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Fatty acids, C16-18, isotridecyl esters - Mutagenicity in bacteria

 

The mutagenic potential of Fatty acids, C16-18, isotridecyl esters (CAS No. 95912-88-2) was tested in Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 (Banduhn, 1989) equivalent to OECD Guideline 471. Test substance concentrations of 0, 8, 40, 200, 1000 and 5000 µg/plate in tween 80/aqua bidest were tested with and without the addition of a rat liver homogenate metabolising system (S9-mix).

No increase in the frequency of revertant colonies compared to concurrent negative controls were observed in all tested strains, neither in the presence nor in the absence of metabolic activation. Thus, Fatty acids, C16-18, isotridecyl esters did not induce gene mutations in five tested Salmonella strains under the given test conditions.

 

Decyl octadec-9 -enoate- Mutagenicity in bacteria

A disregarded study was available as reliability 4 (Gloxhuber, 1979). The mutagenic potential of Decyl octadec-9-enoate (CAS No. 3687-46-5) was tested in Salmonella typhimurium strains TA 1535, TA 1537, TA 1538, TA 98 and TA 100 equivalent to OECD Guideline 471. Test substance concentrations of 0, 4, 100, 500, 2500 µg/plate was tested with and without the addition of a rat liver homogenate metabolising system (S9-mix). The test substance did not induce reverse mutations in 5 tested Salmonella typhimurium strains, both in the presence and absence of Aroclor 1254 induced rat liver enzymes (S-9 mix).

 

  

Oleyloleate - In vitro cytogenicity in mammalian cells

An in vitro mammalian chromosome aberration test was performed with Oleyloleate (CAS No. 93685 -70 -2) in primary human lymphocytes according to OECD Guideline 473 (Volkner, 1994). Duplicate cultures of human lymphocytes were evaluated for chromosome aberrations in the presence and absence of metabolic activation (rat liver S9-mix).

 

The chromosomes were prepared 18h and 28h after start of treatment with the test article, which was dissolved in ethanol. The treatment interval was 4h with metabolic activation, 18h and 24h without metabolic activation. In each experimental group two parallel cultures were set up. Per culture 100 metaphases were scored for structural chromosomal aberrations.

The following concentrations were evaluated (18h: 3 concentrations; 28h: highest evaluable concentration): with and without S9 mix:

 18h: 10, 60 and 100 µg/ml

 28h: 100 µg/ml

Cyclophosphamide (CPA) and Ethylmethanesulfonate (EMS) were used as positive control substances. In the cytogenetic experiment tested up to 100 µg/mL, no substantial reduction of the mitotic index occurred. Appropriate reference mutagens were used as positive controls and showed statistically significant increases in cells with structural chromosomal aberrations.

There were no biologically and statistically relevant increases in cells with structural aberrations after treatment with the test substance at fixation intervals 18h and 28h (with and without S9 mix). No biologically relevant increase in the frequency of polyploidy metaphases was found after treatment with the test article compared to the frequencies of the negative controls. The test material was therefore considered to be non-clastogenic to human lymphocytes in vitro.

 

Oleyloleate - In vitro mutagenicity in mammalian cells

 

An in vitro Mammalian Cell Gene Mutation Test was performed with Oleyloleate (CAS No. 93685 -70 -2) in Chinese hamster lung fibroblasts (V79) according to OECD Guideline 476 (Poth, 1994).

 

The cells were treated with the test substance in duplicate, together with vehicle (ethanol) and positive controls (Ethylmethanesulphonate and 7, 12-dimethylbenz(a)anthracene). The test substance was dissolved in ethanol and tested with the following concentrations: with and without S9 mix: 10, 30, 60 and 100 µg/mL.4 hour exposures were used both with and without activation in Experiment l and II.

The positive control materials induced marked increases in the mutant frequency indicating the satisfactory performance of the test and of the activity of the metabolising system.

 

 The test material did not induce any toxicologically significant increases in the mutant frequency at any dose level in any of the exposure groups, which included dose levels up to and including the maximum recommended dose level of 100 μg/mL.

Thus, the test material did not induce gene mutations at the HPRT locus in V79 cells under the conditions of the test.


Short description of key information:
Study on the mutagenicity in bacteria was available for CAS No.93685-70-2 and CAS 95912-88-2.

In vitro
CAS 95912-88-2, key, Banduhn 1989, Cognis GmbH, Ames test, RL2- not mutagenic
CAS 93685-70-2, Key, Völkner, 1994, Cognis GmbH, Chr ab, OECD 473, RL2- not clastogenic
CAS 93685-70-2, key, Poth, 1994, Cognis GmbH, HPRT, OECD 476, RL2- not mutagenic

Endpoint Conclusion: No adverse effect observed (negative)

Justification for classification or non-classification

According to DSD (67/548/EEC) or CLP (1272/2008/EC) classification criteria for genetic toxicity, no classification is required.

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