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Administrative data

Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Feb - March 1991
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:
1991
Report date:
1991

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 1.5 ml water and aplied on depilated rat skin of 4 × 6 cm area.- Short description of test conditions: 5 Wistar rats , males, individually caged Coverage: gauze, Alu-foil, plaster bandage - applicated in such a way not to obstruct the movementAfter 24 h the plaster bandage was removed and followed by observation for 14 days.- Parameters analysed / observed: behaviour, weight, macroscopic examination of organs
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
Tripotassium [5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-4-sulpho-1-naphthyl)azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)
EC Number:
304-149-5
EC Name:
Tripotassium [5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-4-sulpho-1-naphthyl)azo]naphthalene-2,7-disulphonato(5-)]cuprate(3-)
Cas Number:
94246-75-0
Molecular formula:
C23H11ClCuN7O11S3.3K
IUPAC Name:
tripotassium [5-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-4-hydroxy-3-[(2-hydroxy-4-sulpho-1-naphthyl)azo]naphthalene-2,7-disulphonato(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:
Ostazinová námořnická modř H-5R, sample No. 120/76 and 145/91Mw 891.9Solubility: 160 g/L of 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: 254 – 308 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 - Type of wrap if used: gauze, Alu-foil, plaster bandage - application in such a way not to obstruct the movement 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 1.5 ml 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 and weighing: 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.
Mortality:
no
Clinical signs:
no clinical signs of intoxication
Body weight:
normal weight gain
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 Ostazinová námořnická modř H-5R is not absorbed in toxic amount, therefore is not classified as acute toxic by dermal route.

LD50> 5000 mg/kg.