Skin Test Sensitivity Research Articles

Zahabba Patch: Innovation of Gingival Mucoadhesion Patch Combination of Ginger (Zingiber Officinale) and Black Cubit (Nigella Sativa) as Gingivitis Treatment

Background The prevalence of periodontal disease in Indonesia reaches 74.1%. Treatment of gingivitis by administering NSAIDs has a side effect of gastritis. Anti-inflammatory and analgesic derived from natural ingredients are known to cause minimal side effects on the patient's body. The active compounds gingerol in ginger (Zingiber officinale) and quercetin in black cumin (Nigella sativa) are known to function as good anti-inflammatory and analgesic agents. Objectives This study aims to analyze the effectiveness of gingerol in ginger extract and qurcetin in black cumin as an anti-inflammatory and analgesic packaged in a mucoadhesion patch as a treatment for gingivitis. Material and Methods Preparations of gingerol and quercetin were obtained by biocomputation using the PyRx program, the Pymol program, the RCSB PDB website, the Lipinski rule of five page, the PDBSum website, and also the pkCSM website. Physicochemical, pharmacokinetic, toxicity, and molecular docking tests were carried out to determine the biocompatibility of the active ingredients used. Results In the physicochemical tests, the compounds glycerol and quercetin can penetrate somatic cell membranes, have good solubility in water, can dissolve easily in the blood, are easily distributed in the body, and can maintain their position and bond strength with the target macro protein. The results of the AMES toxicity, Hepatotoxicity and skin sensitization tests showed negative values for both gingerol and quercetin. In the molecular docking test, the gingerol and quercetin compounds have a tendency to form bonds with COX-1 compared to arachidonic acid without having to increase the dose so that they become competitors to the native ligand. Conclusion The active compounds gingerol in ginger extract (Zingiber officinale) and quercetin in black cumin extract (Nigella sativa) contained in Zahabba patch are good anti-inflammatory and analgesic by inhibiting the synthesis of pro-inflammatory cytokines such as PGI2, PGE2, and TXA2 by being competitive inhibitor of the enzyme phospholipase A2 against membrane lipids and the enzyme cyclooxygenase-1 (COX-1) against arachidonic acid.

Comparison of Postoperative Outcomes in Two Lip-Splitting Approaches for Buccal Squamous Cell Carcinoma Ablation.

The choice of surgical access for resection and reconstruction of buccal squamous cell carcinoma (BSCC) with the lip-splitting incision is controversial. Thus, this study aimed to evaluate the clinical and functional outcomes of midline lip split with lazy-S incision (MLSI) against the lateral lip-splitting incision (LLSI). A retrospective review was conducted on 41 patients with primary BSCC who underwent resection and reconstruction using MLSI approach (n = 19) and LLSI approach (n = 22) between 2022 and 2024. Functional outcomes, including skin sensitivity testing, oral competency, lip movement, cold perception, and other relevant measures, were evaluated with appropriate scales. Functional satisfaction and Patient and Observer Scar Assessment Scale (POSAS) were analyzed. None of the patients in either group demonstrated differences in sensation to light touch from baseline at 6 months postoperatively. Patients with MLSI approach reported higher lip function satisfaction (p = 0.037), and no patients in either group reported drooling. Besides, groove formation was significantly more common in the LLSI compared to the MLSI groups (50% vs. 15.8%, respectively; p = 0.046). A statistically significant difference was also observed in the self-assessment of mouth-opening movement among MLSI patients (p = 0.041). No significant differences were found in the mean POSAS scores, except that irregularity and surface area parameters were better in the MLSI group. Objective sensation deficits are reversible and do not impact long-term daily activities. The MLSI approach provides better postoperative outcomes and low disfigurement perception.

A Novel Machine Learning Model and a Web Portal for Predicting the Human Skin Sensitization Effects of Chemical Agents.

