Discriminatory power of standard toxicity assays used to evaluate ingredients added to cigarettes

Oldham, Michael J.; Haussmann, Hans-Juergen; Gomm, Willy; Rimmer, Lonnie; Morton, Michael J.; McKinney, William T.

doi:10.1016/j.yrtph.2011.11.018

Cited by 23 publications

(6 citation statements)

References 30 publications

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“…For each of the constituents above the limit of quantification (LOQ) in the 3R4F monitor test piece reference data set, the critical differences for differences of means of two single point in time measurements between 3R4F and 1R6F are defined to be [59]:Critical difference, CD[]%= 3*2*RSD[]%*1nwhere RSD[%] stands for the relative standard deviation in percent of the 3R4F monitor data set for the given constituent, and n = number of replicates (i.e., four replicates, as per the sample testing scheme). The performance of the 3R4F and 1R6F reference cigarettes are deemed comparable if the absolute percentage differences per constituent are within the performance boundaries expressed by the critical differences.…”

Section: Methodsmentioning

confidence: 99%

Mainstream smoke constituents and in vitro toxicity comparative analysis of 3R4F and 1R6F reference cigarettes

et al. 2019

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Section: Methodsmentioning

confidence: 99%

Mainstream smoke constituents and in vitro toxicity comparative analysis of 3R4F and 1R6F reference cigarettes

et al. 2019

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“…The comparison of 1R6F and 3R4F was performed based on the critical difference (CD) calculated using 3R4F data variations. The CD value is equivalent to discriminatory power, which is the smallest statistically significant difference that can be detected with an assay based on the variability of data with the significance level of α = 0.05 (40). The range of CD values of 3R4F has been previously described ( 12);…”

Section: Discussionmentioning

confidence: 99%

Inter-Laboratory Reproducibility and Interchangeability of 3R4F and 1R6F Reference Cigarettes in Mainstream Smoke Chemical Analysis and In Vitro Toxicity Assays

Sakai

Mori

Yanagimachi

et al. 2020

Contributions to Tobacco &Amp; Nicotine Research

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Summary A new reference cigarette, 1R6F, produced by the Kentucky Tobacco Research and Development Center, has been manufactured as a substitute for the 3R4F reference cigarette because of a depletion of 3R4F stock. The purpose of the current study was to investigate the interchangeability of 1R6F and 3R4F by comparing the chemical and biological characteristics of the mainstream smoke and to assess the inter-laboratory reproducibility by comparing the results obtained in the current study with a previous report. We analyzed 45 priority chemicals required by Health Canada for regulatory reporting and assessed the toxicological effects of cigarette smoke using in vitro standard toxicological assays recommended by the Cooperation Centre for Scientific Research Relative to Tobacco (CORESTA) under the International Organization for Standardization (ISO) standard and intense smoking regimens. The results of the chemical analysis and standard toxicological assays showed a good inter-laboratory reproducibility for 1R6F as a reference cigarette, while there were some slight reproducible differences between 1R6F and 3R4F. In addition, we investigated the interchangeability of 1R6F with 3R4F in some additional toxicological assays that detect oxidative stress because oxidative stress is a principle endpoint used in tobacco research with next generation tobacco and nicotine delivery products (NGPs). Both 1R6F and 3R4F elicited comparable responses in the oxidative stress assays. Overall, our results showed inter-laboratory reproducibility in chemical and standard toxicological assessments of 1R6F; thus, suggesting the suitability of 1R6F as a reference cigarette. In addition, the results obtained in the oxidative stress assays provide insight into the interchangeability of 1R6F with 3R4F when used as a comparator for NGPs.

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“…Results of a t -test for differences of the yields are presented. However, several limitations of the t -test applied to smoke constituent yield data have been discussed. − In particular, small numbers of replicates may lead to an overestimation of variability; thus, no difference might be observed in the presence of one; conversely, variability of both production and analytical methods has been shown to result in apparent differences between two smoke constituent yield determinations for the same cigarette sample.…”

Section: Methodsmentioning

confidence: 99%

Menthol Addition to Cigarettes Using Breakable Capsules in the Filter. Impact on the Mainstream Smoke Yields of the Health Canada List Constituents

Dolka

Piadé

Belushkin

et al. 2013

Chem. Res. Toxicol.

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Cigarettes with menthol capsules embedded in the filter have been introduced recently in many countries. At the same time, concerns have been expressed that filter performance could be affected by the crushing of the capsule therein, altering mainstream smoke constituent yields, ultimately with the potential to impact the toxicity of these products. The present study investigates the possible mechanisms underlying differences in smoke constituent deliveries following the crushing of a menthol capsule in a cigarette filter. It also includes results from a market survey of a selection of commercial cigarette brands with menthol capsules representing the different designs for this type of product available in different markets worldwide. The yields of 46 Health Canada smoke components were determined according to the International Organization for Standardization (ISO) machine-smoking regime. Data obtained from measurements using cigarettes with the capsule crushed and uncrushed were compared. Except for the intended presence of menthol flavors in smoke, no meaningful differences were identified in the yields of the remaining measured particulate-phase smoke constituents. Regarding the gas-phase smoke constituents, it was found that the delivery of lipophilic volatiles was reduced when the capsule was crushed. Delivery of the other measured gas-phase components remained unaffected. The results from investigations performed in this study did not show any meaningful increase in the yield of smoke constituents listed by Health Canada as a result of crushing the menthol capsule in the cigarette filter.

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Discriminatory power of standard toxicity assays used to evaluate ingredients added to cigarettes

Cited by 23 publications

References 30 publications

Mainstream smoke constituents and in vitro toxicity comparative analysis of 3R4F and 1R6F reference cigarettes

Mainstream smoke constituents and in vitro toxicity comparative analysis of 3R4F and 1R6F reference cigarettes

Inter-Laboratory Reproducibility and Interchangeability of 3R4F and 1R6F Reference Cigarettes in Mainstream Smoke Chemical Analysis and In Vitro Toxicity Assays

Menthol Addition to Cigarettes Using Breakable Capsules in the Filter. Impact on the Mainstream Smoke Yields of the Health Canada List Constituents

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