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Book ; Online ; E-Book: Toxicogenomics in predictive carcinogenicity

Waters, Michael D. / Thomas, Russell S.

(Issues in toxicology ; 28)

2016

Author's details	edited by Michael D. Waters (Michael Waters Consulting, Hillborough, NC, USA), Russell S. Thomas (US Environmental Protection Agency, Research Triangle Park, NC, USA)
Series title	Issues in toxicology ; 28
Collection
Language	English
Size	1 Online-Ressource (ix, 503 pages)
Publisher	Royal Society of Chemistry
Publishing place	Cambridge
Publishing country	Great Britain
Document type	Book ; Online ; E-Book
Remark	Zugriff für angemeldete ZB MED-Nutzerinnen und -Nutzer
HBZ-ID	HT019067247
ISBN	978-1-78262-405-9 ; 1-78262-405-8
Database	ZB MED Catalogue: Medicine, Health, Nutrition, Environment, Agriculture

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Article ; Online: Adverse effects in traditional and alternative toxicity tests.

Browne, Patience / Paul Friedman, Katie / Boekelheide, Kim / Thomas, Russell S

Regulatory toxicology and pharmacology : RTP

2024 Volume 148, Page(s) 105579

Abstract: Chemical safety assessment begins with defining the lowest level of chemical that alters one or more measured endpoints. This critical effect level, along with factors to account for uncertainty, is used to derive limits for human exposure. In the ... ...

Abstract	Chemical safety assessment begins with defining the lowest level of chemical that alters one or more measured endpoints. This critical effect level, along with factors to account for uncertainty, is used to derive limits for human exposure. In the absence of data regarding the specific mechanisms or biological pathways affected, non-specific endpoints such as body weight and non-target organ weight changes are used to set critical effect levels. Specific apical endpoints such as impaired reproductive function or altered neurodevelopment have also been used to set chemical safety limits; however, in test guidelines designed for specific apical effect(s), concurrently measured non-specific endpoints may be equally or more sensitive than specific endpoints. This means that rather than predicting a specific toxicological response, animal data are often used to develop protective critical effect levels, without assuming the same change would be observed in humans. This manuscript is intended to encourage a rethinking of how adverse chemical effects are interpreted: non-specific endpoints from in vivo toxicological studies data are often used to derive points of departure for use with safety assessment factors to create recommended exposure levels that are broadly protective but not necessarily target-specific.
MeSH term(s)	Animals ; Humans ; Toxicity Tests ; Risk Assessment
Language	English
Publishing date	2024-02-01
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	604672-1
ISSN	1096-0295 ; 0273-2300
ISSN (online)	1096-0295
ISSN	0273-2300
DOI	10.1016/j.yrtph.2024.105579
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Article ; Online: Technical evaluation and standardization of the human thyroid microtissue assay.

Foley, Briana / Hopperstad, Kristen / Gamble, John / Lynn, Scott G / Thomas, Russell S / Deisenroth, Chad

Toxicological sciences : an official journal of the Society of Toxicology

2024 Volume 199, Issue 1, Page(s) 89–107

Abstract: The success and sustainability of U.S. EPA efforts to reduce, refine, and replace in vivo animal testing depends on the ability to translate toxicokinetic and toxicodynamic data from in vitro and in silico new approach methods (NAMs) to human-relevant ... ...

Abstract	The success and sustainability of U.S. EPA efforts to reduce, refine, and replace in vivo animal testing depends on the ability to translate toxicokinetic and toxicodynamic data from in vitro and in silico new approach methods (NAMs) to human-relevant exposures and health outcomes. Organotypic culture models employing primary human cells enable consideration of human health effects and inter-individual variability but present significant challenges for test method standardization, transferability, and validation. Increasing confidence in the information provided by these in vitro NAMs requires setting appropriate performance standards and benchmarks, defined by the context of use, to consider human biology and mechanistic relevance without animal data. The human thyroid microtissue (hTMT) assay utilizes primary human thyrocytes to reproduce structural and functional features of the thyroid gland that enable testing for potential thyroid-disrupting chemicals. As a variable-donor assay platform, conventional principles for assay performance standardization need to be balanced with the ability to predict a range of human responses. The objectives of this study were to (1) define the technical parameters for optimal donor procurement, primary thyrocyte qualification, and performance in the hTMT assay, and (2) set benchmark ranges for reference chemical responses. Thyrocytes derived from a cohort of 32 demographically diverse euthyroid donors were characterized across a battery of endpoints to evaluate morphological and functional variability. Reference chemical responses were profiled to evaluate the range and chemical-specific variability of donor-dependent effects within the cohort. The data-informed minimum acceptance criteria for donor qualification and set benchmark parameters for method transfer proficiency testing and validation of assay performance.
MeSH term(s)	Humans ; Thyroid Gland/drug effects ; Female ; Male ; Adult ; Middle Aged ; Thyroid Epithelial Cells/drug effects ; Thyroid Epithelial Cells/metabolism ; Cells, Cultured ; Endocrine Disruptors/toxicity ; Young Adult ; Biological Assay/standards ; Biological Assay/methods ; Reproducibility of Results ; Animal Testing Alternatives/standards ; Aged ; Benchmarking
Chemical Substances	Endocrine Disruptors
Language	English
Publishing date	2024-02-01
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	1420885-4
ISSN	1096-0929 ; 1096-6080
ISSN (online)	1096-0929
ISSN	1096-6080
DOI	10.1093/toxsci/kfae014
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Article ; Online: Assessing Safety Without Animal Testing: The Road Ahead.

