Registration Dossier

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

Constituent 1
Chemical structure
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:
Reaction products of diazotised 3-amino-5-chloro-4-hydroxybenzenesulphonic acid coupled with 3-methoxyaniline and 4,4'-dinitrostilbene-2,2'-disulphonic acid, chelated with copper, sodium salts
impurity 1
Chemical structure
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