Methyltrioctylammonium chloride

Endpoint summary

Key value for chemical safety assessment

Genetic toxicity in vitro

Description of key information

Gene mutation in vitro:

Ames test:

The test chemical Methyltrioctyl ammonium chloride (CAS no 5137 -55 -3) did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Chromosome aberration study:

The test chemical Methyltrioctyl ammonium chloride (CAS no 5137 -55 -3) does not exhibit gene mutation in the mammalian cells in vitro. Hence the test chemical is not likely to be a gene mutant as per the criteria mentioned in CLP regulation.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed (negative)

Genetic toxicity in vivo

Endpoint conclusion

Endpoint conclusion:

no study available

Additional information

Gene mutation in vitro:

Ames test:

Data available for the test chemicals was reviewed to determine the mutagenic nature of Methyltrioctyl ammonium chloride (CAS no 5137 -55 -3). The studies are as mentioned below:

Gene mutation toxicity study was performed to determine the mutagenic nature of two test chemicals. The test chemicals was dissolved in distilled water or DMSO as the solvent and used at dose level of 0, 0.05, 0.1, 0.5, 1, 5 or 10µg/plate for test chemical 1 and 0, 0.01, 0.05, 0.1, 0.5, 1, 5 or 10 µg/plate for test chemical 2. The exposure duration was 48 hrs at 37˚C. Concurrent solvent and negative control chemicals were also included in the study. The test chemicals did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence they are not likely to classify as a gene mutant in vitro.

Based on the data available, the test chemical did not induce gene mutation in Salmonella typhimurium strains TA98 and TA100 in the presence and absence of S9 metabolic activation system and hence it is not likely to classify as a gene mutant in vitro.

Chromosome aberration study:

Data available for the test chemicals was reviewed to determine the mutagenic nature of Methyltrioctyl ammonium chloride (CAS no 5137 -55 -3). The studies are as mentioned below:

In a gene toxicity test, Chinese Hamster Ovary (CHO) cells were exposed to the test chemical in the concentration of 0, 0.625, 1.25, 2.5 or 5mM and with and without metabolic activation for 3 hours. The results showed that there was no evidence of cytotoxicity after treatment. Independently of tested test chemical concentration, the results showed no evidence of gene toxicity in the presence of metabolic activation system. In the concentrations 1.25 or 2.5mM of the test chemical concentration in the absence of metabolic activation system, the results showed evidence of gene toxicity. Therefore, it is considered that the test chemical in the concentration of 0, 0.625, 1.25, 2.5 or 5 microM does not cause genetic mutation(s) when CHO cells are exposed to the test chemical in the presence of metabolic activation and in the concentration of 1.25 or 2.5 microM may cause genetic mutation(s) when CHO cells are exposed to the test chemical in the absence of metabolic activation.

In another vitro mammalian cell transformation assay was performed to determine the mutagenic nature of the test chemical. The test chemical was dissolved in DMSO as the solvent and used at dose level of 0, 0.01, 0.05, 0.1, 0.5, 1, 5, 10, 20, 50, 100 or 300µg/mL. Pregnant Syrian golden hamsters were killed on days 13 and 14 of gestation for preparation of target cells and feeder-layer cells respectively. Embryos without heads and viscera were minced with scissors,a nd trypsinized with 0.25% trypsin. Inocula of 10000000 embryo cells per 75-cm’ flask were incubated at 37°C in a humidified atmosphere of 10% CO2 in air. When they became confluent primary cultures were trypsinized, dispensed in lots of 5000000 cells in glass ampules, and stored in liquid nitrogen for use as target and feeder-layer cells. The assay takes 15 days from start to finish. On Day 0, an ampule of cryopreserved primary cells prepared as feeder-layer cells was rapidly thawed and plated in a 75-cm2 flask containing 20 ml of the culture medium. The medium was changed every day. On day 3, an ampule of cryopreserved primary cells prepared as target cells was also rapidly thawed and plated in a 75-cm2 flask. On day 4, the feeder cells which were shifting from a stage of logarithmic growth to a stationary phase were irradiated with 5000 R from a linear accelerator, trypsinized, and then plated at 6 x lo4 tells/60-mm dish in 2 ml of complete medium. On day 5, the target cells which were approximately 80 -90% confluent were trypsinized, and a suspension of 500 target cells in 2 ml of complete medium was then added to each of the dishes plated the day before with irradiated feeder-layer cells. On day 6, an appropriate dose of the test chemical in a volume of 4 ml was added, giving a total volume of 8 ml of medium in each dish. Nine dishes were used for each dose level in all the experiments (in a few cases only eight or seven dishes were used for controls). On day 14, the cultures werefixed with absolute methanol for 10min and stained with Giemsa solution for 45 min or more. The stained dishes were examined with a stereoscopic dissection microscope to count normal and transformed colonies. The exposure duration was 8 days. Concurrent solvent and negative control chemicals were also included in the study. The test chemical did not induce cell transformation in the Pregnant Syrian golden hamsters embryo cell line used and hence it is not likely to classify as a gene mutant in vitro.

Based on the data available for the the test chemical, Methyltrioctyl ammonium chloride (CAS no 5137 -55 -3) does not exhibit gene mutation in the mammalian cells in vitro. Hence the test chemical is not likely to be a gene mutant as per the criteria mentioned in CLP regulation.

Justification for classification or non-classification

Based on the data available for the target chemical and its read across, Methyl(trioctyl)azanium chloride (CAS no 5137 -55 -3) does not exhibit gene mutation in vitro in Ames assay and mammalian cell gene mutation assay. Hence the test chemical is not likely to classify as a gene mutant as per the criteria mentioned in CLP regulation.