Daston, George P / Mahony, Catherine / Thomas, Russell S / Vinken, Mathieu

Toxicological sciences : an official journal of the Society of Toxicology

2022 Volume 187, Issue 2, Page(s) 214–218

MeSH term(s)	Animal Testing Alternatives ; Animals
Language	English
Publishing date	2022-05-04
Publishing country	United States
Document type	Journal Article
ZDB-ID	1420885-4
ISSN	1096-0929 ; 1096-6080
ISSN (online)	1096-0929
ISSN	1096-6080
DOI	10.1093/toxsci/kfac039
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Article: Towards reproducible structure-based chemical categories for PFAS to inform and evaluate toxicity and toxicokinetic testing.

Patlewicz, Grace / Richard, Ann M / Williams, Antony J / Judson, Richard S / Thomas, Russell S

Computational toxicology (Amsterdam, Netherlands)

2023 Volume 24

Abstract: Per- and Polyfluoroalkyl substances (PFAS) are a class of synthetic chemicals that are in widespread use and present concerns for persistence, bioaccumulation and toxicity. Whilst a handful of PFAS have been characterised for their hazard profiles, the ... ...

Abstract	Per- and Polyfluoroalkyl substances (PFAS) are a class of synthetic chemicals that are in widespread use and present concerns for persistence, bioaccumulation and toxicity. Whilst a handful of PFAS have been characterised for their hazard profiles, the vast majority of PFAS have not been studied. The US Environmental Protection Agency (EPA) undertook a research project to screen ~150 PFAS through an array of different
Language	English
Publishing date	2023-03-10
Publishing country	Netherlands
Document type	Journal Article
ISSN	2468-1113
ISSN	2468-1113
DOI	10.1016/j.comtox.2022.100250
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Article ; Online: Evaluation of a high-throughput H295R homogenous time resolved fluorescence assay for androgen and estrogen steroidogenesis screening.

Garnovskaya, Maria / Feshuk, Madison / Stewart, Wendy / Friedman, Katie Paul / Thomas, Russell S / Deisenroth, Chad

Toxicology in vitro : an international journal published in association with BIBRA

2023 Volume 92, Page(s) 105659

Abstract: The H295R test guideline assay evaluates the effect of test substances on synthesis of 17β-estradiol (E2) and testosterone (T). The objective of this study was to leverage commercial immunoassay technology to develop a more efficient H295R assay to ... ...

Abstract	The H295R test guideline assay evaluates the effect of test substances on synthesis of 17β-estradiol (E2) and testosterone (T). The objective of this study was to leverage commercial immunoassay technology to develop a more efficient H295R assay to measure E2 and T levels in 384-well format. The resulting Homogenous Time Resolved Fluorescence assay platform (H295R-HTRF) was evaluated against a training set of 36 chemicals derived from the OECD inter-laboratory validation study, EPA guideline 890.1200 aromatase assay, and azole fungicides active in the HT-H295R assay. Quality control performance criteria were met for all conditions except E2 synthesis inhibition where low basal hormone synthesis was observed. Five proficiency chemicals were active for both the E2 and T endpoints, consistent with guideline classifications. Of the nine OECD core reference chemicals, 9/9 were concordant with outcomes for E2 and 7/9 for T. Likewise, 9/13 and 11/13 OECD supplemental chemicals were concordant with anticipated effects for E2 and T, respectively. Of the 10 azole fungicides screened, 7/10 for E2 and 8/10 for T exhibited concordant outcomes for inhibition. Generally, all active chemicals in the training set demonstrated equivalent or greater potency in the H295R-HTRF assay, supporting the sensitivity of the platform. The adaptation of HTRF technology to the H295R model provides an efficient way to evaluate E2 and T modulators in accordance with guideline specifications.
MeSH term(s)	Androgens ; Fungicides, Industrial ; Cell Line, Tumor ; Endocrine Disruptors ; Estrogens ; Estradiol ; Testosterone ; Azoles/pharmacology
Chemical Substances	Androgens ; Fungicides, Industrial ; Endocrine Disruptors ; Estrogens ; Estradiol (4TI98Z838E) ; Testosterone (3XMK78S47O) ; Azoles
Language	English
Publishing date	2023-08-07
Publishing country	England
Document type	Journal Article
ZDB-ID	639064-x
ISSN	1879-3177 ; 0887-2333
ISSN (online)	1879-3177
ISSN	0887-2333
DOI	10.1016/j.tiv.2023.105659
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Article ; Online: Dermal absorption of high molecular weight parent and alkylated polycyclic aromatic hydrocarbons from manufactured gas plant soils using in vitro assessment.