Skin sensitization is a significant concern for chemical safety assessments. Traditional animal assays often fail to predict human responses accurately, and ethical constraints limit the collection of human data, necessitating a need for reliable in silico models of skin sensitization prediction. This study introduces HuSSPred, an in silico tool based on the Human Predictive Patch Test (HPPT). HuSSPred aims to enhance the reliability of predicting human skin sensitization effects for chemical agents to support their regulatory assessment. We have curated an extensive HPPT database and performed chemical space analysis and grouping. Binary and multiclass QSAR models were developed with Bayesian hyperparameter optimization. Model performance was evaluated via five-fold cross-validation. We performed model validation with reference data from the Defined Approaches for Skin Sensitization (DASS) app. HuSSPred models demonstrated strong predictive performance with CCR ranging from 55 to 88%, sensitivity between 48 and 89%, and specificity between 37 and 92%. The positive predictive value (PPV) ranged from 84 to 97%, versus negative predictive value (NPV) from 22 to 65%, and coverage was between 75 and 93%. Our models exhibited comparable or improved performance compared to existing tools, and the external validation showed the high accuracy and sensitivity of the developed models. HuSSPred provides a reliable, open-access, and ethical alternative to traditional testing for skin sensitization. Its high accuracy and reasonable coverage make it a valuable resource for regulatory assessments, aligning with the 3Rs principles. The publicly accessible HuSSPred web tool offers a user-friendly interface for predicting skin sensitization based on chemical structure.

Miliary TB in children and adolescents: a scoping review.

<sec><title>OBJECTIVE</title>To summarise the available literature regarding clinical presentation, immunological and microbiological diagnosis, treatment, and outcomes of miliary TB in children and adolescents.</sec><sec><title>METHODS</title>Four databases were searched from 1 January 1950 to 31 January 2023. "Miliary" and "disseminated" TB were the main search concepts.</sec><sec><title>FINDINGS</title>Of 257 studies, 1,883 patients with miliary TB were included. Bacille Calmette-Guérin (BCG) vaccination was confirmed in 223/549 (40.6%) children. Central nervous system (CNS) involvement was reported in 367/924 (39.7%) cases; many of them had no neurological symptoms despite also having abnormal brain imaging. Of 1,112 children with known outcomes, 341 (30.6%) died; mortality was higher in publications before 1995 (41.5%) and in children with CNS involvement (31.9%). TB microbiological confirmation (55.8%) and sensitivity of tuberculin skin test (46.9%) and QuantiFERON Gold (72.4%) were overall low.</sec><sec><title>CONCLUSIONS</title>Evidence is lacking to support best practices for paediatric miliary TB. Whether lumbar puncture (LP) and brain imaging should both be routinely done in miliary TB children, or a step-by-step approach based on initial LP findings, remains unclear. This study should inform policymakers and funding agencies about current significant gaps that need to be addressed by future high-quality studies.</sec>.

P02-10 Effects of storage of LabCyte EPI-MODEL24, the reconstructed human epidermis, on the in vitro skin sensitization test EpiSensA

P02-10 Effects of storage of LabCyte EPI-MODEL24, the reconstructed human epidermis, on the in vitro skin sensitization test EpiSensA

Comparing Skin and Serum Testing to Direct Challenge Outcomes in Children With β-Lactam Allergies

