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

Acute Toxicity: dermal

Administrative data

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

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 402 (Acute Dermal Toxicity)

Version / remarks:

1981

Deviations:

not specified

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

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 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

Administration / exposure

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

Results and discussion

Effect levels

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.

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 dermal exposure according to conditions listed in Regulation (EC) 1272/2008 (CLP).