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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 specifiedENVIRONMENTAL CONDITIONSnot 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:
vomiting and diarrhea
Body weight:
not specified
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 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
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)
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:
no clinical signs of intoxication
Body weight:
normal weight gain
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

Additional information

Justification for classification or non-classification

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