BackgroundThere is a scarcity of prospective studies investigating the relative roles of skin prick and intradermal testing, serum-specific Immunoglobulin E, and extended oral challenges in diagnosing children with reported beta-lactam allergies. ObjectiveTo determine the sensitivity and specificity of skin testing and serum-specific Immunoglobulin E in children with beta-lactam allergies, with immediate and non-immediate historic reactions. MethodsFour hundred children with parent-reported beta-lactam allergies were recruited into an open-label prospective study. Detailed allergy histories were collected. Those with medically observed and documented histories of anaphylaxis, requiring epinephrine, or SCARs were excluded. In total, 380 children underwent all testing modalities and a direct provocation test. Each child was followed up for a minimum of three years. ResultsTrue allergy in children was uncommon, 8·3% reacted to the direct provocation challenge or the 5-day extended oral provocation challenge. Children reporting cephalosporin allergy or a reaction within one year were more likely to react to direct provocation testing. The sensitivity, specificity, and positive predictive value of skin testing was 12·5%, 98·8% and 20·0% for direct challenge outcomes, 4·76%, 99·0% and 25·0% for extended challenge outcomes, and 6·9%, 99·0% and 40·0% for both challenges combined. Follow-up investigations revealed that 5·7% of children had a mild repeat reaction and 2·7% continued to avoid the culprit despite successful delabeling. The relabeling rate for children readmitted to hospital was 15% with the relabeing being unfounded. ConclusionGenuine beta-lactam allergies were rare, with over 90% of children effectively delabeled. Skin and serum-specific Immunoglobulin E testing did not aid the diagnosis of beta-lactam antibiotic allergy in children, regardless of medical history. Extended oral challenges proved valuable in confirming allergies and boosted parental confidence.

Formulation and Evaluation of Herbal Soap Containing Ocimum tenuiflorum (Tulsi) for Enhanced Skin Health

This study aimed to develop and evaluate a herbal soap formulation containing Ocimum tenuiflorum (Tulsi) and other natural ingredients to promote skin health. The soap was prepared using the double boiling method, incorporating Tulsi powder, turmeric, aloe vera gel, almond oil, rose water, and lavender essential oil into a glycerin soap base. The formulation process and ingredient selection were based on the therapeutic properties of each component, with a focus on antibacterial, anti-inflammatory, and moisturizing effects. The resulting soap was subjected to various evaluation parameters, including organoleptic properties, physical characteristics such as foam retention, foamability, and pH, as well as skin sensitivity and irritation tests. The herbal soap demonstrated favorable characteristics in terms of appearance, odor, and skin compatibility. Its natural composition offers potential advantages over conventional soaps, including the absence of harsh chemicals and the presence of active phytochemicals that may benefit skin health. This study contributes to the growing body of research on natural cosmetic formulations and highlights the potential of herbal ingredients in personal care products. Further research, including clinical trials, is recommended to fully elucidate the efficacy and long-term benefits of this herbal soap formulation for various skin types and conditions

Preparation of Anticancer Extract

In India, the hibiscus rosa-sinesis (HS) flower is well-known and is used to worship Lord Ganesha. China rose, or Hibiscus rosa sinensis, is a member of the Malvaceae family. In numerous tropical nations, this plant has a wide range of significant medical benefits for treating wounds, inflammation, fever and coughing, diabetes, infections caused by bacteria and fungi, hair loss, and gastric ulcers. According to phytochemical analysis, flavonoids, tannin, terpenoids, saponins, and alkaloids are the principal bioactive substances in charge of its therapeutic benefits. Various pharmacological properties, including anti-pyritic, analgesic, anti-inflammatory, anxiety study, and anti-depressant, were demonstrated by experiment from recent study. These reviews seek to provide information on the different pharmacological and pharmaceutical uses of Hibiscus rosa sinensis. The article discusses a few literary works that are based on the studies conducted on Hibiscus rosa sinensis. Background: Infectious diseases are the most common causes of morbidity and mortality in developing countries.Wound and wound infections are also major health problem. Nowadays, medicinal plants play a major role intreatment of infectious diseases and wound healing and they are easily available and more affordable as comparedto synthetic compounds. The aim of this study is therefore, to investigate the antibacterial and wound healingactivities of 80% methanol extract of Hibiscus micranthus leaves using disc diffusion methods and rat excisionmodel respectively.Methods: In vitro antibacterial screening was carried out against S. aureus, S.pneumoniae, S. pyogenes, E. coli, P.aeruginosa, K. pneumoniae and P. mirabilis bacterial strains using disc-well diffusion assay. Would healing activity wasdone in rats divided into four groups each consisting of six animals. Group I was served as a negative control(ointment base), Group II served as a positive control Nitrofurazone (NFZ 0.2% ointment), Groups III and IV wastreated 5 and 10% extracts respectively. The acute oral toxicity test and skin sensitivity test were also performed before conducting the actual study. The extract was analyzed for secondary meta using.

