Registration Dossier
Registration Dossier
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EC number: 201-159-0 | CAS number: 78-93-3
Endpoint summary
Administrative data
Description of key information
Methyl ethyl ketone did not demonstrate evidence of skin sensitization potential in guinea pigs.
Key value for chemical safety assessment
Skin sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
The skin sensitization potential of methyl ethyl ketone was assessed in a study performed according to OECD Guidelines for the Testing of Chemicals No. 406 and in compliance with GLP in female Dunkin-Hartley guinea pigs (Denton, 1996). In the main study, 20 animals comprised the methyl ethyl ketone test group and 10 animals comprised the vehicle (Alembicol D) control group. The epicutaneous induction was performed with 0.3 mL of undiluted methyl ethyl ketone to the flank area under occlusive conditions for a 24-hour exposure period on Days 1, 8, and 15. The epicutaneous challenge exposure was conducted with 0.1 mL of undiluted methyl ethyl ketone or a 50% m/m dilution in vehicle for a 6-hour exposure period. Skin reactions were observed and recorded 24 and 48 hours after the challenge exposure. A slight erythematous response was observed in one animal at 24 hours following the challenge application of undiluted methyl ethyl ketone and the 50% m/m dilution in vehicle. The authors judged this response as inconclusive. Necrotic focus on the dose site in one animal in the test group was observed at 24 hours after the challenge exposure to undiluted methyl ethyl ketone. In addition, focal eschar was observed in one animal in the control group and 2 animals in the test group at 48 hours after the challenge exposure to undiluted methyl ethyl ketone. The results of the remaining guinea pigs were negative. Under the conditions of this study, methyl ethyl ketone was not considered not to be a skin sensitizer in guinea pigs.
Justification for classification or non-classification
The substance does not meet the criteria for classification and labelling for this endpoint, as set out in Regulation (EC) No. 1272/2008.
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