Analysis Of N-nitrosamines In Latex Products And Biosafety Evaluation

Nitrosamines are a family of carcinogenic compounds.Nitrosamines in latex products such as nipples,balloons and condoms have been detected by researchers.In view of their close contact with skin,body fluids and tissues,it is very important to research the release of nitrosamines from natural latex products and to evaluate their potential toxicity.Firstly,nitrosamines migration from latex products were studied in the dissertation:Nitrosamines migration from 37 latex condoms,10 latex gloves,5 latex balloons and 4 sillicon nipples collected from China market were detected by EN12868(Methods for determining the release of N-Nitrosamines from elastomer or rubber teats and soothers) for the first time.The result showed nitrosamines migration from condoms, gloves and balloons were beyond seriously the 93/11/EEC limits.It was established a method to detect the migration of nitrosamines from nature latex gloves for the first time.After the gloves were soaked in artificial sweat for 4h,the nitrosamines were extracted from artificial sweat by dichloromethane and detected by GC-TEA.The method is effective,quick and accurate.NDMA,NDEA and NEBA were found in almost 27 gloves from China market.The total migration of nitrosamines ranged from 18.89 to 244.51μg/kg,which were all above the 93/11/EEC limits.It was established a method to detect the migration of nitrosamines from nature latex condoms.After the condoms were soaked in artificial sweat for 10min,the nitrosamines were extracted from artificial sweat by dichloromethane and detected by GC-TEA.The method is effective,quick and accurate.NDMA,NDEA and NEBA were found in almost 27 condoms from China market.The total migration of nitrosamines ranged from 15.62 to 792.89μg/kg,which were all above the 93/11/EEC limits.Secondly,the biological safety evaluation of latex products and nitrosamines migration from them were studied in the dissertation:The cytotoxic potential of the gloves and condoms collected from China market was evaluated by a MTT assay with a L929 cell line.Extracts from partial gloves and condoms were found to be cytotoxic and there was a positive significant correlation between cytotoxicity and the the release level of nitrosamines.The mutagenicity of migration of nitrosamines from latex gloves and condoms were evaluated by a Salmonella typhimurium mutation assay with the strains TA98, TA97,TA100 and TA102 and by a micronucleus test(MN test) using ICR mice for the first time.The migration level of nitrosamines from glove E05 and condom C02 were Selected to design the doses in two tests to evaluate quantitatively.The high mutagenicity toxicity was found in Ames assay and MN test.An exposure of NDMA,NDEA and NDBA in ICR mice by vaginal administration to observe acute toxicity was undertaken,respectively.The vaginal administration mode, the clinical manifestations and pathomorphological change of tissues and organs was researched preliminarily.