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EC number: 304-149-5 | CAS number: 94246-75-0
Acute Toxicity: dermal
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:
- 1 991
- 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 movement
After 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
- 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 18-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-13λ³,15λ³-dioxa-1λ⁴,2-diaza-14-cuprahexacyclo[12.11.0.0³,¹².0⁴,⁹.0¹⁶,²⁵.0¹⁷,²²]pentacosa-1,4(9),5,7,10,16,18,20,22,24-decaene-14,14-bis(ylium)-13,15-diide-10,20,24-trisulfonate
- 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 145/91
Mw 891.9
Solubility: 160 g/L of water
Constituent 1
impurity 1
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 CONDITIONS
not 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:
- other: 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 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.
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