Ethyl trifluoroacetate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From 1983-03-03 to 1983-03-28

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: No GLP compliance. Study performed similarly to the OECD guideline No. 402 with some restrictions: no data on the percentage of the application surface, the animals are not individually housed, an occlusive dressing is used.

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 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

: no data on the percentage of the application surface, the animals are not individually housed, an occlusive dressing is used.

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: 190-200 g - females: 150-160 g
- Fasting period before study: not required
- Housing: per group of 2 or 5 animals in plastic cages (37.5 x 17 x 15 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

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Remarks:

the test item was applied as supplied by the sponsor

Details on dermal exposure:

TEST SITE
- Area of exposure: lateral dorsal area
- % coverage: no data
- Type of wrap if used: the test item is spread on the skin and then the application's area is covered with silver foil and surgical tape

REMOVAL OF TEST SUBSTANCE
- Washing (if done): none
- Time after start of exposure: 24h

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.85 or 1.69 mL/kg
- Concentration (if solution): not applicable, the test item is applied undiluted on the skin
- Constant volume or concentration used: no
- For solids, paste formed: yes/no

VEHICLE
not applicable, the test item is applied undiluted on the skin.

Duration of exposure:

24 hours after the application of the test item on the skin, the dressing was removed. The skin was not washed.

Doses:

Preliminary test: 1011 and 2011 mg/kg bw
Main test: 0 and 2011 mg/kg bw
see details in Table 7.2.3/1

No. of animals per sex per dose:

Preminary test: 2
Main test: 5

Control animals:

yes, concurrent no treatment

Details on study design:

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

Statistics:

no data

Results and discussion

Preliminary study:

No mortality occured at any test doses (1011 and 2011 mg/kg bw).

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 011 mg/kg bw

Based on:

test mat.

Mortality:

No mortality occured.

Clinical signs:

other: No effects were observed.

Gross pathology:

No effects were observed.

Other findings:

none

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 2011 mg/kg bw, Ethyl Trifluoroacetate is not classified for acute dermal toxicity according to the Annex I of the Regulation (EC) 1272/2008 (CLP) and the Annex VI of the Directive 67/548/EEC.

Executive summary:

In an acute dermal toxicity study performed similarly to the OECD guideline No. 402, groups of male and female Sprague-Dawley rats (2 for the preliminary test and 5 animals for the main test/sex/dose) were treated with a single dermal dose of undiluted Ethyl trifluoroacetate (97.3 %). In the preliminary test, 2 doses were tested: 1011 and 2011 mg/kg bw. As no mortality occurred, the highest dose of 2011 mg/kg bw was chosen for the main test. A group consisted in 2 males and 2 females, received no treatment, and served as control group during the main test. The test item was applied on the lateral dorsal area of rats and then the application site was covered with an occlusive dressing (silver foil and surgical tape). 24 hrs after the application of the test item, the dressing was removed and the application site was not washed.

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

No mortalities occurred; neither clinical signs nor effects on body weight gain were observed. Macroscopic examination of the main organs of the animals revealed no apparent abnormalities.

Therefore the LD50 was determined to be higher than 2011 mg/kg bw.

Under the test conditions, Ethyl Trifluoroacetate is not classified for acute dermal 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 dermal toxicity endpoint.