The use of Genomic Allergen Rapid Detection (GARD) assays to predict the respiratory and skin sensitising potential of e-liquids

Stevenson, Matthew; Czekala, Lukasz; Simms, Liam; Tschierske, Nicole; Larne, Olivia; Walele, Tanvir

doi:10.1016/j.yrtph.2019.01.001

Cited by 10 publications

(9 citation statements)

References 41 publications

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“…They were approximately 23-fold higher than those following incubation with 3R4F CS TPM with reference to their nicotine concentrations. Our observation, however, was different from that reported earlier (Stevenson et al 2019), showing that the addition of flavors (of other brands) increased the cytotoxicity of the base e-liquids when measured using the human myeloid leukemia-derived cell line. We noted that in that study, the commercial e-liquids were not directly compared with each corresponding base e-liquid (i.e., the commercial formulations were merely tested along with other formulations that do not contain flavors, regardless of whether the concentrations of PG, VG, or nicotine were similar).…”

Section: Discussioncontrasting

confidence: 99%

“…In addition, the e-liquids tested and the cell model used in that study were also different from what we used here. These aspects could likely explain the discrepancy between the results reported here and those in the earlier study (Stevenson et al 2019).…”

Section: Discussioncontrasting

confidence: 99%

“…A later proposal recommended the selection of ingredients based on their potential respiratory allergens (Costigan and Lopez-Belmonte 2017). Finally, a recent article suggested the use of Genomic Allergen Rapid Detection to classify and differentiate flavors based on their sensitizing potentials (Stevenson et al 2019). In addition, our group has proposed a multi-layer systems toxicology framework for in vitro assessment of e-liquids that is meant to complement the battery of classical assays for mutagenicity and genotoxicity testing (Iskandar et al 2016).…”

Section: Introductionmentioning

confidence: 99%

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Application of a multi-layer systems toxicology framework for in vitro assessment of the biological effects of Classic Tobacco e-liquid and its corresponding aerosol using an e-cigarette device with MESH™ technology

et al. 2019

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We previously proposed a systems toxicology framework for in vitro assessment of e-liquids. The framework starts with the first layer aimed at screening the potential toxicity of e-liquids, followed by the second layer aimed at investigating the toxicity-related mechanism of e-liquids, and finally, the third layer aimed at evaluating the toxicity-related mechanism of the corresponding aerosols. In this work, we applied this framework to assess the impact of the e-liquid MESH Classic Tobacco and its aerosol compared with that of cigarette smoke (CS) from the 3R4F reference cigarette. In the first layer, we evaluated the cytotoxicity profile of the MESH Classic Tobacco e-liquid (containing humectants, nicotine, and flavors) and its Base e-liquid (containing humectant and nicotine only) in comparison with total particulate matter (TPM) of 3R4F CS using primary bronchial epithelial cell cultures. In the second layer, the same culture model was used to explore changes in specific markers using high-content screening assays to identify potential toxicity-related mechanisms induced by the MESH Classic Tobacco and Base e-liquids beyond cell viability in comparison with the 3R4F CS TPM-induced effects. Finally, in the third layer, we compared the impact of exposure to the MESH Classic Tobacco or Base aerosols with 3R4F CS using human organotypic air-liquid interface buccal and small airway epithelial cultures. The results showed that the cytotoxicity of the MESH Classic Tobacco liquid was similar to the Base liquid but lower than 3R4F CS TPM at comparable nicotine concentrations. Relative to 3R4F CS exposure, MESH Classic Tobacco aerosol exposure did not cause tissue damage and elicited lower changes in the mRNA, microRNA, and protein markers. In the context of tobacco harm reduction strategy, the framework is suitable to assess the potential-reduced impact of electronic cigarette aerosol relative to CS.

