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EC number: 237-864-5
CAS number: 14025-15-1
EDTA-CuNa2 was negative in the Ames test and
in the in vitro micronucleus test using a treatment period of 4 h (with
and without S9 -mix). In the in vitro micronucleus test using a
treatment period of 20 h (continuous treatment without S9 -mix),
EDTA-CuNa2 was positive at levels >= 62.5 µg/mL, inducing aneugenic but
no clastogenic effects. This long treatment period together with the
high concentrations of chelant may have resulted in exchange and
substantial binding of essential elements such as zinc. Similar results
were obtained with EDTA-FeNa and DTPA-FeNaH (see robust summaries and
read across document; section 13). Heimbach et al (2000; see also robust
summary) concluded that the lack of effects by the Zn-EDTA salt in
contrast to effects induced by Ca-, Na- and Mn-salts of EDTA, provided
evidence that zinc is required for the initiation or continuation of DNA
synthesis and maintaining cell function. As such, the significance of
mutations produced by EDTA-CuNa2 (and also EDTA-FeNa and DTPA-FeNaH) at
non-physiological concentrations in an in vitro screening system is
difficult to extrapolate for relevance to intact organisms.
Although no in vivo genotoxicity studies
have been carried out with EDTA-CuNa2, several in vivo genotoxicity
studies are available for other EDTA-compounds such as EDTA-Na2H2. No
genotoxic activity was observed (see also read across document in
Therefore, the overall findings indicate
that EDTA-CuNa2 lacks significant genotoxic potential under conditions
that do not deplete essential trace elements required for normal cell
The test substance gave negative results in
two in vitro mutagenicity studies, viz. the Ames test and the
micronuclueus test following exposure for 4 h (with and without S9 mix)
but gave positive results (aneugenicity but not clastogenicity )
following exposure for 20 h (without S9 -mix). The latter was most
probably explained by induction of Zn deficiency. Overall, it was
concluded that classification for genotoxicity is not warranted.
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