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    SEP 2018
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How low can you go? An analysis of lowest effective dose in the Ames test.

pdf fileKocks G; Williams RV; Tate M;

Non-intentionally added substances (NIAS) are a challenge for the food contact materials industry. European framework regulation (EU 1935/2004, Article 3), states suppliers have to guarantee the safety of the final product. However, the risk assessment of NIAS has proven difficult due partly to questions regarding the sensitivity of test methods, potency and the small amount of migrate produced for toxicological testing. Thus, the question is whether conventional genotoxicity assays are sufficiently sensitive to detect toxicity at very low doses.

Publicly available Ames test dose response data for more than 1,500 substances has been collated from the Vitic database. Data analytics has been applied to determine the lowest dose at which a mutagenic response could be detected. This was found to be 0.01 ug/plate for this data set, although in many cases that also equated to the lowest tested dose. 


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