Determination of Analytical Detection Limits

Client

ECITA, the Electronic Cigarette Industry Trade Association [written with permission from ECITA]

Background

A number of organic compounds are present in electronic cigarette formulations and these might be inhaled (along with nicotine and other excipients) by the consumer. Many of these compounds (including thermal degradation products) are commonly encountered impurities in such devices, regardless of the formulation, and it therefore seems appropriate to define critical inhalation health criteria values (HCVs; i.e. tolerable daily intake levels) for these compounds. Such values can be used to determine appropriate analytical Limits of Quantification (LOQs). These levels can subsequently be used to inform decisions regarding future electronic cigarette risk assessments if emission estimates (following analytical work) indicate that exposures might exceed the derived LOQ for a particular analyte.

Project goals

To propose an LOQ for each of a number of common electronic cigarette emission analytes, based on extrapolation from existing inhalation HCVs (where available).

Approach

We searched for, collated and critically assessed the key existing HCVs for each analyte, focusing on those values derived for inhalation exposures (irritation and systemic, cancer and non-cancer) of the general population (or appropriate consumer uses). Existing Expert Group reports were used as the basis as far as possible.

Where necessary, occupational exposure limits (OELs) and HCVs from other routes of administration (e.g. oral) were included, with appropriate modifications made. In the absence of existing HCVs, new values were proposed from the existing toxicological dataset (e.g. extrapolation from critical NOAECs/LOAECs using ECHA REACH-DNEL guidance).

Project leader

Richard Young

With thanks to ECITA for allowing us to share this piece of project work in a public domain.

 

E-cigarettes

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