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Section: Discussioncontrasting

confidence: 99%

Section: Discussioncontrasting

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Application of a multi-layer systems toxicology framework for in vitro assessment of the biological effects of Classic Tobacco e-liquid and its corresponding aerosol using an e-cigarette device with MESH™ technology

et al. 2019

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“…Until now, there are still many researchers endeavoring to improve the accuracy of in vitro assay for assessing the skin sensitization potential such as finding new biomarkers for predicting skin sensitization ( Hirota and Moro, 2006 ) or developing a novel assay like Genomic Allergen Rapid Detection (GARD™) to define the skin sensitization activity by only one assay ( Roberts, 2018 ). GARD™ depends on the changes of the gene expression when myeloid cells are exposed to the chemicals ( Johansson et al, 2013 ; Johansson et al, 2019 ; Johansson et al, 2011 ; Roberts, 2018 ; Stevenson et al, 2019 ). This method was validated by numerous laboratories with an inter-laboratory reproducibility of 92.0% in 2019 ( Johansson et al, 2019 ), and has been under the peer-review process for EURL ECVAM validation, which has been announced at https://tsar.jrc.ec.europa.eu/ .…”

Section: Skin Sensitization Assaymentioning

confidence: 99%

In silico Prediction of Skin Sensitization: Quo vadis?

Weng²,

Leong

2021

Front. Pharmacol.

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Skin direct contact with chemical or physical substances is predisposed to allergic contact dermatitis (ACD), producing various allergic reactions, namely rash, blister, or itchy, in the contacted skin area. ACD can be triggered by various extremely complicated adverse outcome pathways (AOPs) remains to be causal for biosafety warrant. As such, commercial products such as ointments or cosmetics can fulfill the topically safe requirements in animal and non-animal models including allergy. Europe, nevertheless, has banned animal tests for the safety evaluations of cosmetic ingredients since 2013, followed by other countries. A variety of non-animal in vitro tests addressing different key events of the AOP, the direct peptide reactivity assay (DPRA), KeratinoSens™, LuSens and human cell line activation test h-CLAT and U-SENS™ have been developed and were adopted in OECD test guideline to identify the skin sensitizers. Other methods, such as the SENS-IS are not yet fully validated and regulatorily accepted. A broad spectrum of in silico models, alternatively, to predict skin sensitization have emerged based on various animal and non-animal data using assorted modeling schemes. In this article, we extensively summarize a number of skin sensitization predictive models that can be used in the biopharmaceutics and cosmeceuticals industries as well as their future perspectives, and the underlined challenges are also discussed.

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“…59 More recently, the use of the Genomic Allergen Rapid Detection assay was proposed to determine the sensitizing potential of e-liquid ingredients. 60…”

Section: Challenges and Principles Of Evp Testingmentioning

confidence: 99%

State-of-the-art methods and devices for generation, exposure, and collection of aerosols from e-vapor products

Boué

Goedertier

Hoeng

et al. 2020

Toxicology Research and Application

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E-vapor products (EVP) have become popular alternatives for cigarette smokers who would otherwise continue to smoke. EVP research is challenging and complex, mostly because of the numerous and rapidly evolving technologies and designs as well as the multiplicity of e-liquid flavors and solvents available on the market. There is an urgent need to standardize all stages of EVP assessment, from the production of a reference product to e-vapor generation methods and from physicochemical characterization methods to nonclinical and clinical exposure studies. The objective of this review is to provide a detailed description of selected experimental setups and methods for EVP aerosol generation and collection and exposure systems for their in vitro and in vivo assessment. The focus is on the specificities of the product that constitute challenges and require development of ad hoc assessment frameworks, equipment, and methods. In so doing, this review aims to support further studies, objective evaluation, comparison, and verification of existing evidence, and, ultimately, formulation of standardized methods for testing EVPs.

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The use of Genomic Allergen Rapid Detection (GARD) assays to predict the respiratory and skin sensitising potential of e-liquids

Cited by 10 publications

References 41 publications

Application of a multi-layer systems toxicology framework for in vitro assessment of the biological effects of Classic Tobacco e-liquid and its corresponding aerosol using an e-cigarette device with MESH™ technology

Application of a multi-layer systems toxicology framework for in vitro assessment of the biological effects of Classic Tobacco e-liquid and its corresponding aerosol using an e-cigarette device with MESH™ technology

In silico Prediction of Skin Sensitization: Quo vadis?

State-of-the-art methods and devices for generation, exposure, and collection of aerosols from e-vapor products

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