Mixed methods study on latent tuberculosis among agate stone workers and advocacy for testing silica dust exposed individuals in India

The 2021 tuberculosis (TB) preventive treatment guidelines in India included silicosis as a screening group, yet latent TB infection (LTBI) testing for silica-dust-exposed individuals is underemphasized. Focusing on an estimated 52 million silica-dust-exposed workers, particularly agate-stone workers in Khambhat, Gujarat, our study aims to estimate LTBI prevalence, identify predictors, and gather insights from TB and silicosis experts. Employing a sequential explanatory mixed-methods approach, a cross-sectional study involved 463 agate-stone workers aged ≥ 20 years in Khambhat, using IGRA kits for LTBI testing. In-depth interviews with experts complemented quantitative findings. Among agate-stone workers, 58% tested positive for LTBI, with predictors including longer exposure, type of work, and BCG vaccination. Our findings reveal a nearly double burden of LTBI compared to the general population, particularly in occupations with higher silica dust exposure. Experts advocate for including silica-dust-exposed individuals in high-risk groups for LTBI testing, exploring cost-effective alternatives like improved skin sensitivity tests, and shorter TB preventive treatment regimens to enhance compliance. Future research should explore upfront TB preventive treatment for silica-dust-exposed individuals with high LTBI prevalence and optimal exposure duration. This study underscores the urgent need for policy changes and innovative approaches to TB prevention among silica-dust-exposed populations, impacting global occupational health strategies.

Next-generation skin cancer treatment: A quality by design perspective on artificial neural network-optimized cationic ethosomes with bleomycin sulphate

Skin cancer, exacerbated by environmental factors like ozone layer depletion, poses a global health concern. Topical administration of chemotherapy, a promising approach, minimizes systemic toxicity. Bleomycin Sulphate (BLM), effective intravenously, faces challenges due to limited skin penetration. Cationic ethosomes, known for superior skin penetration, address this by enhancing electrostatic interactions with cancer cells. This ensures localized drug delivery, preventing systemic circulation. Employing thin film hydration, we prepared cationic ethosomes with BLM, optimizing through Artificial Neural Network (ANN) and Response Surface Methodology (RSM). Characterization included entrapment efficiency, vesicle size, morphology, and zeta potential. In-vitro drug release and various kinetic models were analyzed. Ex-vivo evaluations, like dermatokinetic studies and fluorescence microscopy, and in-vivo skin sensitivity testing were conducted. Results showed the optimized formulation with 27.1 % entrapment efficiency, 144.3 nm vesicle size, smooth surface morphology, and positive zeta potential. Ex-vivo assessments indicated favorable skin retention and in-vivo tests suggested suitability for topical administration, highlighting its potential in skin cancer treatment. This research offers a promising strategy for localized and effective skin cancer therapy, addressing challenges associated with systemic toxicity and limited drug penetration.

Biosafety and chemical solubility studies of multiscale crystal-reinforced lithium disilicate glass-ceramics.

Lithium disilicate (Li2 Si2 O5 ) glass-ceramics are currently a more widely used all-ceramic restorative material due to their good mechanical properties and excellent aesthetic properties. However, they have a series of problems such as high brittleness and low fracture toughness, which has become the main bottleneck restricting its development. Therefore, in order to compensate for these shortcomings, we propose to prepare a reinforced glass-ceramics with better mechanical properties and to test the biosafety and chemical solubility of the material. Li2 Si2 O5 whiskers were synthesized by a one-step hydrothermal method, and multi-scale crystal-enhanced Li2 Si2 O5 glass-ceramics were prepared by reaction sintering. The biosafety of multi-scale crystal-reinforced Li2 Si2 O5 glass-ceramics was investigated by in vitro cytotoxicity test, rabbit pyrogen test, mice bone marrow micronucleus test, skin sensitization test, sub-chronic systemic toxicity test, and chronic systemic toxicity test. Additionally, the chemical solubility of multi-scale crystal-reinforced Li2 Si2 O5 glass-ceramics was investigated. The test results showed that the material was non-cytotoxic, non-thermogenic, non-mutagenic, non-sensitizing, and non-systemic. The chemical solubility, determined to be 377 ± 245 μg/cm2 , complied with the ISO 6872 standard for the maximum solubility of ceramic materials. Multi-scale crystal-reinforced Li2 Si2 O5 glass-ceramics' biosafety and chemical solubility met current normative criteria, and they can move on to mechanical property measurements (such as flexural strength test, fatigue life test, friction and wear property study, etc.) and bonding property optimization, which shows promise for future clinical applications.

