Trisodium [5-[[4-[(3-chloro-2-hydroxy-5-sulphophenyl)azo]-3-hydroxyphenyl]azoxy]-2-[2-(4-nitro-2-sulphophenyl)vinyl]benzenesulphonato(5-)]cuprate(3-)

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

September - October 1988

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:

other company data

Title:

Unnamed

Year:

1988

Report date:

1988

Materials and methods

Test guideline

Qualifier:

no guideline available

Principles of method if other than guideline:

- Principle of test:The sample was applied at a dose of 5000 mg / kg A paste was prepared from sample by adding water and aplied on depilated rat skin of 4 × 6 cm area.- Short description of test conditions: 5 Wistar rats , males, individually caged After 24 h the plaster bandage was removed and followed by observation for 14 days.- Parameters analysed / observed: behaviour, macroscopic examination of organs (probably weight, but not specified)

GLP compliance:

no

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Trisodium [5-[[4-[(3-chloro-2-hydroxy-5-sulphophenyl)azo]-3-hydroxyphenyl]azoxy]-2-[2-(4-nitro-2-sulphophenyl)vinyl]benzenesulphonato(5-)]cuprate(3-)

EC Number:

274-550-7

EC Name:

Trisodium [5-[[4-[(3-chloro-2-hydroxy-5-sulphophenyl)azo]-3-hydroxyphenyl]azoxy]-2-[2-(4-nitro-2-sulphophenyl)vinyl]benzenesulphonato(5-)]cuprate(3-)

Cas Number:

70304-38-0

Molecular formula:

UVCB

IUPAC Name:

trisodium [5-[[4-[(3-chloro-2-hydroxy-5-sulphophenyl)azo]-3-hydroxyphenyl]azoxy]-2-[2-(4-nitro-2-sulphophenyl)vinyl]benzenesulphonato(5-)]cuprate(3-)

impurity 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:

SOURCE OF TEST MATERIAL- Source and lot/batch No.of test material: Saturnová hněď LB, sample No. 60/88Mw 358.76STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL- Storage condition of test material: not specified- Solubility and stability of the test substance in the solvent/vehicle: 20 g/L of water

Specific details on test material used for the study:

TREATMENT OF TEST MATERIAL PRIOR TO TESTING- Final dilution of a dissolved solid, stock liquid or gel: a paste with water was prepared from sample

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS- Source: not specified- Age at study initiation: not specified- Weight at study initiation: 204 – 220 g - Fasting period before study: not specified- Housing: individually in cage - Diet (e.g. ad libitum): not specified- Water (e.g. ad libitum): not specified- Acclimation period: not specified ENVIRONMENTAL CONDITIONSnot specified (laboratory conditions)

Administration / exposure

Type of coverage:

occlusive

Vehicle:

water

Details on dermal exposure:

TEST SITE - Area of exposure: 4 × 6 cm REMOVAL OF TEST SUBSTANCE - Washing (if done): not specified - Time after start of exposure: 24 h TEST MATERIAL - Amount(s) applied (volume or weight with unit): 5000 mg/ kg - For solids, paste formed: yes, sample mixed with water

Duration of exposure:

24 h

Doses:

5000 mg/ kg

No. of animals per sex per dose:

5 males

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days - Frequency of observations: before exposure and after observation period before autopsy - Necropsy of survivors performed: yes - Other examinations performed: clinical signs, body weight, macroscopic examination of organs

Results and discussion

Effect levels

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

5 000 mg/kg bw

Based on:

test mat. (total fraction)

Mortality:

no

Clinical signs:

no clinical signs of intoxication

Gross pathology:

No pathomorphological changes in the macroscopic examination of organs.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

LD50> 5000 mg/kg

Executive summary:

The tested substance Saturnová hněď LB (Direct Brown 103 now) is not absorbed in toxic amount, therefore it is not classified as acute toxic by dermal route.

LD₅₀> 5000 mg/kg