Ethyl trifluoroacetate

Endpoint summary

Description of key information

Skin: slightly irritating, not classified (2 key studies, reliability Kr. 2, OECD 404)
Eyes: irritating to eyes (Key study, reliability Kr. 2, OECD 405)
Respiratory irritation: no data

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Eye irritation

Endpoint conclusion

Endpoint conclusion:

adverse effect observed (irritating)

Additional information

Skin irritation:

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 (Guillot) similarly to the OECD guideline No. 404. Six male New Zealand Albino rabbits, were dermally exposed to 0.5 mL of undiluted Ethyl trifluoroacetate (purity of 97.3%) to the clipped skin of the flank.Test sites were covered with a semi-occlusive dressing for 4 hours. The arithmethic mean scores calculated within 3 scoring times (24, 48 and 72 hrs) were 1.83 for erythema and 0.0 for edema.

The second key study was conducted in 1987 (Liggett) in accordance with the OECD guideline No. 404. Three male New Zealand White rabbits, were dermally exposed to 0.5 mL of undiluted Ethyl trifluoroacetate (purity of 99.7%) to the clipped skin of the dorso-lumbar region.Test sites were covered with a semi-occlusive dressing for 4 hours. The mean individual scores calculated within 3 scoring times (24, 48 and 72 hrs) were 0.0/0.0/0.0 for erythema and 0.0/0.0/0.0 for edema.

Under the test conditions, Ethyl trifluoroacetate is not classified as skin irritant when applied topically to rabbits according to the Regulation (EC) 1272/2008 (CLP) and to the Directive 67/548/EEC.

 

Eyes irritation:

Two studies were available (Guillot, 1983 and Liggett, 1987). However the study of Guillot was considered as the key study in a worst case strategy as the results of this study conducted to the classification of the substance in category 2. The second study (Liggett, 1987) gave negative results (ie. No eyes irritation was observed) and was therefore considered as a supporting study.

In the key study performed similarly to the OECD No. 405 but not in compliance with the GLP, 0.1 mL of undiluted Ethyl Trifluoroacetate (purity of 97.3%) was instilled into the conjunctival sac of the right eye of 6 male New Zealand albino Rabbits.

The mean scores of all animals were 1.06 for chemosis, 1.1 for conjunctival erythema, 1.78 for corneal opacity and 1.83 for the lesions of the iris to conclude according to the criteria of the Directive 67/548/EEC. Considering another calculation, the mean individual scores were 1.3/1.3/0.3/0.3/1.7/1.3 for chemosis, 1.0/1.7/0.3/0.3/2.0/1.3 for conjunctival erythema, 2.0/1.0/2.0/1.7/2.0/2.0 for corneal opacity and 1.0/1.0/0.0/0.3/1.0/0.3 for the lesions of the iris. In any case, all of these ocular effects were fully reversible within 7 days.

Under the test conditions, as all animals (6/6) presented mean corneal opacity scores higher than 1.0 at 24, 48 and 72h after the end of exposure, Ethyl trifluoroacetate is classified as Eye Irr. 2 (Causes serious eye irritation, H319) according to the Annex I of the Regulation (EC) 1272/2008 (CLP). In another way, as the mean score for iridal lesions of all animals over 24, 48,72h is higher than 1, Ethyl trifluoroacetate is classified as irritating to eyes (Xi, R36) according to criteria of the Annex VI of the Directive 67/548/EEC.

Justification for selection of skin irritation / corrosion endpoint:
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).

Justification for selection of eye irritation endpoint:
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).

Effects on skin irritation/corrosion: slightly irritating

Effects on eye irritation: irritating

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:

Based on the available data:

- ethyl trifluoroacetate is not classified for skin irritation according to the criteria of the Annex I of the Regulation (EC) No 1272/2008 (CLP) and to the criteria of the Annex VI of the Directive 67/548/EEC.

- ethyl trifluoroacetate is self-classified for eye irritation:

         -in Category 2 (H319, Causes serious eye irritation) according to the criteria of the Regulation (EC) No 1272/2008 (CLP) since corneal opacity is ≥1 for at least 2/3 animals,   

- Xi, R36 (irritating to eyes) according to the criteria of the Annex VI to the Directive 67/548/EEC since corneal opacity is ≥2 for at least 2/3 animals.