Williams-Clayson, Alison M / Vane, Christopher H / Jones, Matthew D / Thomas, Russell / Taylor, Christopher / Beriro, Darren J

Journal of hazardous materials

2024 Volume 469, Page(s) 133858

Abstract: An enhanced in vitro human dermal bioavailability method was developed to measure the release of twenty parent and seven alkylated high molecular weight (HMW) polycyclic aromatic hydrocarbons (PAHs) from contaminated soils collected from five former ... ...

Abstract	An enhanced in vitro human dermal bioavailability method was developed to measure the release of twenty parent and seven alkylated high molecular weight (HMW) polycyclic aromatic hydrocarbons (PAHs) from contaminated soils collected from five former manufactured Gas Plants (MGP) in England. GC-MS/MS was used to quantify HMW PAHs in soil, Strat-M artificial membrane representing skin, and synthetic receptor solution (RS) representing systemic circulation at 1-h, 10-h, and 24-h timesteps. Fluoranthene and pyrene exhibited the highest fluxes from soils to membrane (ranging from 9.5 - 281 ng/cm
MeSH term(s)	Humans ; Polycyclic Aromatic Hydrocarbons/analysis ; Soil ; Tandem Mass Spectrometry ; Molecular Weight ; Soil Pollutants/analysis ; Pyrenes ; Environmental Monitoring/methods ; Fluorenes
Chemical Substances	Polycyclic Aromatic Hydrocarbons ; fluoranthene (360UOL779Z) ; Soil ; Soil Pollutants ; pyrene (9E0T7WFW93) ; Pyrenes ; Fluorenes
Language	English
Publishing date	2024-02-22
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	1491302-1
ISSN	1873-3336 ; 0304-3894
ISSN (online)	1873-3336
ISSN	0304-3894
DOI	10.1016/j.jhazmat.2024.133858
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Article ; Online: Does diffusion of horse-related military technologies explain spatiotemporal patterns of social complexity 1500 BCE-AD 1500?

Thomas, Russell C

Proceedings of the National Academy of Sciences of the United States of America

2014 Volume 111, Issue 4, Page(s) E414

MeSH term(s)	Cultural Evolution ; Humans ; Models, Theoretical ; Population Dynamics ; Social Change
Language	English
Publishing date	2014-01-17
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	209104-5
ISSN	1091-6490 ; 0027-8424
ISSN (online)	1091-6490
ISSN	0027-8424
DOI	10.1073/pnas.1322270111
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Article ; Online: Estimating Hepatotoxic Doses Using High-Content Imaging in Primary Hepatocytes.

Shah, Imran / Antonijevic, Todor / Chambers, Bryant / Harrill, Joshua / Thomas, Russell

Toxicological sciences : an official journal of the Society of Toxicology

2021 Volume 183, Issue 2, Page(s) 285–301

Abstract: Using in vitro data to estimate point of departure (POD) values is an essential component of new approach methodologies (NAMs)-based chemical risk assessments. In this case study, we evaluated a NAM for hepatotoxicity based on rat primary hepatocytes, ... ...

