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EC number: 439-840-1
CAS number: 20846-91-7
There was a statistically significant
increase in numerical aberrations (p < 0.025) at 20 and 40 ug/mL in
study 1 and 2, respectively, after 42 h exposure. Although a
statistically significant increase (p < 0.025) was also seen in
structural aberrations in study 2 at 40 ug/mL at this exposure time, the
percentage increase was within the acceptable range of historical
control values, and therefore was considered by the investigators not to
be biologically relevant.
Summary of cytogenetic analysis after 42
h exposure without metabolic activation
In a GLP study, equivalent to OECD Guideline
473, trisodium EDDS was assessed for its ability to induce chromosome
aberrations in Chinese hamster ovary (CHO) cells. CHO cells were
incubated with seven or more dose levels of the test sustance for either
6, 18 or 42 h without S9, or for 6 h with S9. The concentration ranges
were determined on the basis of cytotoxicity studies using the same
exposure times; 5 mg/mL was selected as the highest dose for the 6 and
18 h exposures and 1.25 mg/mL for the 42 h exposure. After a total
incubation period of either 18 or 42 h, cells were fixed and stained and
the three highest doses with 200 scorable metaphases were selected for
evaluation of chromosome aberrations.
A statistically significant increase in
numerical aberrations was evident after an exposure of 42 h without S9.
Although a statistically significant increase was also seen in
structural aberrations at 40 ug/mL at this exposure time, the percentage
increase was within the acceptable range of historical control values,
and therefore was considered by the investigators not to be biologically
relevant. No significant increase in either numerical or structural
aberrations was detected after 6 or 18 h without S9, or after 6 h with
Overall, trisodium EDDS caused chromosome
aberrations in an in vitro mammalian cytogenicity assay.
trisodium EDDS is considered relevant to use for understanding the
potential genotoxicity of EDDS acid, and is acceptable for using as
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