Registration Dossier
Registration Dossier
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EC number: 200-662-2 | CAS number: 67-64-1
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:
The sensitising activity of acetone was investigated under conditions applying open epicutaneous exposure. Due to the volatility of the test substance, after open dermal application the amount of applied test substance remaining on the skin and being available for dermal uptake is expected to be reduced.
Acetone was tested in a guinea pig maximization test (protocol of Magnusson and Kligman with modified scale for scoring of skin responses) with a group of 10 female Hartley guinea pigs. Induction was performed by intradermal injection and topical application of 100 % acetone. 21 days later the animals were challenged by topical application of 100 µl acetone on the shaved flank. No positive skin response was found in any of the animals. Acetone was used as vehicle for other test substances (Key study: Nakamura et al., 1994).
The sensitizing potential of acetone was further investigated in the mouse ear swelling assay. Induction consisted of topical application of acetone (100 %, day 0 and 2) to the right ear and scapular subcutaneous injection of 0.05 ml complete Freund's adjuvant (day 2). On day 9, left ear thickness was measured immediately before topical application of the test substance on both sides of the ear, and again 24 hours later (day 10). There was no increase of ear thickness indicating absence of a sensitizing potential (Supporting study: Descotes, 1988).
Additionally, from skin prick tests with human probands using acetone as solvent for other test substances there are no indications of a sensitizing potential. Principally, concerning the used amounts in skin prick tests, a degreasing of the skin and the minor irritation are negligible (for details see Section 7.10.4).
Migrated from Short description of key information:
Guinea pig maximization test: negative (Key study: Nakamura et al., 1994)
Mouse ear swelling assay: negative (Supporting study: Descotes, 1988)
Justification for classification or non-classification
Skin sensitisation: based on negative test results in animal test systems and based on human experience there is no classification of acetone for skin sensitisation
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