Registration Dossier

Administrative data

Description of key information

Two studies have been identified as having assessed the skin irritation/corrosion potential and eye irritation potential of ethyl methyl carbonate. Both studies have determined that ethyl methyl carbonate is not irritating to the skin or eyes. Respiratory irritation was determined from an acute inhalation toxicity study. 

Key value for chemical safety assessment

Skin irritation / corrosion

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Additional information

Skin corrosion/irritation:

The test substance was applied to intact skin of rabbits with a semi-occlusive wrap. One treated animal showed slight erythema one hour post patch removal. Another animal also presented with slight erythema at 24 and 48 hours after patch removal. All irritant effects observed were resolved by the end of the 72 hour observation period. Based on the findings of this study, ethyl methyl carbonate is considered to be not irritating to the skin.

Eye irritation:

0.1ml of undiluted test material was applied to six rabbit eyes followed by examinations at 1, 24, 48 and 72 hours following treatment. No corneal effects were observed during the study. Iridial inflammation was observed in one treated eye 1 hour after treatment, but no other iridial effects were noted. Minimal to moderate conjunctival irritation was observed in all treated eyes an hour after treatment. In one eye conjunctival redness persisted to the 24 -hour observation. All treated eyes appeared normal 24 -48 hours post-treatment. Mean overall scores at 1, 24, 48, and 72 hours were 4.8, 0.3, 0 and 0 respectively. Based on the findings of this study, ethyl methyl carbonate is not considered to be irritating to the eyes.

Respiratory irritation:

Respiratory irritation was determined from an acute inhalation toxicity study. The key study followed the OECD 403 guideline and was GLP-compliant. A limit test using five male and five female rats was conducted with nose only exposure for 4 hours. Test animals were observed over a 14-day period and surviving animals were sacrificed and necropsied. The respiratory tract was macroscopically examined for signs of irritancy or local toxicity. No significant clinical effects occurred and no macroscopic effects were observed. Ethyl methyl carbonate is not considered to be a respiratory irritant.

Justification for classification or non-classification

Based on the results of the skin corrosion/irritation study and eye irritation study, ethyl methyl carbonate is not classified as a skin, eye or respiratory irritant under:

- Directive 67/548/EEC criteria

- Regulation 1272/2008 (EU CLP GHS) criteria

No classification for skin irritation/corrosion, eye irritation or respiratory irritation is applied to ethyl methyl carbonate in Annex VI of the CLP Regulation No.1272/2008.