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Description of key information

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
Reliability:
1 (reliable without restriction)
Qualifier:
according to
Guideline:
EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
Deviations:
not specified
GLP compliance:
yes (incl. certificate)
Test type:
acute toxic class method
Species:
rat
Strain:
Wistar
Sex:
female
Route of administration:
oral: gavage
Vehicle:
water
Remarks:
Aqua pro injectione
Doses:
3 doses, 300 mg/kg and 2000 mg(kg
No. of animals per sex per dose:
3
Control animals:
not specified
Clinical signs:
No clinical signs of intoxication were observed during the study
Body weight:
Body weight was recorded and weight increments were calculated in all animals. Weight increments were adequate to species, sex and age of animals in experiment.
Gross pathology:
No pathologic macroscopic changes were diagnosed during pathological examination
 Dose  Number and sex of animals  Mortality  Clinical Signs of intoxication   Pathological findings
 300 mg/kg  3 females, step no. 1  0  0  0
 2000 mg/kg  3 females, step no. 2  0  0  0
 2000 mg/kg  3 females, step no. 3  0  0  0
Interpretation of results:
practically nontoxic
Remarks:
Migrated information Criteria used for interpretation of results: EU
Executive summary:

The test substance toxicity was evaluated on the basis of mortality, clinical signs of intoxication, body weight increments during the observation period and necropsy findings at the end of study. The test substance administered at the dose of 300 and 2000 mg/kg caused no death of animals. No clinical signs of intoxication were detected during the whole study in all nine animals. No pathologic macroscopic changes were diagnosed during pathological examination. According to the study results the value of LD50 of the test substance, 2-methoxy-5-nitrophenyl acetate, for female rats is higher than 2000 mg/kg of body weight.

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
Value:
2 000 mg/kg bw

Additional information

Justification for classification or non-classification