美國食品藥品監(jiān)督管理局最近提出了監(jiān)管電子霧化裝置上市的PMTA法規(guī),法規(guī)要求在美國上市的電子霧化裝置產品必須審查化學品成份,添加劑,尼古丁濃度,毒理學特征和對人體健康的影響,從而獲得上市許可。同樣,英國的電子霧化裝置制造商或進口商也必須嚴格遵守產品安全法規(guī),對產品成份和釋放物進行毒理學測試,興奮劑、色素和維生素添加劑受到嚴格監(jiān)管,以評估對人體健康的影響。
According to Premarket Tobacco Product Applications (PMTA) For ENDS, FDA requires manufacturers and importers submit testing reports of chemicals, additives, Nicotine concentration, and a full toxicological and pharmacological assessment for health risks of new tobacco products. In EU countries, such as UK, manufacturers and importers of E-Cigarettes also need to submit test reports of components, ingredients, additives, and toxicological assessment, according to EU Tobacco Products Directive (TPD) on E-Cigarettes, to assess the public health risks.
因此,全球電子霧化裝置市場對電子煙產品的監(jiān)管均日趨嚴格,對產品進行毒理學評估成為大勢所趨。天鑒檢測機構以國際認可的加拿大衛(wèi)生部毒理測試為標準,已開發(fā)出完善的電子霧化裝置體外毒理學檢測方法,面向電子霧化裝置各類企業(yè),提供電子霧化裝置煙油及氣溶膠的體外毒理學評估測試服務。
Under the background of more strict supervision of E-Cigarettes marketing in global market, toxicological assessment of ENDS is essential for E-Cigarettes products marketing. As one of the earliest independent testing organizations in E-Cigarettes test field, SKYTE has developed complete in vitro toxicological assessment methods for E-Cigarettes, according to Health Canada official methods.
電子霧化裝置體外毒理學測試內容具體包含:
We can provide E-liquids and aerosol in vitro toxicological assessment services as follows:
主流煙氣樣品的收集。
Preparation and collection of mainstream tobacco smoke for in vitro toxicological assessment.
中性紅試驗:用細胞的半數(shù)致死率來評估受試物毒性。
Neutral Red Uptake Assay. Assess cytotoxicity of test sample by half maximal inhibitory concentration (IC50).
細菌回復突變試驗:用細菌的致突變性來評估受試物毒性。
Bacterial Reverse Mutation Assay (Ames Assay). Assess cytotoxicity of test sample by bacterial mutagenicity.
體外微核試驗:用細胞核微核率來評估受試物毒性的報告。
In Vitro Micronucleus Assay. Assess cytotoxicity of test sample by ratio of micronucleated cells per 1000 observed cells.