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EC number: 246-467-6
CAS number: 24801-88-5
Gene mutation (Bacterial reverse
mutation assay / Ames test): negative with and without activation in Salmonella
typhimurium strains TA 98, TA 100, TA 1535, TA 1537 and E.coli
WP2 uvrA (similar to OECD TG 471) (BioReliance, 1999).
chromosomal aberration test: negative with metabolic activation and
positive without metabolic activation (according to OECD TG 473)
Table 2: Dose
range-finding study Number
of revertants per plate (2 plates per strain)
Experiment 1 Mutagenicity Assay Number
of revertants per plate (mean of 3 plates)
Experiment 2 Mutagenicity Assay Number
of revertants per plate (mean of 3 plates)
Table 1: Summary: Main Experiment , without and with metabolic activation
Mean aberrant cells
Historical Laboratory Negative Control Range
Without S9 mix,
4 h treatment,
21 h preparation interval
-0.28% - 3.70% aberrant cells excl. gaps
With S9 mix,
-0.23% - 3.95% aberrant cells excl. gaps
C: Negative Control (Culture Medium)
S: Solvent Control (DMSO)
RICC: Relative Increase in Cell Count, calculated by the increase in
cell number of the test groups compared to the solvent control groups.
The cell count was determined by a cell counter per culture for each
a: - without precipitation, + with precipitation
b: statistical significant increase compared to solvent controls
(Fisher’s exact test, p< 0.05), +: significant; -not significant
There are no in vivo
genetic toxicity tests for triethoxy(3-isocyanatopropyl)silane. As the
result of the in vitro cytogenicity study according to the OECD
Test Guideline 473 is a clear positive without metabolic activation,
with an increase in the number of aberrations relative to control which
is statistically significant and dose-dependent, an in vivo comet
assay will be conducted after approval by ECHA.
has been tested according to a protocol that is similar to OECD 471 and
under GLP in Salmonella typhimurium strains TA 98, TA 100, TA
1535 and TA 1537 and E. coli WP2 uvrA (BioReliance, 1999). No
test substance induced increase in the number of revertants was observed
in the presence or absence of metabolic activation when tested up to
cytotoxic concentrations. Appropriate solvent and positive controls were
included and gave expected results. It is concluded that the test
substance is negative for mutagenicity to bacteria under the conditions
of the test.
has been tested for ability to cause chromosome aberrations in Chinese
hamster V79 cells according to OECD Test Guideline 473 and in compliance
with GLP (Eurofins, 2019). No increase in the number of cells with
aberrations was observed with metabolic activation in Chinese hamster
V79 cells. Statistically significant increase in the number of aberrant
cells was observed when tested without metabolic activation. Appropriate
solvent, negative (treatment medium) and positive controls were included
and gave expected results. It is concluded that the test substance is
positive for the induction of chromosome aberrations under the
conditions of this study.
Data for the hydrolysis product, 3-aminopropyl(triethoxy)silane (CAS
919-30-2), have been added to the dataset as supporting information for
completeness, but are not used in the assessment as the parent substance
has reliable data and a testing proposal for a comet assay to
investigate the genetic toxicity potential further.
Insufficient information is
available to conclude on the classification for mutagenicity of
triethoxy(3-isocyanatopropyl)silane according to Regulation (EC)
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