Registration Dossier

Administrative data

Description of key information

Key value for chemical safety assessment

Skin sensitisation

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not sensitising)
Additional information:

A guinea pig maximisation test was conducted using Dunkin Hartley strain guinea pigs to assess the sensitising potential of ethyl methyl carbonate. For the first induction (intradermal) a 1% v/v test substance concentration in arachis oil BP was used and the second (topical) induction was used undiluted as supplied. The challenge dose (25% and 50% in arachis oil BP) was applied 21 days after the first induction treatment, via topical application to the lateral flanks.

 

Reactions were scored 24 and 48 hours after removal of the challenge patch: no adverse skin reactions were seen in any test or negative control animals. Based on the results of this study, ethyl methyl carbonate is not considered to be a skin sensitiser.


Migrated from Short description of key information:
One key study has been identified as having assessed the skin sensitising potential of ethyl methyl carbonate.

Justification for classification or non-classification

Based on the results of the sensitisation key study (Guinea pig maximisation test for skin sensitisation), ethyl methyl carbonate is not classified as a skin sensitiser under:

- Directive 67/548/EEC criteria

- Regulation 1272/2008 (EU CLP GHS) criteria

No classification for sensitisation is applied to ethyl methyl carbonate in Annex VI of the CLP Regulation No.1272/2008.