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EC number: 208-901-2
CAS number: 546-46-3
The key acute oral study reports an LD50 value of >2000mg/kg (Safepharm 1991; rel 1). The only available key study for dermal toxicity was read across from citric acid, which reports an LD50 value of 2000mg/kg (Safepharm, 2006; rel 1). Weight of evidence from other zinc metals (zinc distearate and zinc sulphate) support the key findings (EU RAR, 2008; rel 2).
There were no available data for acute dermal toxicity and inhalation
toxicity for trizinc dicitrate. The data for inhalation toxicity is
waived, since reliable read across is available via the dermal route and
a key study is present for acute oral toxicity for trizinc dicitrate.
The existing key data read across from citric acid indicates that the
citrate is not acutely toxic following dermal exposure. Limited data for
acute dermal toxicity are available for other zinc salts. However, the
EU risk assessment Report (RAR) for zinc sulphate (EU 2004) reports an
acute dermal LD50 value of >2000 mg/kg for rats treated with zinc
sulphate heptahydrate, and the RAR for zinc distearate (EU 2008) also
reports LD50 (rat, dermal) >2000 mg/kg. No details are available
regarding the study with distearate. For zinc sulphate heptahydrate,
local signs of irritation were reported, but there was no evidence of
systemic toxicity reported in the RAR.
The LD50 value of >2000 mg/kg for ZnSO4x7H20/kg bw was converted into
trizinc dicitrate in the following steps:
2000x0.18*= >360 mg Zn/kg bw
369x2.9** = >1070 mg trizinc dicitrate/kg bw
the conversion factors are obtained by taking into consideration the MW
of the substance:
*the conversion from ZnSO4x7H20 into Zn is: MW Zn/MW
**the conversion from Zn to trizinc dicitrate is: MW trizinc dicitrate /
(MW Zinc*3)=547 / (65*3)= 2.9
The LD50 value, when converted into trizinc dicitrate is therefore
>1070mg/kg bw, which alone is not sufficient for classification
purposes. The conversion of the result from zinc distearate into trizinc
dicitrate yields a lower value than zinc sulphate. It is therefore
unlikely that a limit test on trizincdicitrate itself would yield an
LD50 above classification cut off point. Furthermore, the LogKow of <0
of trizinc dicitrate indicates that dermal uptake is unlikely. Based on
the evidence available from citric acid and the other zinc compounds,
together with the physico chemical properties of trizinc dicitrate it is
therefore concluded that toxicity of the test substance via the dermal
route is likely to be low.
The data available for other zinc compounds indicating low acute dermal
toxicity/no classification, the physico chemical properties of trizinc
dicitrate and the lack of classification of citric acid make classification
or labelling to be an unlikely requirement for the acute dermal
toxicity for trizinc dicitrate. The acute oral toxicity data for trizinc
dicitrate do not trigger classification in accordance with current EU
Directive 67/548/EEC or Regulation 1272/2008.
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