Registration Dossier
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EC number: 807-015-9 | CAS number: 126437-91-0
Endpoint summary
Administrative data
Key value for chemical safety assessment
Additional information
The test substance (source substance) was tested for mutagenicity according to OECD guideline 471with the strains TA 100, TA 1535, TA 1537 and TA 98 of Salmonella typhimurium and with Escherichia coli WP2uvrA.
Three independent mutagenicity studies were conducted (two plate incorporation tests, due to high toxicity and one preincubation test), each in the absence and in the presence of a metabolizing system derived from a rat liver homogenate.
For all studies, the test substance was dissolved in deionized water and each bacterial strain was exposed to 5 dose levels in the first plate incorporation test and to 6 dose levels in subsequent tests. Low dose levels ranged from 0.16 to 50 µg/plate, and high dose levels ranged from 0.5 to 160 µg/plate. The test substance did not precipitate on the plates up to the highest investigated dose of 5000 µg/plate.
In the presence and in the absence of the metabolic activation system the test substance (source substance) did not result in relevant or dose-dependent increases in the number of revertants in any of the bacterial strains.
Justification for selection of genetic toxicity endpoint
Well documented guideline conform, scientific GLP report. No toxicity data are available for 1-Tetradecanaminium, N,N,N-trimethyl-, methyl carbonate (CAS No. 126437-91-0, target substance) which is used as precursor for the N,N,N-trimethyltetradecan-1-aminium oxalate (CAS No. 154858-16-9, source substance). As the chemical structure of both chemicals is almost similar with the exception of the methyl carbonate anion for the target substance instead of the oxalate, read across is made to the source substance. The available studies from the source substance are sufficient to provide toxicological information of the target substance (refer to IUCLID point 13, Assessment reports.001- Read across justification).
Short description of key information:
An Ames test according to OECD 471 was performed with tester strains S. typhimurium TA 1535, TA 1537, TA 98, TA 100 and E. coli WP2 with and without metabolizing system.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
In conclusion, the test substance is not mutagenic in this bacterial mutation test at any dose level either in the absence or presence of an exogenous metabolic activation system.
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