Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

December 1989 - March 1990

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:

1990

Report date:

1990

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:

Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate

EC Number:

274-427-8

EC Name:

Tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate

Cas Number:

70210-31-0

Molecular formula:

C43H30N8O14S4.4Na

IUPAC Name:

tetrasodium 8-[[4-[(4-amino-3-sulphonatophenyl)azo]-6-sulphonatonaphthyl]azo]-5-[[6-(benzoylamino)-1-hydroxy-3-sulphonato-2-naphthyl]azo]naphthalene-2-sulphonate

impurity 1

Reference substance name:

Colorless components

IUPAC Name:

Colorless components

Test material form:

solid: particulate/powder

Details on test material:

Other name: Saturnová nám. modř LFG konc. ; sample No. 196/89

Specific details on test material used for the study:

SOURCE OF TEST MATERIAL- Source and lot/batch No.of test material: Saturnová nám. modř LFG konc. ; VCHZ Synthesia Semtín, sample No. 196/89 - Expiration date of the lot/batch: not specifiedPurity: 40 - 50% of the tested substance; 50 - 55% (NaCl, Na2SO4)STABILITY 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 waterTREATMENT OF TEST MATERIAL PRIOR TO TESTING- Final dilution of a dissolved solid, stock liquid or gel: a paste was prepared from sample by adding water

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: 251 – 256 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 Direct Blue 85 (Saturnová nám. modř LFG konc.) is not absorbed in toxic amount, therefore it is not classified as acute toxic by dermal route.

LD₅₀> 5000 mg/kg