Ethyl trifluoroacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1983-03-03 to 1983-03-25

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Study performed similarly to OECD guideline 401 but without GLP compliance.

Cross-reference

Cross-reference 1

Reason / purpose for cross-reference:

reference to same study

Cross-reference 2

Reason / purpose for cross-reference:

reference to other study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1983

Report date:

1983

Materials and methods

Test guideline

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Deviations:

no

Principles of method if other than guideline:

not applicable

GLP compliance:

not specified

Test type:

standard acute method

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Ethyl trifluoroacetate

EC Number:

206-851-6

EC Name:

Ethyl trifluoroacetate

Cas Number:

383-63-1

Molecular formula:

C4H5F3O2

IUPAC Name:

ethyl 2,2,2-trifluoroacetate

Details on test material:

- Name of test material (as cited in study report): Trifluoroacetate d'ethyle
- Physical state: clear liquid
- Stability under test conditions: assume to be stable (sponsor responsibility)
- Storage condition of test material: no data
- Other: density: 1.19

Test animals

Species:

rat

Strain:

Sprague-Dawley

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: centre d'élevage d'IFFA CREDO (69210 St-Germain sur l'Arbresle, France)
- Age at study initiation: 6-7 weeks
- Weight at study initiation: males : 180-190 g - females: 150-160 g
- Fasting period before study: yes, no water 17 hours before the gavage. The animals can eat and drink 3 hours after the gavage.
- Housing: per group of 2 or 5 animals in plastic cages (37.5 x 23.5 x 16.0 cm) with sawdust litter
- Diet (e.g. ad libitum): Souriffarat diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: no data

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 1.5 °C
- Humidity (%): 55 +/- 15%
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): no data

IN-LIFE DATES: From: To: no data

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Remarks:

the test item is administered as supplied by the sponsor

Details on oral exposure:

VEHICLE
Not applicable, the test item is administered as supplied by the sponsor

MAXIMUM DOSE VOLUME APPLIED: 5010 mg/kg corresponded to 4.21 mL/kg (see details on Table 7.2.1/1)

DOSAGE PREPARATION (if unusual): not applicable

CLASS METHOD (if applicable)
Not applicable

Doses:

preliminary test: 1011, 2511 and 5010 mg/kg
Main test: 0 and 5010 mg/kg bw

No. of animals per sex per dose:

preliminary test: 2
main test: 5

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: clinical signs: 1h, 2h and 6h after the administration of the test item and then daily until the end of the test. weighing: day 1, 2, 4, 7 and 14 after the administration of the test item.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopic observations

Statistics:

no data

Results and discussion

Preliminary study:

No mortality was observed at any tested doses. No further data.

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 010 mg/kg bw

Based on:

test mat.

Mortality:

No mortality was observed at the tested dose (5010 mg/kg bw).

Clinical signs:

other: weariness was observed in all animals (males and females) 2h after the gavage. This effect was observed during 24h in males and 72h in females.

Gross pathology:

no effects were observed.

Other findings:

no other findings

Any other information on results incl. tables

no other information.

Applicant's summary and conclusion

Interpretation of results:

not classified

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

Under the test conditions, since the LD50 is higher than 5010 mg/kg bw, Ethyl Trifluoroacetate is not classified for acute oral toxicity according to the Annex I of the CLP regulation 1272/2008 and the Annex VI of the Directive 67/548/EEC.

Executive summary:

In an acute oral toxicity study performed similarly to the OECD guideline No. 401, groups of male and female Sprague-Dawley rats (2 for the preliminary test and 5 animals/sex/dose for the main test) were administered by gavage a single oral dose of undiluted Ethyl trifluoroacetate (97.3 %). In the preliminary test, 3 doses were tested: 1011, 2511 and 5010 mg/kg bw. As no mortality occurred, the highest dose of 5010 mg/kg bw was chosen for the main test. A control group consisted in 2 males and 2 females, treated with deionized water, was also tested during the main test.

Clinical signs and mortality were checked 1h, 2h and 6h after the administration of the test item and then daily until the end of the test (14 days). The body weight gain was measured at day 1, 2, 4, 7 and 14 after the administration of the test item. 14 days after the gavage with ethyl Trifluoroacetate, the animals were killed and necropsied for macroscopic observations.

Two hours after the administration of the test item at 5010 mg/kg bw (main test), weariness was observed in all animals (males and females). This effect was observed during 24h in males and 72h in females. No mortality was observed neither in the treated group nor in the control group. Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Therefore the LD50 was determined to be higher than 5010 mg/kg bw.

Under the test conditions, Ethyl Trifluoroacetate is not classified for acute oral toxicity according to the Annex I of the Regulation (EC) 1272/2008 (CLP) and the Annex VI of the Directive 67/548/EEC.

This study is considered as acceptable and satisfies the requirement for acute oral toxicity endpoint.