2-nitrophenyl acetate

Acute Toxicity: oral

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

Guideline:

EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Test material

Test material information

Constituent 1

Reference substance name:

Acetic acid, 2-nitrophenyl ester

IUPAC Name:

Acetic acid, 2-nitrophenyl ester

Constituent 2

Reference substance name:

2-nitrophenyl acetate

EC Number:

210-233-1

EC Name:

2-nitrophenyl acetate

Cas Number:

610-69-5

Molecular formula:

C8H7NO4

IUPAC Name:

2-nitrophenyl acetate

Test material form:

solid: crystalline

Details on test material:

- Name of test material (as cited in study report): 2-Nitrophenyl Acetate

- Physical state: solid light yellow
- Analytical purity: 95 % w/w

- Impurities (identity and concentrations):
Phenol <5.0 % (w/w)
2,4-dinitrophenol <5.0 % (w/w)
2,6-dinitrophenol <5.0 % (w/w)
Acetic acid <1.0 % (w/w)
Water <5.0 % (w/w)
2-nitrophenol <5.0 % (w/w)

- Lot/batch No.: 201408
- Expiration date of the lot/batch: unlisted

- Storage condition of test material: The test substance will be stored in dry room in dark in
closed container at the room temperature

- pH: approx. 7 (measurement by contact application of universal indficator pH strip moistened with water)

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: breeding farm VELAZ s.r.o., Únětice, Czech Republic, RČH CZ 21760152
- Age at study initiation: 6-7 weeks
- Weight at study initiation: no data
- Fasting period before study: yes
- Housing: animal room with monitored conditions – 3 animals of one sex in one plastic breeding cage Velaz T4
- Diet (e.g. ad libitum): complete pelleted standard diet for experimental animals ad Libitum (VELAS, a.s., Hrabanov 535, 289 22 Lysá n/L, Czech Republic, CZ 801080-01)
- Water (e.g. ad libitum): drinking tap water ad libitum (quality corresponding to Regulation No. 252/2004 Czech Coll. of Law)
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): room temperature 22 + 3°C, permanently monitored
- Humidity (%): relative humidity 30 – 70 %, permanently monitored
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12-hour light/12 hour dark

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
Batch No.: 5523502
Expiration: 09/2015
Manufacturer: Dr. Kulich Pharma s.r.o., Hradec Králové





MAXIMUM DOSE VOLUME APPLIED: 2000 mg/kg

Doses:

300 mg/kg – 2000 mg/kg – 2000 mg/kg

No. of animals per sex per dose:

3

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: first day: 30 minutes and 3 hours after application
- Necropsy of survivors performed: yes
- Other examinations performed: Nutritious status, body surface, body foramina, thoracic, abdominal and cranial cavity were evaluated.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

No mortality observed.

Clinical signs:

other: No clinical signs of intoxication were observed after dosing 300 and 2000 mg/kg/body weight

Gross pathology:

No pathologic macroscopic changes were diagnosed during pathological examination

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

According to the study results the value of LD50 of the test substance, 2-Nitrophenyl Acetate, for female rats is higher than 2000 mg/kg of body weight.

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.