Abstract	Using in vitro data to estimate point of departure (POD) values is an essential component of new approach methodologies (NAMs)-based chemical risk assessments. In this case study, we evaluated a NAM for hepatotoxicity based on rat primary hepatocytes, high-content imaging (HCI), and toxicokinetic modeling. First, we treated rat primary hepatocytes with 10 concentrations (0.2-100 µM) of 51 chemicals that produced hepatotoxicity in repeat-dose subchronic and chronic exposures. Second, we used HCI to measure endoplasmic reticulum stress, mitochondrial function, lysosomal mass, steatosis, apoptosis, DNA texture, nuclear size, and cell number at 24, 48, and 72 h and calculated concentrations at 50% maximal activity (AC50). Third, we estimated administered equivalent doses (AEDs) from AC50 values using toxicokinetic modeling. AEDs using physiologically based toxicokinetic models were 4.1-fold (SD 6.3) and 8.1-fold (SD 15.5) lower than subchronic and chronic lowest observed adverse effect levels (LOAELs), respectively. In contrast, AEDs from ToxCast and Tox21 assays were 89.8-fold (SD 149.5) and 168-fold (SD 323.7) lower than subchronic and chronic LOAELs. Individual HCI endpoints also estimated AEDs for specific hepatic lesions that were lower than in vivo PODs. Lastly, AEDs were similar for different in vitro exposure durations, but steady-state toxicokinetic models produced 7.6-fold lower estimates than dynamic physiologically based ones. Our findings suggest that NAMs from diverse cell types provide conservative estimates of PODs. In contrast, NAMs based on the same species and cell type as the adverse outcome may produce estimates closer to the traditional in vivo PODs.
MeSH term(s)	Animals ; Biological Assay ; Drug-Related Side Effects and Adverse Reactions ; Hepatocytes/drug effects ; Rats ; Risk Assessment
Language	English
Publishing date	2021-07-20
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	1420885-4
ISSN	1096-0929 ; 1096-6080
ISSN (online)	1096-0929
ISSN	1096-6080
DOI	10.1093/toxsci/kfab091
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Article ; Online: Chemical Screening in an Estrogen Receptor Transactivation Assay With Metabolic Competence.

Hopperstad, Kristen / DeGroot, Danica E / Zurlinden, Todd / Brinkman, Cassandra / Thomas, Russell S / Deisenroth, Chad

Toxicological sciences : an official journal of the Society of Toxicology

2022 Volume 187, Issue 1, Page(s) 112–126

Abstract: The U.S. EPA continues to utilize high-throughput screening data to evaluate potential biological effects of endocrine active substances without the use of animal testing. Determining the scope and need for in vitro metabolism in high-throughput assays ... ...

Abstract	The U.S. EPA continues to utilize high-throughput screening data to evaluate potential biological effects of endocrine active substances without the use of animal testing. Determining the scope and need for in vitro metabolism in high-throughput assays requires the generation of larger data sets that assess the impact of xenobiotic transformations on toxicity-related endpoints. The objective of the current study was to screen a set of 768 ToxCast chemicals in the VM7Luc estrogen receptor transactivation assay (ERTA) using the Alginate Immobilization of Metabolic Enzymes hepatic metabolism method. Chemicals were screened with or without metabolism to identify estrogenic effects and metabolism-dependent changes in bioactivity. Based on estrogenic hit calls, 85 chemicals were active in both assay modes, 16 chemicals were only active without metabolism, and 27 chemicals were only active with metabolism. Using a novel metabolism curve shift method that evaluates the shift in concentration-response curves, 29 of these estrogenic chemicals were identified as bioactivated and 59 were bioinactivated. Human biotransformation routes and associated metabolites were predicted in silico across the chemicals to mechanistically characterize possible transformation-related ERTA effects. Overall, the study profiled novel chemicals associated with metabolism-dependent changes in ERTA bioactivity, and suggested routes of biotransformation and putative metabolites responsible for the observed estrogenic effects. The data demonstrate a range of metabolism-dependent effects across a diverse chemical library and highlight the need to evaluate the role of intrinsic xenobiotic metabolism for endocrine and other toxicity-related health effects.
MeSH term(s)	Animals ; Endocrine Disruptors/toxicity ; Estrogens/toxicity ; Estrone ; Receptors, Estrogen/genetics ; Receptors, Estrogen/metabolism ; Transcriptional Activation ; Xenobiotics/toxicity
Chemical Substances	Endocrine Disruptors ; Estrogens ; Receptors, Estrogen ; Xenobiotics ; Estrone (2DI9HA706A)
Language	English
Publishing date	2022-02-16
Publishing country	United States
Document type	Journal Article ; Research Support, U.S. Gov't, Non-P.H.S.
ZDB-ID	1420885-4
ISSN	1096-0929 ; 1096-6080
ISSN (online)	1096-0929
ISSN	1096-6080
DOI	10.1093/toxsci/kfac019
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