Use of in vitro methods combined with in silico analysis to identify potential skin sensitizers in the Tox21 10K compound library.

Introduction: Skin sensitization, which leads to allergic contact dermatitis, is a key toxicological endpoint with high occupational and consumer prevalence. This study optimized several in vitro assays listed in OECD skin sensitization test guidelines for use on a quantitative high-throughput screening (qHTS) platform and performed in silico model predictions to assess the skin sensitization potential of prioritized compounds from the Tox21 10K compound library. Methods: First, we screened the entire Tox21 10K compound library using a qHTS KeratinoSensTM (KS) assay and built a quantitative structure-activity relationship (QSAR) model based on the KS results. From the qHTS KS screening results, we prioritized 288 compounds to cover a wide range of structural chemotypes and tested them in the solid phase extraction-tandem mass spectrometry (SPE-MS/MS) direct peptide reactivity assay (DPRA), IL-8 homogeneous time-resolved fluorescence (HTRF) assay, CD86 and CD54 surface expression in THP1 cells, and predicted in silico sensitization potential using the OECD QSAR Toolbox (v4.5). Results: Interpreting tiered qHTS datasets using a defined approach showed the effectiveness and efficiency of in vitro methods. We selected structural chemotypes to present this diverse chemical collection and to explore previously unidentified structural contributions to sensitization potential. Discussion: Here, we provide a skin sensitization dataset of unprecedented size, along with associated tools, and analysis designed to support chemical assessments.

Selective ILM Staining and Safety of Two Vital Dyes During a Human-Like Pars Plana Vitrectomy Ex Vivo in Porcine Eyes

Purpose An ideal dye for intraocular use should effectively stain the target tissue while being easy to apply and remove. Additionally, it should not have any adverse effects resulting from prolonged contact with the retinal tissue. Recently, concerns have been raised about the safety of some vital dyes during surgical procedures as they may cross the internal limiting membrane and deposit on the retina. In this study, we aimed to investigate whether commercially available vital dyes, VIEW-ILM® and TWIN® (AL.CHI.MI.A. S.r.l., Ponte San Nicolò, Padova, Italy), have the potential to cross the internal limiting membrane during vitreoretinal surgery and deposit on the retina. Furthermore, we evaluated their safety in vitro and in vivo. Methods A human-like pars plana vitrectomy was performed on porcine eyes ex vivo, with VIEW-ILM® or TWIN® used to stain the internal limiting membrane either with or without subsequent internal limiting membrane peeling. The two dyes were then extracted from retinal punches with or without internal limiting membrane, and quantified using high performance liquid chromatography. Safety was evaluated through in vitro cytotoxicity tests and in vivo skin sensitization and irritation tests according to ISO standards. Results High performance liquid chromatography analyses demonstrated that VIEW-ILM® and TWIN® effectively stained the internal limiting membrane without crossing the membrane. No residual dyes were found in the retinal layers after internal limiting membrane removal. Furthermore, both in vitro and in vivo safety tests confirmed the absence of cytotoxicity, skin sensitization, and irritation. Conclusion The results of this study support the safety and efficacy of VIEW-ILM® and TWIN® for internal limiting membrane staining. The experimental protocol described in this study could be utilized to gain a comprehensive understanding of the characteristics of vital dyes.

Proof of concept testing of a positive reference material for in vivo and in vitro sensitization testing of medical devices.

