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-)

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:

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 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

Test material information

Constituent 1

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

impurity 1

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

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.