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Description of key information

Only one study of Acute Toxicity is available. This study meets National standarts method with acceptable restrictions.

Klimish score 2.

Acute Toxicity/Oral LD50=6,16 g/kg

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:
8.-11. 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:
The study report contains the limited information on the test conditions because the study has been performed in 1976 . However available information is sufficient to conclude on the classification of the substance. Further the test was performed on the vertebrates and use of results from old experimental studies is one of the options to provide information requested by REACH. New experimental studies with vertebrates must only be conducted if there is no adequate existing information.
GLP compliance:
no
Test type:
other: unknown
Limit test:
no
Species:
rat
Strain:
Wistar
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS- Weight at study initiation: 110-145 g
Route of administration:
oral: unspecified
Vehicle:
water
Details on oral exposure:
VEHICLE- Concentration in vehicle: 20% w/w
Doses:
7,943 g/kg10,00 g/kg12,59 g/kg15,85 g/kg
No. of animals per sex per dose:
10 animals per dose
Control animals:
no
Details on study design:
- Duration of observation period following administration: 14 days- Frequency of observations and weighing: no data- Necropsy of survivors performed: yes- Other examinations performed: clinical signs
Key result
Sex:
male
Dose descriptor:
LD50
Effect level:
11.66 other: g/kg
Based on:
test mat.
95% CL:
> 10.48 - < 12.98
Mortality:
Number of deaths of each level: 7.943 g/kg: 0 10.00 g/kg: 3 12.59 g/kg: 6 15.85 g/kg: 9
Clinical signs:
clinical signs – diarrhea
Gross pathology:
7.943 g/kg: survived animal – kidneys – colored, in one animal – changes at lung furthermore10.00 g/kg: survived animal – kidneys – colored in 4 animals, changes at lung in 3 animalsdead animals (3) – lung, kidney – congested, spleen – lights, intestine – fulfilled with test substance, organs colored12.59 g/kg: survived animal – kidneys – colored in 3 animals, changes at lung in 1 animalsdead animals (6) – intestine – fulfilled with test substance, organs colored15.85 g/kg: survived animal – kidneys – colored dead animals (9) – intestine – fulfilled with test substance, organs colored, exudate in abdominal cavity
Interpretation of results:
GHS criteria not met
Conclusions:
Based on determined value LD50 = 11,66 g/kg, the tested substance REACTIVE ORANGE 5 has not been classified as acute toxic by the oral route.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
11 660 mg/kg bw

Additional information

Justification for classification or non-classification

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