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Toxicological information

Carcinogenicity

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Description of key information

The data from zinc and citric acid will be used to derived data for trizinc dicitrate 
Zinc
(45-53 wk drinking water study) no treatment related tumours mice (Walters and Roe, 1965, cited in the Zinc metal RAR, 2008).
Citric acid
No studies available, however long history of human exposure provides evidence for non-carcinogenicity of citric acid.

Key value for chemical safety assessment

Additional information

The effect of trizinc dicitrate is not expected to differ significantly from the effects of exposure to the zinc ions and citric acid separately once absorbed. Therefore, the assessment of this substance will be based on both citric acid and zinc respectively.

A limited carcinogenicity study where zinc sulphate was administered to mice in drinking water for 45 – 53 weeks, provided no indication of treatment related tumours (Walters and Roe, 1965, cited in the Zinc metal RAR, 2008).

Citric acid

There are no specific carcinogenicity studies with citric acid, however a long history of human exposure together with the absence of any treatment related effects in repeated dose studies mean that it is unlikely that citric acid would be carcinogenic.

Justification for classification or non-classification