Ethyl trifluoroacetate

Endpoint summary

Description of key information

Oral: LD50 > 5000 mg/kg bw, 2 key studies (Reliability Kr.2, OECD 401)
Inhalation: no data , waiving
dermal: LD50 > 2011 mg/kg bw (Key study, Reliability Kr.2, OECD 402)

Key value for chemical safety assessment

Acute toxicity: via oral route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

5 000 mg/kg bw

Quality of whole database:

Good quality of whole database.

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

LD50

Value:

2 011 mg/kg bw

Quality of whole database:

Good quality of whole database.

Additional information

Oral route:

Two different studies conducted on ethyl trifluoroacetate were considered as key studies. Both studies are not in compliance with GLP but present a good reliability (Kr. 2).

The first key study was conducted in 1983 (Monnot) similarly to the OECD guideline No. 401. Groups of male and female Sprague-Dawley rats were given 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.. 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.

The second key study was conducted in 1987 (Gardner) in accordance with the OECD guideline No. 401. Groups of male and female Sprague-Dawley rats were given by gavage a single oral dose of undiluted Ethyl trifluoroacetate (99.7 %). In the preliminary test, 2 doses were tested: 500 and 2000 mg/kg bw. As no mortality occurred, the highest recommended dose of 5000 mg/kg bw was chosen for the main test.Clinical signs and mortality were checked soon after dosing and then at frequent intervals for the remainder of day 1 (day of dosing). No death occurred in the main test at 5000 mg/kg bw. Piloerection, abnormal body carriage (hunched posture), abnormal gait (waddling) and lethargy were observed in all animals of both sex, treated with 5000 mg/kg bw, during the 4 hrs period after dosing. Pilo-erection alone persisted on day 2. There were no other clinical signs and recovery, as judged by external appearance and behaviour was apparently complete by day 3. No abnormalities were observed after necropsy. Therefore the LD50 was determined to be higher than 5000 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.

 

 

Dermal route:

A study was identified as a key study (Monnot, 1983). In this acute dermal toxicity study performed similarly to the OECD guideline No. 402 but not in compliance with the GLP, groups of male and female Sprague-Dawley rats 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. 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.

Justification for selection of acute toxicity – oral endpoint
Key study performed similarly to OECD guideline 401 but without GLP compliance.

Justification for selection of acute toxicity – dermal endpoint
Key study performed similarly to OECD guideline 402 but without GLP compliance.

Justification for classification or non-classification

Harmonized classification:

No harmonized classification is available for human health according to the Regulation (EC) No. 1272/2008 including the ATP2.

Self classification:

Oral route:

Based on the available data, the test item is:

- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is higher than 2000 mg/kg bw (and even > 5000 mg/kg bw)

- not classified according to the Directive 67/548/EEC as the LD50 is higher than 2000 mg/kg bw

Dermal route:

Based on the available data, the test item is:

- not classified according to the Regulation (EC) No. 1272/2008 as the LD50 is higher than 2000 mg/kg bw

- not classified according to the Directive 67/548/EEC as the LD50 is higher than 2000 mg/kg bw