Single-use chemical breathalyzer: What are the risks?
The requirement to carry single-use chemical breathalyzers in all motor vehicles on land as of July 1, 2012 (Decree No. 2012-284 of February 28, 2012) prompted the Directorate General for Health to commission the French Institute for Public Health Surveillance to conduct a study of cases of exposure to single-use breathalyzers reported to poison control and toxicovigilance centers (CAPTV), to analyze the circumstances surrounding these poisonings, and to summarize the expected adverse effects given the composition of these breathalyzers. Case description. A survey was conducted on cases of exposure to a breathalyzer reported to the CAPTVs between January 1, 1999, and June 10, 2012, and recorded in their information system. The analysis identified 156 cases of exposure. The number of cases increased over time; this could be linked to campaigns recommending self-testing for blood alcohol concentration before driving a vehicle. Apart from the cases expected among the adult driving population, the analysis highlighted two specific groups: accidental exposure among children (ages 1–4) and young adults targeted by self-testing (leaving nightclubs; age at first driver’s license). Two main circumstances of exposure were identified. In four cases, the device was bitten and/or swallowed while the individual was in a state of advanced intoxication; two of these were considered significant, one involving erosion of the buccal mucosa and the other involving isolated esophagitis of limited intensity and topography. All 152 other cases, most following accidental exposure, were subjected to a comprehensive analysis. Apart from the cases expected in the adult population, the age distribution highlighted two specific groups: accidental exposure in children (ages 1–4) and young adults engaging in self-medication (leaving a nightclub; driving age). In four cases, the device had been bitten and/or swallowed while the individual was heavily intoxicated. The remaining 152 cases mostly occurred following accidental exposure. Three-quarters of them (n=119) were symptomatic. They most often resulted from oral exposure (66%, n=79) and, in these instances, primarily presented with mild signs of irritation of the digestive mucosa. Twenty-four percent of cases (n=28) resulted from ocular exposure (24%, n=28); all of these cases were symptomatic, with one of them, a case of keratitis, being of moderate severity. A specific exposure scenario was noted in 13 cases: oral contact with a device that had degraded and become contaminated with liquid, possibly due to storage conditions. This risk of degradation could be included in the information provided to the public about the device or in its package insert (not to be confused with the test’s operating conditions). Breathalyzers and their compositions. The breathalyzer involved in these exposures was specifically identified in 35 cases. For the other cases, a generic code was used (“Alcootest / breathalyzer”). For the hazard analysis, information regarding breathalyzers was gathered from the compositions available in the composition database, the list of single-use breathalyzers published by the National Metrology and Testing Laboratory (LNE), information provided by manufacturers or distributors, or information available on the Internet. The main potential adverse effects were summarized based on key reference works, safety data sheets produced by the National Institute for Research and Safety, and consultation of international organization websites. These breathalyzers consist of a reagent tube containing primarily silica in the form of crystals or gel, sulfuric acid, and a chromium salt. In the presence of ethanol, orange hexavalent chromium is converted into green trivalent chromium. The presence of other breathalyzers with different compositions could nevertheless have been masked by generic labeling. Additional research was therefore conducted to identify chromium-free devices: three devices were identified, all from the same Czech manufacturer. For two of them, the composition is precisely known; it primarily involves silica gel, sulfuric acid, (white in color) / iodine (violet vapor). These breathalyzers are not mentioned on the LNE list and are not approved under the NF standard. Potential harmful effects. The probabilities of the various effects occurring cannot be estimated based on the current data. Given their composition, the main potential harmful effects identified are: - irritative/corrosive effects due to chromium derivatives but more likely to the sulfuric acid present in high concentrations. These effects were documented in this study, notably including ulceration of the buccal mucosa in one case and moderate esophagitis in another, occurring after ingestion under very specific circumstances of intoxication. Under more typical exposure conditions, the target site was the ocular mucosa (1 case with keratitis). These local effects can be minimized through decontamination measures, particularly by immediately washing the skin and mucous membranes with water for 15 minutes. In the event of ingestion, according to the opinion of the working group’s toxicologists, and given the minimal quantities involved, drinking a glass of water even before consulting a poison control center could be included in the information provided on the device’s package insert; - Systemic effects are unlikely following ingestion of chromium, potassium iodide, or potassium nitrate, given the small quantities involved. The latter two components are also used elsewhere: the first therapeutically to saturate the thyroid following a nuclear accident, and the second in small quantities as a food additive; - sensitization to hexavalent chromium derivatives; this effect depends mainly on contact time; contact time is reduced in these accidental circumstances, especially when decontamination is carried out quickly; - effects covered by CMR regulations, in particular the carcinogenicity of hexavalent chromium derivatives, The study of cases reported to CAPTV cannot capture these effects, as only cases of acute exposure are included in this study: single, very short-term exposure—particularly if decontamination measures are implemented quickly—to small amounts of chromium. The effects targeted by the CMR classification, and in particular carcinogenicity, biologically fall within the range of prolonged and repeated exposures, which are very different from the circumstances documented in this study. However, according to European regulations, carcinogens in categories 1A and 1B must have a concentration of less than 0.1% by weight of the mixture when it is intended for non-professional use; however, since nothing is specified for articles (i.e., chemical breathalyzers) and the reagent is, under normal storage and use conditions, presumed to be inaccessible. This point may warrant legal analysis. (R.A.)
Author(s): Manel J, Saviuc P, Solal C, de Bels F
Publishing year: 2012
Pages: 21 p.
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