Registration Dossier

Administrative data

Description of key information

Not expected to be skin sensitising

Key value for chemical safety assessment

Skin sensitisation

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

There are no information about skin sensitisation potential of propiophenone, thus the available data on the structural analogous acetophenone have been taken into account. The Read Across approach can be considered appropriate for the assessement of skin sensitisation. Details can be found in the Read Across justification document attached in section 13 of IUCLID.

Modified Draize test was performed to assess the acetophenone potential to induce allergic contact dermatitis in guinea pigs. For each test material preliminary irritation tests were done in guinea pigs to determine concentrations suitable for sensitization testing. Guinea pigs were then treated by intradermal injection to induce sensitization and challenged 2 weeks later by both intradermal injection and topical application. When there was no evidence of sensitization the induction and challenge procedures were repeated. The Injection challenge concentration was 0.25 %, while the application challenge concentration (ACC) was 20 %. The test item does not shown signs of sensitisation potential (Sharp, 1978).

Furthermore, a maximization test (Kligman, 1966) on acetophenone at 2 % concentration showed no reactions on human subjects (Kligman, 1971).

Respiratory sensitisation

Endpoint conclusion
Endpoint conclusion:
no study available

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), 3.4 Respiratory or skin sensitisation section, skin sensitizer means a substance that will lead to an allergic response following skin contact.

Substances shall be classified as skin sensitisers (Category 1):

(a) if there is evidence in humans that the substance can lead to sensitisation by skin contact in a substantial number of persons; or

(b) if there are positive results from an appropriate animal test (e.g. Local lymph node assay, Guinea pig maximisation test, Buehler assay)

On the basis of the available information, the substance is expected to be non skin sensitising.

In conclusion, propiophenone does not meet the criteria to be classified as skin sensitizer, according to the CLP Regulation (EC 1272/2008).