Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Study period:
September - December 1976
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Meets generally accepted scientific standards and acceptable for assessment

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
1977
Report date:
1977

Materials and methods

Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
- Principle of test: equivalent or similar to a standard acute method- Parameters analysed / observed: mortality and clinical signs of intoxication
GLP compliance:
no
Test type:
standard acute method
Limit test:
no

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:
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
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. 127/76 (No. 913)- Expiration date of the lot/batch: not specifiedPurity: 70% of the tested substance; 30% Na2SO4Mw 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 waterTREATMENT OF TEST MATERIAL PRIOR TO TESTING- Final dilution of a dissolved solid, stock liquid or gel: 20% suspension in 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: 115 - 150g- 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 specifiedENVIRONMENTAL CONDITIONSnot specified (laboratory conditions)

Administration / exposure

Route of administration:
other: unspecified, probably gavage
Vehicle:
water
Details on oral exposure:
VEHICLE - Concentration in vehicle: 20% suspension in waterMAXIMUM DOSE APPLIED: 10 g/kg
Doses:
5.02; 6.31; 7.943; 10.00 g/kg
No. of animals per sex per dose:
10
Control animals:
no

Results and discussion

Effect levels
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
6 492 mg/kg bw
Based on:
test mat.
95% CL:
> 5 993 - < 7 031
Clinical signs:
strong diarrhea
Body weight:
not specified
Gross pathology:
not specified

Any other information on results incl. tables

Dose[g/kg] Mortality
5.020 0/10
6.310 5/10
7.943 9/10
10.000 10/10

LD50 = 6.491 (5.993 – 7.031) g/kg b.w.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
very slightly toxic
Executive summary:

The test substance toxicity was evaluated on the basis of mortality and clinical signs of intoxication. According to the study results the value of LD50 of the test substance, Saturnová hněď LB, for male rats is 6.49 g/kg of body weight.