Propiophenone

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

The substance and its metabolites did not induce gene mutations in the strains of Salmonella typhimurium nor in the strains of E.coli.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Additional information

The genetic toxicity potential of propiophenone has been investigated taking also into consideration data on the structural analogue acetophenone: the Read Across approach can be considered appropriate for the assessement of genetic toxicity. Details can be found in the Read Across justification document attached in section 13 of IUCLID.

The substance was tested for mutagenic effects in vitro in histidine-requiring strains of Salmonella typhimunum and in tryptophan-requiring strains of E.coli. The following strains of Salmonella typhimunum were used: TA 98, TA 100, TA 1535, TA 1537, TA 1538, G46, C3076, D3052. The following strains of E.coli were used: WP2 and WP2 urvA. The test was performed with and without the addition of rat-liver supernatant as an extrinsic metabolic activation system. The compound was tested at four concentration ranges - 100 to 1000 μg/ml, 10 to 100 μg/ml, 1 to 10 μg/ml, and 0.1 to 1 μg/ml. In order to confirm the results, the plates containing no compound were used as negative control. Each strain was additionally tested in the presence and in the absence of a metabolic activation system with a suitable, known mutagen as positive control.

In the tests performed with and without metabolic activation, the substance gave a negative response. Based on the results of the test it is concluded that the substance and its metabolites did not induce gene mutations in the strains of Salmonella typhimurium nor in the strains of E.coli used.

Furthermore, the study on a similar substance shows that the substance and its metabolites did not induce gene mutations in the strains of Salmonella typhimurium. This study tested the mutagenic effect of the substance on less strains (TA 98, TA 100 and TA 1537) but in higher concentration both without and with metabolic activation. Revertant frequency was less than twice the spontaneous background at levels up to at least 3000 nmoles/plate (360 μg/plate).

Justification for classification or non-classification

According to the CLP Regulation (EC 1272/2008), for the purpose of the classification for germ cell mutagenicity, substances are allocated in one of two categories in consideration of the fact that they are:

- substances known to induce heritable mutations or to be regarded as if they induce heritable mutations in the germ cells of humans or substances known to induce heritable mutations in the germ cells of humans or

- substances which cause concern for humans owing to the possibility that they may induce heritable mutations in the germ cells of humans.

Based on the available data, the test substance did not show any reasons of concern in the test performed.

In conclusion, the substance is not classified for genetic toxicity according to the CLP Regulation (EC 1272/2008).