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. 2023 Jan 17;21(1):e07728. doi: 10.2903/j.efsa.2023.7728
Lines of Evidence Influence on conclusion
Line of Evidence 1 – Hepatic copper sequestration at this exposure level is very unlikely as per previous assessment question ↓↓
Line of Evidence 2 – There is no evidence of copper toxicity in the absence of long‐term (chronic) hepatic copper accumulation ↓↓
Line of Evidence 3 – Triggers of copper release from the liver in WD patients are variable and unpredictable, both in nature and timing ?
Line of Evidence 4 – Interindividual variability of copper kinetics, absorption and excretion, in the population ?
Line of Evidence 5 – Although there are no toxicity data available for the population of ATP7B gene variant heterozygotes, the propensity of increased copper retention in the liver compared to the general population, indicates potential increased susceptibility of this subpopulation to future copper‐mediated toxicity
Line of Evidence 6 – Given maternal homeostatic mechanisms, pregnant and lactating women are at no greater risk of toxicity from copper than other women
Conclusion – based on a process of weighing the influence of the different lines of evidence, their consistency and semi‐formal expert judgement, the overall evidence does not support the premise that copper exposure up to 0.07 mg/kg bw per day leads to copper toxicity. Very unlikely (5–10% probability)