In vivo skin sensitization tests are required to evaluate the biological safety of medical devices in contact with living organisms to provide safe medical care to patients. Negative and positive reference materials have been developed for biological tests of cytotoxicity, implantation, hemolysis, and in vitro skin irritation. However, skin sensitization tests are lacking. In this study, polyurethane sheets containing 1 wt/wt % 2,4-dinitrochlorobenzene (DNCB-PU) were developed and evaluated as a positive reference material for skin sensitization tests. DNCB-PU sheet extracts prepared with sesame oil elicited positive sensitization responses for in vivo sensitization potential in the guinea pig maximization test and the local lymph node assay. Furthermore, DNCB-PU sheet extracts prepared with water and acetonitrile, 10% fetal bovine serum-containing medium, or sesame oil elicited positive sensitization responses as alternatives to animal testing based on the amino acid derivative reactivity assay, human cell line activation test, and epidermal sensitization assay, respectively. These data suggest that the DNCB-PU sheet is an effective extractable positive reference material for in vivo and in vitro skin sensitization testing in medical devices. The formulation of this reference material will lead to the development of safer medical devices that contribute to patient safety.

The sensitivity of food allergy skin testing soon after food-induced anaphylaxis

The sensitivity of food allergy skin testing soon after food-induced anaphylaxis

In Vitro and In Vivo Methods for Analysis of Nanoparticles' Potential toInduce Delayed-Type Hypersensitivity Reactions.

Delayed-type hypersensitivity (DTH) reactions are among the common reasons for drug withdrawal from clinical use during the post-marketing stage. Several in vivo methods have been developed to test DTH responses in animal models. They include the local lymph node assay (LLNA) and local lymph node proliferation assay (LLNP). While LLNA is instrumental in testing topically administered formulations (e.g., creams), the LLNP was proven to be predictive of drug-mediated DTH in response to small molecule pharmaceuticals. Global efforts in reducing the use of research animals lead to the development of in vitro models to predict test-materials' mediated DTH. Two such models include theanalysis of surface marker expression in human cell lines THP-1 and U-937. These tests are known as the human cell line activation test (hCLAT) and myeloid U937 skin sensitization test (MUSST or U-SENS), respectively. Here we describe experimental procedures for all these methods, discuss their in vitro-in vivo correlation, and suggest a strategy for applying these tests to analyze engineered nanomaterials and nanotechnology-formulated drug products.

Sveobuhvatan pregled testa direktne reaktivnosti peptida u ispitivanju preosetljivosti kože - primenjivost, ograničenja i razmatranja

Skin sensitization is a crucial endpoint in the safety assessment of chemicals, with the Direct Peptide Reactivity Assay (DPRA) emerging as a valuable in chemico method for evaluating a substance's sensitization potential. This review delves into the principles, applicability, and limitations of the DPRA within the context of the Adverse Outcome Pathway (AOP) framework for skin sensitization. We examine the DPRA'srole in addressing the molecular initiating event of skin sensitization, its integration into Integrated Approaches to Testing and Assessment (IATA), and its performance in predicting sensitizers. The review also highlights the challenges in testing certain categories of chemicals and the importance of considering the DPRA's results alongside other complementary methods. By providing a comprehensive overview of the DPRA, this review aims to inform researchers, regulators, and clinicians about its utility and limitations in the context of skin sensitization testing.

Development of machine learning models for the prediction of the skin sensitization potential of cosmetic compounds.

