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EC number: 263-503-6
CAS number: 62314-25-4
In an in vitro gene mutation study in mammalian cells (mouse lymphoma
assay) the test item, Hydroxypropyl, 2-, trimethylammonium formate did
not induce any increases in the mutant frequency at the TK +/- locus in
L5178Y cells that exceeded the Global Evaluation Factor (GEF) of 126 x
10-6, consequently it is considered to be non-mutagenic.
In an in vitro cytogenicity / chromosome aberration study in mammalian
cells (human peripheral blood lymphocytes) Hydroxypropyl, 2-,
trimethylammonium formate was non-toxic to human lymphocytes and did not
induce any statistically significant increases in the frequency of cells
with aberrations, using a dose range that included a dose level that was
the maximum recommended dose level. The test item, Hydroxypropyl, 2-,
trimethylammonium formate was considered to be non-clastogenic to human
lymphocytes in vitro.
Duplicate cultures of human lymphocytes, treated with the test item,
were evaluated for chromosome aberratios at three dose levels, together
with vehicle and positive controls. In this study, three exposure
conditions were investigated; 4 hours exposure in the presence of
an induced rat liver homogenate metabolizing system (S9), at a 2% final
concentration with cell harvest after a 20-hour expression period, 4
hours exposure in the absence of metabolic activation (S9) with a
20-hour expression period and a 24-hour exposure in the absence of
metabolic activation. The dose levels used in the Main Experiment were
selected using data from the preliminary toxicity test where the results
indicated that the maximum concentration was the maximum recommended
All vehicle (Eagle's minimal essential medium with HEPES buffer (MEM))
controls had frequencies of cells with aberrations within the range
expected for normal human lymphocytes.
All the positive control items induced statistically significant
increases in the frequency of cells with aberrations. Thus, the
sensitivity of the assay and the efficacy of the S9-mix were validated.
The test item was non-toxic to human lymphocytes and did not induce any
statistically significant increases in the frequency of cells with
aberrations, using a dose range that included a dose level that was the
maximum recommended dose level.
The test item, Hydroxypropyl, 2-, trimethylammonium formate was
considered to be non-clastogenic to human lymphocytes in vitro.
The study was conducted according to a method that was designed to
assess the potential mutagenicity of the test item on the thymidine
kinase, TK +/-, locus of the L5178Y mouse lymphoma cell line. The method
was designed to be compatible with the OECD Guidelines for Testing of
Chemicals No 490 "In Vitro Mammalian Cell Gene Mutation Tests Using the
Thymidine Kinase Gene" adopted 29 July 2016, Method B17 of Commission
Regulation (EC) No. 440/2008 of 30 May 2008, the US EPA OPPTS 870.5300
Guideline, and in alignment with the Japanese MITI/MHW guidelines for
testing of new chemical substances.
One main Mutagenicity Test was performed. In this main test, L5178Y TK
+/- 3.7.2c mouse lymphoma cells (heterozygous at the thymidine kinase
locus) were treated with the test item at 8 dose levels in duplicate,
together with vehicle (RO media), and positive controls using 4-hour
exposure groups both in the absence and presence of metabolic activation
(2% S9), and a 24-hour exposure group in the absence of metabolic
activation. The dose range of test item used in the main test was
selected following the results of a preliminary toxicity test. The test
item did not exhibit any marked toxicity in either of the 4- hour
exposure groups. In the 24-hour exposure group moderate levels of test
item induced toxicity can observed at the upper dose levels. No
precipitate of the test item was observed in any of the exposure groups.
Therefore the test item could be tested up the maximum recommended 10mM
dose level in the main test.
The maximum dose level used was the maximum recommended dose level
(approximately 10mM) of 1632 µg/mL. No precipitate of the test item was
observed throughout. The vehicle control cultures had mutant frequency
values that were acceptable for the L5178Y cell line at the TK +/-
locus. The positive control substances induced marked increases in the
mutant frequency, sufficient to indicate the satisfactory performance of
the test and of the activity of the metabolizing system.
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