Ethyl difluoroacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP, Guideline study (OECD)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2008

Report date:

2008

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)

GLP compliance:

yes (incl. QA statement)

Test type:

acute toxic class method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl difluoroacetate

EC Number:

207-223-4

EC Name:

Ethyl difluoroacetate

Cas Number:

454-31-9

Molecular formula:

C4H6F2O2

IUPAC Name:

ethyl difluoroacetate

Details on test material:

- Name of test material (as cited in study report): Ethyl difluoroacetate
- Analytical purity: 99.9%
- Lot/batch No.: 33244/106 A
- Stability under test conditions: The stability under storage conditions over the study period was guaranteed by the sponsor, and the sponsor holds this responsibility.
- Storage condition of test material:
- Other: Density [g/mL]: 1.163
- The test substance was homogeneous by visual inspection.

Test animals

Species:

rat

Strain:

Wistar

Sex:

female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Rat / Wistar / HanRcc:WIST(SPF)
- Source: RCC Ltd Laboratory Animal Services
- Age at study initiation: 8-12 years
- Weight at study initiation: Animals of comparable weight (± 20% of the mean weight)
- Fasting period: 16 hours before administration, but water was available ad libitum
- Housing: Single housing
- Diet (e.g. ad libitum): Kliba-Labordiät
- Water (e.g. ad libitum): Tap water ad libitum
- Acclimation period: Acclimatization for at least 5 days before administration.

ENVIRONMENTAL CONDITIONS
- Temperature (°C): The animals were housed in fully air-conditioned rooms. Central air-conditioning guaranteed a range of 20 – 24°C for
temperature.
- Humidity (%): 30 – 70% for relative humidity
- Photoperiod (hrs dark / hrs light): 12 h / 12 h (6.00 a.m. – 6.00 p.m. / 6.00 p.m. – 6.00 a.m.)

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

olive oil

Details on oral exposure:

VEHICLE
Olive oil Ph.Eur./DAB
- Amount of vehicle (if gavage): Undiluted (2000 mg/kg) / Solution (300 mg/kg)
- Justification for choice of vehicle: Olive oil Ph.Eur./DAB had to be used to ensure homogeneity of the preparation.

DOSAGE PREPARATION (if unusual): The test-substance preparation of the 300 mg/kg administration group was produced shortly before the administration by stirring with a magnetic stirrer.

Doses:

300 mg/kg (3 animals)
2000 mg/kg - 2 different groups (6 animals)

No. of animals per sex per dose:

3

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Individual body weights shortly before administration (day 0), weekly thereafter and on the last day of observation.
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: Recording of signs and symptoms several times on the day of administration, at least once each workday for the individual animals; these records are maintained with the raw data.
- other: mortality: A check for any dead or moribund animal was made twice each workday and once on Saturdays, Sundays and on public holidays.
pathology: Necropsy with gross-pathology examination on the last day of the observation period after killing by CO2-inhalation in a
chamber with increasing concentrations over time.

Results and discussion

Effect levels

Sex:

female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: No mortality and no other abnormalities occured.

Mortality:

No mortality occurred.

Clinical signs:

other: Clinical observation in the 2000 mg/kg administration groups revealed impaired general state, dyspnoea, piloerection, exsiccosis, respiration sounds, reduced or no feces and were observed from hour 2 through to study day 2 after administration. No clinica

Gross pathology:

No macroscopic pathologic abnormalities were noted in the animals (2000 mg/kg, 6 females and 300 mg/kg, 3 females) examined on the last day of observation.

Applicant's summary and conclusion

Interpretation of results:

practically nontoxic

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the conditions of this study the median lethal dose of Ethyl difluoroacetate after oral administration was found to be greater than 2000 mg/kg body weight in rats. Therefore, the test substance ethyl difluoroacetate is considered to be practically nontoxic after a single oral administration in rats.