【摘 要】
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Regulatory drivers are requiring that alternative methods to animal testing be used in the assessment of cosmetic ingredients and formulations.The threshold of toxicological concern (TTC) is one usefu
【机 构】
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Dow Europe GmbH,Horgen, Switzerland US FDA CFSAN
【出 处】
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2016(第二届)毒性测试替代方法与转化毒理学(国际)学术研讨会暨有害结局路径(AOP)与风险评估培训会议
论文部分内容阅读
Regulatory drivers are requiring that alternative methods to animal testing be used in the assessment of cosmetic ingredients and formulations.The threshold of toxicological concern (TTC) is one useful approach to estimate potential systemic toxicity of compounds with limited toxicology data.The COSMOS consortium within SEURAT-1 has developed a new non-cancer TTC database enriched with cosmetic-related chemicals.The sources of the toxicity data for the TTC database have been primarily of regulatory origin, including EU SCCS, EFSA,US FDA, US EPA along with the technical reports from US National Toxicology Program.This has been augmented with chemicals from the Munro dataset found in Cosmetics Inventories.Studies were selected according to a strict set of inclusion criteria.The resulting TTC database contains information on over 556 chemicals, including NOAELs and critical effects at the LOAELs.Over 25% of the toxicity data were evaluated in four study review sessions by an ILSI Europe Expert Group, including studies for the lowest 10th percentile of NOAELs from each Cramer Class, and studies showing large discrepancies across the data sources.The chemical space of the new TTC database has been compared with that of other existing TTC databases, demonstrating its suitability of coverage for the assessment of cosmetic-related chemicals.Comparing the 5th percentile values of the distributions of NOAELs in the COSMOS TTC database with those from the Munro database showed that existing TTCs values are adequately protective.This abstract does not reflect the policy of US FDA, JRC, or EC.
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