Registration Dossier

Administrative data

Description of key information

Skin irritation/corrosion: corrosive
Eye irritation/corrosion: corrosive

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (corrosive)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
adverse effect observed (irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

In vitro skin irritation / corrosion

The potential of Ethylene diformate to cause skin corrosion was evaluated using the EPISKIN™ in vitro Reconstructed Human Epidermis (RHE) model in a study performed according to OECD guideline 431 under GLP conditions (Warren, 2012). Duplicate tissues were treated with the undiluted test substance for 3, 60 and 240 min. Concurrent negative (0.9% sodium chloride solution) and positive (glacial acetic acid) were included for an exposure period of 240 min. Following exposure, the mean tissue viability was determined using the MTT reduction assay and compared to that of the negative control.

The relative mean tissue viability after 3, 60 and 240 min exposure was 92.4, 48.4 and 19.7% of the negative control value. The positive control-treated tissues yielded a relative mean tissue viability of 5.7%.

Based on these results and according to the evaluation criteria of the study, the substance is considered to be corrosive to the skin.

In vivo skin irritation / corrosion

This information is not available.

Based on the available in vitro data, the substance fulfils the criteria for classification as skin corrosive (Category 1B) according to Regulation (EC) No 1272/2008. Therefore, an in vivo skin irritation study does not need to be conducted in accordance with Column 2 of Annex VIII, Section 8.1, of Regulation (EC) No 1907/2006.

 

In vivo eye irritation / corrosion

Ethylene diformate was tested in an in-vivo study applying different volumes of the undiluted test substance to rabbit eyes (Carpenter, 1946). In groups of 5 albino rabbits (no further information given), 0.005 to 0.02 mL of the undiluted test substance were applied in a single application without washing. The eyes were observed and reactions were evaluated 18-24 h after application. The individual numerical scores of each eye treated with a given volume or concentration of a chemical were added together and then divided by the number of eyes to obtain the score of the injury caused by the treatment. The level of 5 was selected as representative of severe injury. This figure corresponded to necrosis, visible after staining and covering about 3/4 of the surface of the cornea; or a more severe necrosis covering a smaller area. The injury grade, after application of 0.005 mL and 0.02 mL of the undiluted test substance resulted in a calculated score of ≥ 5 out of five eyes after 18-24 h.

Based on these results, along with the available data on skin irritation/corrosion, the substance is considered to be corrosive and to cause irreversible effects on the eye.

Conclusion for irritation/corrosion

Ethylene diformate has been tested for skin corrosion in vitro and for eye irritation/corrosion in vivo. The available data consistently show that the substance is corrosive to the skin and eye, causing irreversible effects on the latter.


Justification for selection of skin irritation / corrosion endpoint:
There is only one study available.

Justification for selection of eye irritation endpoint:
There is only one study available.

Effects on skin irritation/corrosion: corrosive

Effects on eye irritation: corrosive

Justification for classification or non-classification

The available data on the skin and eye irritating/corrosive potential of Ethylene diformate meet the classification criteria for Skin Corrosive Category 1B (H314: Causes severe skin burns and eye damage) and Irreversible Eye Damage Category 1 (H318: causes serious eye damage) according to Regulation (EC) 1272/2008 and for R34 (Causes burns) according to Directive 67/548/EEC.