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-)

Endpoint summary

Description of key information

Oral route: The value of LD50 of the test substance, Ostazinová námoř. modř H-5R (Reactive Blue 234), for male rats is 7459 mg/kg of body weight.

Inhalation route: data waiving

In accordance with column 2 of REACH Annex VIII, Acute toxicity by inhalation (required in section 8.5.2) does not need to be conducted. The acute toxicity by other route (by dermal route) is available.

Dermal route: The tested substance Ostazinová námořnická modř H-5R (Reactive Blue 234) is not absorbed in toxic amount, therefore is not classified as acute toxic by dermal route as value LD50 > 5000 mg/kg bw.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

August - November 1976

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Meets generally accepted scientific standards and acceptable for assessment

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

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: 110 - 140g
- 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)

Route of administration:

other: unspecified, probably gavage

Vehicle:

water

Details on oral exposure:

VEHICLE
- Concentration in vehicle: 20%

MAXIMUM DOSE APPLIED: 10 g/kg

Doses:

6.31; 7.94; 10.00 g/kg

No. of animals per sex per dose:

10

Control animals:

no

Key result

Sex:

male

Dose descriptor:

LD50

Effect level:

7 459 mg/kg bw

Based on:

test mat.

95% CL:

> 6 777 - < 8 208

Mortality:

yes ( see Any other information on results ...)

Clinical signs:

other: vomiting and diarrhea

Gross pathology:

not specified

Dose[g/kg]	Mortality
6.310	1/10
7.943	8/10
10.000	9/10

LD50 = 7.459 (6.777 – 8.208) g/kg b.w.

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, Ostazinová námoř. modř H-5R, for male rats is 7.459 g/kg of body weight.

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

7 459 mg/kg bw

Quality of whole database:

Reliability 2

Acute toxicity: via inhalation route

Link to relevant study records

Reference

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Link to relevant study records

Reference

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

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

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)

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

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

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.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

5 000 mg/kg bw

Quality of whole database:

Reliability 2