James T. MacGregor
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View article: A proposed screening strategy for evaluating the genotoxicity potential of botanicals and botanical extracts
A proposed screening strategy for evaluating the genotoxicity potential of botanicals and botanical extracts Open
Botanicals have long been used to promote health and treat diseases, but the safety of many currently marketed botanicals has not been adequately evaluated. Given the chemical complexity of botanicals, which often contain numerous unknown …
View article: A review of mammalian<i>in vivo</i>genotoxicity of hexavalent chromium: implications for oral carcinogenicity risk assessment
A review of mammalian<i>in vivo</i>genotoxicity of hexavalent chromium: implications for oral carcinogenicity risk assessment Open
Assessment of genotoxicity is a critical component of mode of action (MOA) analysis and carcinogen risk assessment due to its influence on quantitative risk extrapolation approaches. To date, clear guidance and expert consensus on the dete…
View article: Assessment of systemic genetic damage in pediatric inflammatory bowel disease
Assessment of systemic genetic damage in pediatric inflammatory bowel disease Open
The etiology of distal site cancers in inflammatory bowel disease (IBD) is not well understood and requires further study. We investigated whether pediatric IBD patients' blood cells exhibit elevated levels of genomic damage by measuring t…
View article: Human blood <scp><i>PIG‐A</i></scp> mutation and micronucleated reticulocyte flow cytometric assays: Method optimization and evaluation of intra‐ and inter‐subject variation
Human blood <span><i>PIG‐A</i></span> mutation and micronucleated reticulocyte flow cytometric assays: Method optimization and evaluation of intra‐ and inter‐subject variation Open
We previously described flow cytometry‐based methods for scoring the incidence of micronucleated reticulocytes (MN‐RET) and PIG‐A mutant phenotype reticulocytes (MUT RET) in rodent and human blood samples. The current report describes impo…
View article: 3Rs friendly study designs facilitate rat liver and blood micronucleus assays and <i>Pig‐a</i> gene mutation assessments: Proof‐of‐concept with 13 reference chemicals
3Rs friendly study designs facilitate rat liver and blood micronucleus assays and <i>Pig‐a</i> gene mutation assessments: Proof‐of‐concept with 13 reference chemicals Open
Regulatory guidance documents stress the value of assessing the most appropriate endpoints in multiple tissues when evaluating the in vivo genotoxic potential of chemicals. However, conducting several independent studies to evaluate multip…
View article: <i>In vivo pig‐a</i> and micronucleus study of the prototypical aneugen vinblastine sulfate
<i>In vivo pig‐a</i> and micronucleus study of the prototypical aneugen vinblastine sulfate Open
The Pig‐a assay is being used in regulatory studies to evaluate the potential of agents to induce somatic cell gene mutations and an OECD test guideline is under development. A working group involved with establishing the guideline recentl…
View article: Rat Pig-a mutation assay responds to the genotoxic carcinogen ethyl carbamate but not the non-genotoxic carcinogen methyl carbamate
Rat Pig-a mutation assay responds to the genotoxic carcinogen ethyl carbamate but not the non-genotoxic carcinogen methyl carbamate Open
Determination of the mode of action of carcinogenic agents is an important factor in risk assessment and regulatory practice. To assess the ability of the erythrocyte-based Pig-a mutation assay to discriminate between genotoxic and non-gen…
View article: Comparison of male versus female responses in the Pig-a mutation assay
Comparison of male versus female responses in the Pig-a mutation assay Open
Validation of the Pig-a gene mutation assay has been based mainly on studies in male rodents. To determine if the mutagen-induced responses of the X-linked Pig-a gene differ in females compared to males, 7- or 14-week old male and female S…
View article: Induction of Pig-a mutant erythrocytes in male and female rats exposed to 1,3-propane sultone, ethyl carbamate, or thiotepa
Induction of Pig-a mutant erythrocytes in male and female rats exposed to 1,3-propane sultone, ethyl carbamate, or thiotepa Open