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EC number: 208-901-2
CAS number: 546-46-3
(13 wk) NOAEL 234 mg ZnSO4.7H2O/kg bw rats (approximately 53.5 mg
Zn2+/kg bw or 155 mg trizinc dicitrate/kg (bw)*) (Maita et al., 1981;
(13 wk) NOAEL = 469 mg ZnSO4.7H2O/kg bw rats (approximately 104 mg
Zn2+/kg bw or 302 mg trizinc dicitrate/kg (bw)*). (Maita et al., 1981,
(5 d) NOAEL 4000 mg/kg, rats (Bachtold1976; rel 2)
(10 d) NOAEL (mortality) values of 1000 and 4000 mg/kg, mice and rats
respectively (Bachtold 1978, rel. 2)
For DNEL derivation human data (listed under IUCLID chapter 7.10.3) are
used with a 10 week NOAEL of approx. 50 mg Zn2 +/person/d based on a
depressed copper uptake and an altered lipid profile in humans.
This section contains substantially new data.
most of the available test data for citric acid does not match current
testing standards (due to short testing duration, or insufficient
information, etc), it does indicate low acute toxicity following repeat
dose exposure.For example, a reliable five day study in rats gave NAOEL
value of 4000 mg/kg (Bachtold, 1976; rel 2); a 10 day study in mice and
rats gave NOAEL (mortality) values of 1000 mg/kg and 4000 mg/kg
respectively (Bachtold, 1978;rel 2).
effect of trizinc dicitrate is not expected to differ significantly from
the effects of the zinc ions and citric acid separately once
absorbedtherefore the assessment of this substance will be based on both
citric acid and zinc respectively. Since the toxicological effects of
citric acid are negligible, the effects of trizinc dicitrate are derived
from a 13 week reliable screening repeat dose/reproduction feeding study
in rats with zinc sulphate reported aNOAEL of 234
bw (approximately 53.5 mg Zn2+/kg bw or 155
mg trizinc dicitrate/kg (bw)*), and in mice a NOAEL of 469
bw. (Which approximates to 104 mg Zn2+/kg bw or 302 mg trizinc
dicitrate/kg (bw)*). (Maita
et al, 1981).
study in rats with zinc monoglycerolate reported a NOAEL = 31.52 mg zinc
monoglycerolate/kg bw. This correlates to a NOAEL ~ 13.26 mg Zn2+/kg
bw or 38.45 mg trizinc dicitrate/kg (bw)*).(Edwards and Buckley, 1995,
Zinc chloride RAR 2008).
DNEL derivation human data (listed under IUCLID chapter 7.10.3) are used
with a 10 week NOAEL of approx. 50 mg Zn2 +/person/d based on a
depressed copper uptake and an altered lipid profile in humans, which is
in line with existing evaluation like EFSA, EU and MAK commission.
information is considered as substantial new information compared to the
study results from animal studies.
zinc RAR have been reviewed and the data contained is identical to that
which has been detailed here.
factor = (MW trizinc dicitrate / (MW Zinc x 3) = 547 / (65x3) = 2.9)
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