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Advancing systemic toxicity risk assessment: Evaluation of a NAM-based toolbox approach

ABSTRACT: Advancing systemic toxicity risk assessment: Evaluation of a NAM-based toolbox approach

PROVIDER: PRJEB94531 | ENA |

REPOSITORIES: ENA

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Advancing systemic toxicity risk assessment: Evaluation of a NAM-based toolbox approach.

Project description:For many years, a method that allowed systemic toxicity safety assessments to be conducted without generating new animal test data, seemed out of reach. However, several different research groups and regulatory authorities are beginning to use a variety of in silico, in chemico, and in vitro techniques to inform safety decisions. To manage this transition to animal-free safety assessments responsibly, it is important to ensure that the level of protection offered by a safety assessment based on new approach methodologies (NAMs), is at least as high as that provided by a safety assessment based on traditional animal studies. To this end, we have developed an evaluation strategy to assess both the level of protection and the utility offered by a NAM-based systemic safety "toolbox." The toolbox comprises physiologically based kinetic models to predict internal exposures, and bioactivity NAMs designed to give broad coverage across many different toxicity modes of action. The output of the toolbox is the calculation of a bioactivity:exposure ratio (analogous to a margin of internal exposure), which can be used to inform decision-making. In this work, we have expanded upon an initial pilot study of 10 chemicals with an additional 38 chemicals and 70 consumer exposure scenarios. We found that, for the majority of these (>90%), the NAM-based workflow is protective of human health, enabling us to make animal-free safety decisions for systemic toxicity and preventing unnecessary animal use. We have also identified critical areas for improvement to further increase our confidence in the robustness of the approach.

| S-EPMC11879040 | biostudies-literature

An Advancement in Developmental and Reproductive Toxicity (DART) Risk Assessment: Evaluation of a Bioactivity and Exposure-Based NAM Toolbox

Project description:An Advancement in Developmental and Reproductive Toxicity (DART) Risk Assessment: Evaluation of a Bioactivity and Exposure-Based NAM Toolbox

| PRJEB94457 | ENA

Flavor Toolbox Assessment

Project description:The toxicity and potential associated molecular mechanism of a mixture of representative flavors, compared to a matrix containing propylene glicol (PG), vegetable glycerin (VG) and nicotine, were investigated with human bronchial epithelial cells using high-throughput screening and whole transcriptomics analysis.

2017-05-05 | E-MTAB-5317 | biostudies-arrayexpress

Advancing the genetic engineering toolbox by combining AsCas12a knock-in mice with ultra-compact screening

Project description:Advancing the genetic engineering toolbox by combining AsCas12a knock-in mice with ultra-compact screening

| PRJNA1206072 | ENA

Transcriptome profiling of human myogenic progenitors following treatment with nicotinamide (NAM) or pyridoxine (PN) or the combination (NAM/PN).

Project description:Working with primary human myogenic progenitors (hMPs), we developed a high-content screen to discover molecules that enhanced myogenic function and identified NAM and PN as modulators of myogenic proliferation and differentiation. We characterized genome-wide expression profiles of NAM-, PN-treated and NAM/PN-treated hMPs with the goal to uncover the mechanisms of action of NAM and PN and the potential additivity from the combination at the molecular level in hMPs.

2024-11-18 | GSE264285 | GEO

A rapid assessment model for liver toxicity of macrolides and an integrative evaluation for azithromycin impurities

Project description:we report an assessment of macrolides related liver toxicity by using ADMET prediction, molecular docking, structure-toxicity relationship and experimental verification via detecting the c-fos gene expression in liver cells.We employed the model to virtual screening of azithromycin impurities with high hepatotoxicity, and then experimental confirmed by liver toxicity in zebrafish, and c-fos gene expression.

2022-03-31 | GSE195903 | GEO

Effect of NAM on the TGFβ1-induced hESC-derived corneal endothelial progenitor cells

Project description:To further explore the effect of NAM on the TGFβ1-induced hESC-derived corneal endothelial progenitor cells, we have employed whole RNA microarray expression profiling as a discovery platform to identify genes and mechanism of NAM on the EnMT and senescence. hESC-derived endothelial progenotors were culured under 30ng/ml TGFβ1 with or without 50 mM NAM. The cultures were incubated for 72 hours at 37 ºC in a humidified incubator with 5% CO2.

2022-01-05 | GSE183786 | GEO

CGH: NAM parent lines vs. Wm82-ISU-01

Project description:Soybean nested association mapping (NAM) parent lines were compared by CGH to catalog structurally variant (e.g. deletion and duplication) regions among these genotypes. The CGH comparisons reveal reveal putative deletions and duplications among the 41 lines.

2014-03-30 | GSE56351 | GEO

A toolbox for epitope-tagging and genome-wide location analysis in Candida albicans

Project description:Background : Candida albicans is a diploid pathogenic fungus not yet amenable to routine genetic investigations. Understanding aspects of the regulation of its biological functions and the assembly of its protein complexes would lead to further insight into the biology of this common disease-causing microbial agent. Results: We have developed a toolbox allowing in vivo protein tagging by PCR-mediated homologous recombination with TAP, HA and MYC tags. The transformation cassettes were designed to accommodate a common set of integration primers. The tagged proteins can be used to perform tandem affinity purification (TAP) or chromatin immunoprecipitation coupled with microarray analysis (ChIP-CHIP). Tandem affinity purification of C. albicans Nop1 revealed the high conservation of the small processome composition in yeasts. Data obtained with in vivo TAP-tagged Tbf1, Cbf1 and Mcm1 recapitulates previously published genome-wide location profiling by ChIP-CHIP. We also designed a new reporter system for in vivo analysis of transcriptional activity of gene loci in C. albicans. Conclusion: This toolbox provides a basic setup to perform purification of protein complexes and increase the number of annotated transcriptional regulators and genetic circuits in C. albicans. Two independent biological replicates of ChIP-CHIP of Mcm1-TAP in yeast and hyphal states. ChIP-CHIP of Cbf1-TAP and Tbf1-TAP.

2010-05-16 | E-GEOD-13427 | biostudies-arrayexpress

Transcriptome profiling of Gastrocnemius from mice following supplementation with the combination of nicotinamide and pyridoxine (NAM/PN)

Project description:Nicotinamide and pyridoxine have been identified in an in vitro screening as potent modulators of Muscel Stem cell activity. To test the in vivo efficacy (of NAM/PN) on muscle regneration, we used a mouse model of muscle injury and regeneration. Transcriptomic analyses on whole muscles harvested 5 days after muscle injury were performed to better understand the effect of NAM/PN.

2024-11-18 | GSE264284 | GEO

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