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Mutagenicity Tests

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Methodological considerations for using umu assay to assess photo-genotoxicity of engineered nanoparticles.

Mutation research. Genetic toxicology and environmental mutagenesis
In this study we investigated the feasibility of high-throughput (96-well plate) umu assay to test the genotoxic effect of TiO2 engineered nanoparticles (ENPs) under UV light (full spectrum) and visible light (455 nm). Exposure of TiO2 ENPs to up to ...

(Q)SAR assessments of potentially mutagenic impurities: a regulatory perspective on the utility of expert knowledge and data submission.

Regulatory toxicology and pharmacology : RTP
(Quantitative) structure activity relationship [(Q)SAR] modeling is the primary tool used to evaluate the mutagenic potential associated with drug impurities. General recommendations regarding the use of (Q)SAR in regulatory decision making have rece...

Genotoxic mode of action predictions from a multiplexed flow cytometric assay and a machine learning approach.

Environmental and molecular mutagenesis
Several endpoints associated with cellular responses to DNA damage as well as overt cytotoxicity were multiplexed into a miniaturized, "add and read" type flow cytometric assay. Reagents included a detergent to liberate nuclei, RNase and propidium io...

Extending (Q)SARs to incorporate proprietary knowledge for regulatory purposes: A case study using aromatic amine mutagenicity.

Regulatory toxicology and pharmacology : RTP
Statistical-based and expert rule-based models built using public domain mutagenicity knowledge and data are routinely used for computational (Q)SAR assessments of pharmaceutical impurities in line with the approach recommended in the ICH M7 guidelin...

A knowledge-based expert rule system for predicting mutagenicity (Ames test) of aromatic amines and azo compounds.

Toxicology
Cancer is one of the main causes of death in Western countries, and a major issue for human health. Prolonged exposure to a number of chemicals was observed to be one of the primary causes of cancer in occupationally exposed persons. Thus, the develo...