To enhance the accuracy of allergen detection in cosmetic compounds, we developed a co-culture system that combines HaCaT keratinocytes (transfected with a luciferase plasmid driven by the AKR1C2 promoter) and THP-1 cells for machine learning applications. Following chemical exposure, cell cytotoxicity was assessed using CCK-8 to determine appropriate stimulation concentrations. RNA-Seq was subsequently employed to analyze THP-1 cells, followed by differential expression gene (DEG) analysis and weighted gene co-expression net-work analysis (WGCNA). Using two data preprocessing methods and three feature extraction techniques, we constructed and validated models with eight machine learning algorithms. Our results demonstrated the effectiveness of this integrated approach. The best performing models were random forest (RF) and voom-based diagonal quadratic discriminant analysis (voomDQDA), both achieving 100% accuracy. Support vector machine (SVM) and voom based nearest shrunken centroids (voomNSC) showed excellent performance with 96.7% test accuracy, followed by voom-based diagonal linear discriminant analysis (voomDLDA) at 95.2%. Nearest shrunken centroids (NSC), Poisson linear discriminant analysis (PLDA) and negative binomial linear discriminant analysis (NBLDA) achieved 90.5% and 90.2% accuracy, respectively. K-nearest neighbors (KNN) showed the lowest accuracy at 85.7%. This study highlights the potential of integrating co-culture systems, RNA-Seq, and machine learning to develop more accurate and comprehensive in vitro methods for skin sensitization testing. Our findings contribute to the advancement of cosmetic safety assessments, potentially reducing the reliance on animal testing.

Safety tests and clinical research on buccal and nasal microneedle swabs for genomic analysis.

Conventional swabs have been used as a non-invasive method to obtain samples for DNA analysis from the buccal and the nasal mucosa. However, swabs may not always collect pure enough genetic material. In this study, buccal and nasal microneedle swab is developed to improve the accuracy and reliability of genomic analysis. A cytotoxicity test, a skin sensitivity test, and a skin irritation test are conducted with microneedle swabs. Polymer microneedle swabs meet the safety requirements for clinical research and commercial use. When buccal and nasal microneedle swabs are used, the amount of genetic material obtained is greater than that from commercially available swabs, and DNA purity is also high. The comparatively short microneedle swab (250μm long) cause almost no pain to all 25 participants. All participants also report that the microneedle swabs are very easy to use. When genotypes are compared at five SNP loci from blood of a participant and from that person's buccal or nasal microneedle swab, the buccal and nasal microneedle swabs show 100% concordance for all five SNP genotypes. Microneedle swabs can be effectively used for genomic analysis and prevention through genomic analysis, so the utilization of microneedle swabs is expected to be high.

Reconstructed human epidermis-based testing strategy of skin sensitization potential and potency classification using epidermal sensitization assay and in silico data.

The hazards and potency of skin sensitizers are traditionally determined using animal tests such as the local lymph node assay (LLNA); however, significant progress has been made in the development of non-animal test methods addressing the first three mechanistic key events of adverse outcome pathway in skin sensitization. We developed the epidermal sensitization assay (EpiSensA), which is a reconstructed human epidermis-based assay, by measuring four genes related to critical keratinocyte responses during skin sensitization. Four in vitro skin sensitization test methods (EpiSensA, direct peptide reactivity assay [DPRA], KeratinoSens™, and human cell line activation test [h-CLAT]) were systematically evaluated using 136 chemicals including lipophilic chemicals and pre/pro-haptens, which may be related to assay-specific limitations. The constructed database included existing and newly generated data. The EpiSensA showed a broader applicability domain and predicted the hazards with 82.4% and 78.8% accuracy than LLNA and human data. The EpiSensA could detect 76 out of 88 sensitizers at lower concentrations than the LLNA, indicating that the EpiSensA has higher sensitivity for the detection of minor sensitizing constituents. These results confirmed the potential use of the EpiSensA in evaluating a mixture of unknown compositions that can be evaluated by animal tests. To combine different information sources, the reconstructed human epidermis-based testing strategy (RTS) was developed based on weighted multiple information from the EpiSensA and TImes MEtabolism Simulator platform for predicting Skin Sensitization (TIMES-SS; RTSv1) or Organization for Economic Cooperation and Development (OECD) QSAR Toolbox automated workflow (RTSv2). The predictivities of the hazards and Globally Harmonized System (GHS) subcategories were equal to or better than the defined approaches (2 out of 3, integrated testing strategy [ITS]v1, and ITSv2) adopted as OECD Guideline 497.