Volatile N-Nitrosamines in Infant Pacifiers Sold in the United States as Determined by Gas Chromatography/Thermal Energy Analysis

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Abstract
Volatile N-nitrosamines in infant latex rubber pacifiers were determined using a modification of a previously described dichloromethane extraction procedure, followed by gas chromatography/thermal energy analysis. Under an interagency agreement between the National Center for Toxicological Research and the Consumer Product Safety Commission (CPSC), data were obtained on the baseline and compliance concentrations of volatile N-nitrosamines in infant pacifiers sold in the United States. Pacifiers made by 18 different manufacturers before and after the January 1, 1984 action level of 60 ppb was set by the CPSC were analyzed for volatile N-nitrosamines. N-Nitrosodibutylamine was the principal N-nitrosamine found, along with trace amounts of N-nitrosodimethylamine, N-nitrosodiethylamine, and N-nitrosopiperidine. Mean total volatile N-nitrosamine levels for baseline and compliance samples were 63.9 and 21.2 ppb, respectively. The pacifier lots sampled after January 1, 1984 showed a significant decrease in contamination levels, indicating that at least 98% of the market share is in compliance with the CPSC enforcement policy for N-nitrosamines in infant pacifiers sold in the United States.