Cas Number:

7757-82-6

Molecular formula:

H2O4S.2Na

IUPAC Name:

disodium sulfate

Test material form:

solid: particulate/powder

Details on test material:

0.9 % Spolostan 4P1.6 % SireneX12-L

Specific details on test material used for the study:

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

Test animals

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

Administration / exposure

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).

Results and discussion

Effect levels

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.

Applicant's summary and conclusion

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).