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.
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.