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Administrative data

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Di-tridecamine did not cause gene mutations in Salmonella typhimurium (Ames test) nor were chromosomal aberrations induced in V79 cells nor were gene mutations induced at the HPRT locus in V79 cells. These studies were performed in the absence and presence of metabolic activation. Thus, di-tridecamine is not considered to be genotoxic.

Additional information

Di-tridecamine was tested in the Ames reverse mutation assay using Salmonella typhimurium strains TA98, TA100, TA1535 and TA1537 and Escherichia coli WP2 uvr A at 20 to 5000 µg/plate (standard plate and preincubation test) with and without metabolic activation. Di-tridecamine was cytotoxic (reduced background growth, decrease in the number of revertants, reduction in the titer) in the standard plate test with the Salmonella strains depending on the strain and test conditions from about 50 µg - 100 µg/plate and onwards. For E. coli a cytotoxic effect was observed at doses2,500 µg/plate.

In the preincubation assay cytotoxicity was observed depending on the strain and test conditions from about 6 µg - 12 µg/plate onward (Salmonella strains) or from about 4 µg - 100 µg/plate onward (E. coli). Under the conditions tested, di-tridecamine was not mutagenic in any in the S. typhimurium strains and E.coli WP2 uvr A.

 

In addition, two Ames-Tests with Tridecanamine, N-tridecyl-, branched and linear were conducted in 2018 (nonGLP). The studies were carried out to compare the toxicological properties of two batches of the UVCB DTDA.

The test substance Tridecanamine, N-tridecyl-, branched and linear (PSN 18/0020-1) was tested for ist mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay. Strains tested TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA at a dose range of 0.33 μg - 5300 μg/plate (SPT) and 0.33 μg - 1000 μg/plate (PIT). Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats). No precipitation of the test substance was found with and without S9 mix. A strong bacteriotoxic effect was observed depending on the strain and test conditions from about 33 μg/plate onward. A relevant increase in the number of his+or trp+revertants (factor2: TA 100, TA 98 and E.coli WP2 uvrA or factor3: TA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system. Under the experimental conditions of this study, the test substance Tridecanamine, Ntridecyl-, branched and linear (PSN 18/0020-1) is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation. 

The test substance Tridecanamine, N-tridecyl-, branched and linear (PSN 18/0019-1) was tested for its mutagenic potential based on the ability to induce point mutations in selected loci of several bacterial strains, i.e. Salmonella typhimurium and Escherichia coli, in a reverse mutation assay. Strains tested TA 1535, TA 100, TA 1537, TA 98 and E. coli WP2 uvrA at a dose range of 1.0 μg - 5300 μg/plate (SPT) and 1.0 μg - 2650 μg/plate (PIT). Standard plate test (SPT) and preincubation test (PIT) both with and without metabolic activation (liver S9 mix from induced rats). No precipitation of the test substance was found with and without S9 mix. A strong bacteriotoxic effect was observed depending on the strain and test conditions from about 10 μg/plate onward. A relevant increase in the number of his+or trp+revertants (factor: TA 100, TA 98 and E.coli WP2 uvrA or factorTA 1535 and TA 1537) was not observed in the standard plate test or in the preincubation test without S9 mix or after the addition of a metabolizing system. Under the experimental conditions of this study, the test substance Tridecanamine, Ntridecyl-, branched and linear (PSN 18/0019-1) is not mutagenic in the Salmonella typhimurium/Escherichia coli reverse mutation assay in the absence and the presence of metabolic activation.

 

 

Induction of chromosomal aberrations was tested in an OECD 473 study in which Chinese hamster lung fibroblasts (V79) were exposed to 0.16 to 40 µg/mL di-tridecamine with and without metabolic activation (BASF AG, 2011). Cytotoxicity was observed at least in the highest applied concentration tested and vehicle and positive controls exhibited appropriate responses. No significant increases in chromosomal aberrations upon treatment with di-tridecamine were observed.

 

 

In a GLP-compliant gene (HPRT) mutation assay, according to OECD guideline 476, chinese hamster lung fibroblast (V79) were exposed to di-tridecamine (Harlan, 2012). In the first experiment, cells were exposed for 4 hours at concentrations ranging from 0.04 to 0.45 µg/mL and 0.60 to 9.6 µg/mL, without and with metabolic activity, respectively. In the second experiment, cells were exposed for 24 hours at concentrations ranging from 0.08 to 0.63 µg/mL and for 4 hours at concentrations ranging from 1.3 to 12.5 µg/mL, without and with metabolic activation, respectively. No substantial and reproducible dose dependent increase of the mutation frequency was observed up to the maximum concentration with and without metabolic activation. Tridecanamine, N-tridecyl-, branched and linear is considered to be non-mutagenic in this HPRT assay.

Justification for classification or non-classification

Based on the results of the in vitro genetic toxicity studies, di-tridecamine does not need to be classified according to Directive 67/548/EEC and according to the EU Classification, Labelling and Packaging of Substances and Mixtures (CLP) Regulation (EC) No. 1272/2008.