Registration Dossier
Registration Dossier
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EC number: 202-490-3 | CAS number: 96-22-0
Endpoint summary
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:
There are no studies available for diethyl ketone. However, the experimental data presented below on the structural analogue methyl ethyl ketone can be used in a read-across approach. A justification of the use of data on methyl ethyl ketone for read-across is given in section 13 of the IUCLID file.
The dermal sensitisation potential of the structural analogue methyl ethyl ketone (MEK) was studied in young Dunkin-Hartley guinea pigs using to the method of Bühler according to OECD Guideline 406 (, 1996). 20 females in each treatment group and 10 females in the control group were used. Based on the results of a pre-test, test group animals were induced epicutaneously with 100 %, of the test item and challenged epicutaneously with 100% or 50 % (m/m) in Alembicol D. Control group animals were treated with Alembicol D during induction and received the same treatment as test group animals for challenge. 1/20 animals treated with undiluted MEK and 1/20 animal treated with 50 % MEK m/m in Alembicol D elicited a slight erythematous response following the challenge application noted as the 24 h-reading but not at the 48 h-reading. These responses were judged as inconclusive. The results for the remaining guinea pigs were negative. Under the conditions of the study, MEK was not considered to be a skin sensitiser in guinea pigs.
MEK is one of the solvents recommended as vehicle for the local lymph node assay (LLNA) in the respective OECD test guideline. Hence, it has been tested many times in the LLNA and has no sensitising potential in this test system.
Ford et al. (1988) reported that diethyl ketone did not produce sensitisation reaction in the human maximisation test performed according to Kligman (1966) and Kligman & Epstein (1975), when tested at a concentration of 4% in petrolatum on the backs of 27 volunteers in a 48-hr closed-patch test.
References
Kligman AM (1966). The identification of contact allergens by human assay.The maximization test. A procedure for screening and rating contact sensitizers. J. Invest. Derm. 47, 393.
Kligman AM and Epstein W (1975).Updating the maximization test for identifying contact allergens. Contact Dermatitis 1, 231.
Migrated from Short description of key information:
The structural analogue methyl ethyl ketone (MEK) has no skin sensitising potential as demonstrated in guinea pigs using the Bühler test and in mice in the LLNA. In human volunteers 4% diethyl ketone did not cause any sensitising reactions. Based on this data, diethyl ketone is not regarded as a skin sensitiser.
Justification for classification or non-classification
Taking into account all available data, diethyl ketone is not subject to classification and labelling for sensitisation according to Directive 67/548/EEC and Regulation 1272/2008/EC.
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