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Key value for chemical safety assessment

Additional information

The ability of Propanediol Dicaprylate to induce mutagenicity in the Bacterial Reverse Mutation test and in the in vitro cell gene mutation test with mouse lymphoma cells and chromosome aberrations in cultured peripheral human lymphocytes was evaluated.

 

In vitro Tests:

Propanediol Dicaprylate was tested in a Bacterial Reverse Test (Ames Test). 5 concentrations (0.06, 0.19, 0.56, 1.67 and 5 µL/ plate) of the test material were applied to 4 different strains of Salmonella typhimurium ((TA98, TA100, TA1535 and TA1537) and on strain of Escherichia coli (WP2 uvrA (pKM101)) in the absence or presence of metabolic activation. The substance did not induce reverse mutations with or without the metabolic activation.

 

In a chromosome aberration test, Propanediol Dicaprylate did not induce a statistically significant or biologically relevant increase in the number of cells with chromosome aberrations in the absence or presence of metabolic activation, in either of the 2 independently repeated experiments, in cultured peripheral human lymphocytes.

No effects of the tes material on the number of polyploid cells and cells with endoreduplicated chromosomes were observed both in the absence and presence of S9 -mix. Propanediol Dicaprylate does not disturb mitotic processes and cell cycle progression and does not induce numerical chromosome aberration, with or without the metabolic activation.

 

In a cell gene mutation test, in L5178Y mouse lymphoma cells, Propanediol Dicaprylate did not induce a significant increase in the mutation frequency in absence or presence of metabolic activation, in either of the 2 independently repeated experiments. Propanediol Dicaprylate is not mutagenic in the mouse lymphoma L5178Y test system.


Short description of key information:
In vitro:
Non-mutagenic and non-promutagenic in the Bacterial Reverse Mutation assay with S. typhimurium TA98, TA100, TA1535, TA1537 and E. coli WP2 uvrA (pKM101), with and without metabolic activation (OECD guideline 471)

Not mutagenic in the cell gene mutation test in L5178Y mouse lymphoma cells (OECD guideline 476)

Non-clastogenic in the chromosome aberration test in cultured peripheral human lymphocytes, with and without metabolic activation (OECD guideline 473).

In vivo:
Read across from 1,3 propanediol: not mutagenic in the Micronucleus Test, with mice Hsd/Win: NMRI.
Read across from 1,3 propanediol: 1,3-propanediol can be metabolized to malondialdehyde by liver homogenate at a rate of 5.6 nmol/h/100 mg tissue protein in vitro (Slow oxidation of 1,3-propanediol by liver homogenates in vitro was reported and considered to be a minor pathway in vivo)

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

The results are conclusive but not sufficient for the classification of Propnaediol Dicaprylate with regard to mutagenicity/genetic toxicity.