Valentine O. Wagner

Bacterial mutagenicity assays: Vehicle and positive control results from the standard Ames assay, the 6‐ and 24‐well miniaturized plate incorporation assays and the Ames II™ assay

Kamala Pant, Shannon Wilson Bruce, Jamie E. Sly, Michelle Klug Laforce et autres

Bacterial mutation assays are conducted routinely as part of the safety assessment of new chemicals. The OECD Test Guideline (TG) 471 describes the conduct of the standard agar plate Ames assay, required for regulatory submissions. Higher throughput non-OECD 471 TG assays, such …

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Safety evaluation of the human-identical milk monosaccharide sialic acid (N-acetyl-d-neuraminic acid) in Sprague-Dawley rats

Sharon S.H. Choi, Nigel J. Baldwin, Valentine O. Wagner, Shambhu K. Roy et autres

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Genetic Toxicology

Robert Young, Marilyn J. Aardema, Valentine O. Wagner, Jane Clarke et autres

Potential exposure to toxic materials is greater via inhalation than any other route. This potential is due to the large lung surface area available for gas transport (∼90 m2 in an adult human) and the relative ease of passage from alveolus to …

Summary of in vitro genetic toxicology assay results: Expected and unexpected effects of recent study design modifications

Jane J. Clarke, Timothy E. Lawlor, Wannie Madraymootoo, Kamala Pant et autres

Key modifications to in vitro genetic toxicology testing have been made in the last 5 years including the use of optimization approaches such as structure-activity relationships and screening assays to identify and eliminate potentially genotoxic chemicals from further consideration, better guidance on …

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Genotoxic assessment and toxicity evaluation of peginesatide in CByB6F1 hybrid mice

Kathryn W. Woodburn, Peter J. Schatz, Susan D. Wilson, K L Fong et autres

Peginesatide is a PEGylated, investigational, peptide-based erythropoiesis-stimulating agent (ESA) that was designed and engineered to stimulate specifically the erythropoietin receptor dimer that governs erythropoiesis. Clinical use of peginesatide is anticipated to result in chronic dosing in chronic kidney disease (CKD) patients, and …

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Genetic Toxicology

Donald L. Putman, Jane J. Clarke, Patricia A. Escobar, Ramadevi Gudi et autres

Acute exposure may be defined as exposure to a toxicant for a short period, usually less than 24 hours. Toxicity tests designed to explore adverse chemical effects following brief exposures are useful in classifying toxic agents, protecting workers, safeguarding the community against …

Acute, Subchronic, and Mutagenicity Studies with Norbornene Fluoroalcohol

Michael P. DeLorme, Gregory S. Ladics, Erica Donner, Valentine O. Wagner et autres

The object of this study was to evaluate the toxicity of norbornene fluoroalcohol (NBFOH), which is used as an intermediate in the production of fluorinated monomers and polymers. NBFOH was evaluated for acute oral, dermal, and inhalation toxicity, dermal sensitization using the …

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Pharmacological and Toxicological Evaluation of 2-Fluoro-3-(2(S)-azetidinylmethoxy)pyridine (2-F-A-85380), a Ligand for Imaging Cerebral Nicotinic Acetylcholine Receptors with Positron Emission Tomography

D. Bruce Vaupel, Srihari R. Tella, David L. Huso, Valentine O. Wagner et autres

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d-Methylphenidate is non-genotoxic in in vitro and in vivo assays

Steve K. Teo, Richard H.C. San, Valentine O. Wagner, Ramadevi Gudi et autres

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Pharmacology, toxicology, and radiation dosimetry evaluation of [123I]5‐I‐A‐85380, a radioligand for in vivo imaging of cerebral neuronal nicotinic acetylcholine receptors in humans

D. Bruce Vaupel, Srihari R. Tella, David L. Huso, Alexey G. Mukhin et autres

Abstract [123I]5‐I‐A‐85380, which selectively binds to α4β2 nicotinic acetylcholine receptors, may be a suitable single photon emission computed tomography (SPECT) ligand for imaging nicotinic receptors in the human brain. In a mutagenicity study, 5‐I‐A‐85380 produced positive effects in one of five bacterial …

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Mutagenicity of emissions from a natural gas fueled truck

Charles A. Lapin, Mridul Gautam, Barbara Zielińska, Valentine O. Wagner et autres

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Genetic Toxicology

Richard H.C. San, Ramadevi Gudi, Valentine O. Wagner, Robert R. Young et autres