Potential harmful health effects of inhaling nicotine-free shisha-pen vapor: a chemical risk assessment of the main components propylene glycol and glycerol

Background A shisha-pen is an electronic cigarette variant that is advertised to mimic the taste of a water pipe, or shisha. The aim of this study was to assess the potential harmful health effects caused by inhaling the vapor of a nicotine-free shisha-pen. Methods Gas chromatography analysis was performed to determine the major components in shisha-pen vapor. Risk assessment was performed using puff volumes of e-cigarettes and “normal” cigarettes and a 1-puff scenario (one-time exposure). The concentrations that reached the airways and lungs after using a shisha-pen were calculated and compared to data from published toxicity studies. Results The main components in shisha-pen vapor are propylene glycol and glycerol (54%/46%). One puff (50 to 70 mL) results in exposure of propylene glycol and glycerol of 430 to 603 mg/m3 and 348 to 495 mg/m3, respectively. These exposure concentrations were higher than the points of departure for airway irritation based on a human study (propylene glycol, mean concentration of 309 mg/m3) and a rat study (glycerol, no-observed adverse effect level of 165 mg/m3). Conclusions Already after one puff of the shisha-pen, the concentrations of propylene glycol and glycerol are sufficiently high to potentially cause irritation of the airways. New products such as the shisha-pen should be detected and risks should be assessed to inform regulatory actions aimed at limiting potential harm that may be caused to consumers and protecting young people to take up smoking

Fish embryo toxicity test, threshold approach, and moribund as approaches to implement 3R principles to the acute fish toxicity test.

The acute fish toxicity test (AFT) is requested by EU legal frameworks for hazard classification and risk assessment. AFT is one of the few regulatory required tests using death as an endpoint. This paper reviews efforts made to reduce, refine and replace (3Rs) AFT. We make an inventory of information requirements for AFT, summarize studies on 3Rs of AFT and give recommendations. The fish embryo toxicity test (FET) is proposed as a replacement of AFT and analyses have focused on two aspects: assessing the capacity of FET in predicting AFT and defining the applicability domain of FET. Six comparison studies have consistently shown a strong correlation of FET and AFT. In contrast, the applicability domain of FET has not yet been fully defined. FET has not yet been accepted as a replacement of AFT by any EU legal frameworks to fulfill information requirements because FET is insensitive to some chemicals. It is recommended that the outlier chemicals that do not correlate between FET and AFT should be further investigated. When necessary, additional FET data should be generated. Another effort to reduce and refine AFT is incorporation of FET into the threshold approach. Furthermore, moribund as an endpoint of fish death has been introduced in revising AFT guideline to reduce the duration of suffering for refinement. This endpoint, however, needs further work on the link of moribund and death. Global regulatory acceptance of the moribund endpoint would be critical for this development

The effectiveness of an outpatient Acceptance and Commitment Therapy Group programme for a transdiagnostic population

Background: Although a growing number of studies have demonstrated the efficacy of Acceptance and Commitment Therapy (ACT) for the treatment of psychological disorders, the effectiveness of transdiagnostic group ACT programmes in an applied clinical setting requires further evaluation. Methods: The current study examined the effectiveness of a 10‐week ACT transdiagnostic group programme delivered in a private psychiatric hospital. Pre‐ and post‐treatment outcomes were measured in 55 adults presenting with various psychiatric diagnoses. Treatment processes were also analysed. Results: At post‐intervention, participants demonstrated significantly greater valued living, cognitive defusion, and acceptance. No significant differences were evident in participants' mindfulness. Significant improvements were also evident on depression, anxiety, stress, functional disability, satisfaction with life, and personal well‐being. Reliable change indices were also calculated and revealed reliable improvements in a range of outcomes for 27% to 46% of participants. Participant attendance rates, clinician adherence to the manualised ACT content, and patient satisfaction were all high. Conclusions: Collectively, results provided support for the effectiveness of ACT in increasing psychological flexibility and improving psychological symptoms in a transdiagnostic population. However, the current study also showed that many patients did not respond to the intervention and further research is recommended to ascertain predictors of treatment response

Website Use and Effects of Online Information About Tobacco Additives Among the Dutch General Population: A Randomized Controlled Trial

Background As a legal obligation, the Dutch government publishes online information about tobacco additives to make sure that it is publicly available. Little is known about the influence this website (tabakinfo) has on visitors and how the website is evaluated by them. Objective This study assesses how visitors use the website and its effect on their knowledge, risk perception, attitude, and smoking behavior. The study will also assess how the website is evaluated by visitors using a sample of the Dutch general population, including smokers and nonsmokers. Methods A randomized controlled trial was conducted, recruiting participants from an online panel. At baseline, participants (N=672) were asked to fill out an online questionnaire about tobacco additives. Next, participants were randomly allocated to either one of two experimental groups and invited to visit the website providing information about tobacco additives (either with or without a database containing product-specific information) or to a control group that had no access to the website. After 3 months, follow-up measurements took place. Results At follow-up (n=492), no statistically significant differences were found for knowledge, risk perception, attitude, or smoking behavior between the intervention and control groups. Website visits were positively related to younger participants (B=-0.07, 95% CI -0.12 to -0.01; t(11)=-2.43, P=.02) and having a low risk perception toward tobacco additives (B=-0.32, 95% CI -0.63 to -0.02; t(11)=-2.07, P=.04). In comparison, having a lower education (B=-0.67, 95% CI -1.14 to -0.17; t(11)=-2.65, P=.01) was a significant predictor for making less use of the website. Furthermore, the website was evaluated less positively by smokers compared to nonsmokers (t(324)=-3.55, P<.001), and males compared to females (t(324)=-2.21, P=.02). Conclusions The website did not change perceptions of tobacco additives or smoking behavior. Further research is necessary to find out how online information can be used to effectively communication about the risks of tobacco additives

Applicability of generic PBK modelling in chemical hazard assessment: A case study with IndusChemFate.

Toxicology is moving away from animal testing towards in vitro tools to assess chemical safety. This new testing framework requires a quantitative method, i.e. kinetic modelling, which extrapolates effective concentrations in vitro to a bioequivalent human dose in vivo and which can be applied on “high throughput screening” of a wide variety of chemicals. Generic physiologically based kinetic (PBK) models help account for the role of toxicokinetics in setting human toxic exposure levels. Furthermore these models may be parameterized only on in silico QSARs and in vitro metabolism assays, thereby circumventing the use of in vivo toxicokinetics for this purpose. Though several such models exist their applicability domains have yet to be comprehensively assessed. This study extends previous evaluations of the PBK model IndusChemFate and compares it with its more complex biological complement (“TNO Model”). Both models were evaluated with a broad span of chemicals, varying regarding physicochemical properties. The results reveal that the “simpler” performed best, illustrating that IndusChemFate can be a useful first-tier for simulating toxicokinetics based on QSARs and in vitro parameters. Finally, proper quantitative in vitro to in vivo extrapolation conditions were illustrated starting with acetaminophen induced in vitro cytotoxicity in human HepaRG cells