Registration Dossier

Administrative data

Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2015

Materials and methods

Test guideline
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

Test material

Reference
Name:
Unnamed
Type:
Constituent

Test animals

Species:
rat
Strain:
Wistar
Sex:
female

Administration / exposure

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

Results and discussion

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

Any other information on results incl. tables

 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

Applicant's summary and conclusion

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.