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  1. Article ; Online: The holy grail in genetic toxicology: follow-up approaches for positive results in the Ames assay.

    Aardema, Marilyn J

    Environmental and molecular mutagenesis

    2013  Volume 54, Issue 8, Page(s) 617–620

    Abstract: Positive results in the Ames/E. coli bacterial mutagenicity assay create a significant hurdle for the development of new products/drugs and as a result, most companies drop mutagenic ingredients from further development. One important consequence of this ...

    Abstract Positive results in the Ames/E. coli bacterial mutagenicity assay create a significant hurdle for the development of new products/drugs and as a result, most companies drop mutagenic ingredients from further development. One important consequence of this is that the understanding of the human relevance of chemicals that are positive in the Ames assay is not increasing at the pace seen with ingredients that are positive in the other in vitro genotoxicity assays. Recent advances in defining thresholds for mutagenic carcinogens, along with new assays for measuring mutagenicity in vivo suggests it is time to direct more attention to the holy grail of clearly defining practical approaches to address positive results in the Ames assay. To stimulate further discussion and research in this area, a review of the most current thinking on approaches for dealing with Ames positive results is provided along with some suggestions for the way forward.
    MeSH term(s) Animals ; Carcinogens/toxicity ; Escherichia coli/drug effects ; Humans ; Microbiological Techniques/standards ; Mutagenicity Tests/standards ; Toxicology/methods ; Toxicology/standards
    Chemical Substances Carcinogens
    Language English
    Publishing date 2013-10
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 639145-x
    ISSN 1098-2280 ; 0893-6692
    ISSN (online) 1098-2280
    ISSN 0893-6692
    DOI 10.1002/em.21813
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  2. Article ; Online: A review of mammalian

    Thompson, Chad M / Aardema, Marilyn J / Heintz, Melissa M / MacGregor, James T / Young, Robert R

    Critical reviews in toxicology

    2022  Volume 51, Issue 10, Page(s) 820–849

    Abstract: 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 determination of a ... ...

    Abstract 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 determination of a mutagenic MOA remains elusive, resulting in different estimates of carcinogenic risk for the same chemical among different stakeholders. Oral toxicity criteria for hexavalent chromium [Cr(VI)], for example, differ by orders of magnitude due largely to the interpretation of
    MeSH term(s) Animals ; Carcinogens/toxicity ; Chromium/toxicity ; DNA Damage ; Mammals ; Mice ; Mutagenicity Tests ; Rats ; Risk Assessment
    Chemical Substances Carcinogens ; Chromium (0R0008Q3JB) ; chromium hexavalent ion (18540-29-9)
    Language English
    Publishing date 2022-01-21
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Review
    ZDB-ID 1097071-x
    ISSN 1547-6898 ; 1040-8444
    ISSN (online) 1547-6898
    ISSN 1040-8444
    DOI 10.1080/10408444.2021.2000934
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  3. Article ; Online: Use of the EpiDermTM 3D reconstructed skin micronucleus assay for fragrance materials.

    Thakkar, Yax / Moustakas, Holger / Aardema, Marilyn / Roy, Shambhu / Pfuhler, Stefan / Api, Anne Marie

    Mutagenesis

    2021  Volume 37, Issue 2, Page(s) 89–111

    Abstract: In order to evaluate the utility of the 3D reconstructed skin micronucleus assay (3DRSMN) to assess clastogenic/aneugenic potential of the fragrance chemicals, a set of 22 fragrance materials were evaluated in 3DRSMN assay. These materials evaluated were ...

    Abstract In order to evaluate the utility of the 3D reconstructed skin micronucleus assay (3DRSMN) to assess clastogenic/aneugenic potential of the fragrance chemicals, a set of 22 fragrance materials were evaluated in 3DRSMN assay. These materials evaluated were also evaluated in an in vitro as well as in vivo micronucleus assay, conducted as per Organisation for Economic Co-operation and Development guidelines. The results of the RSMN assay were in 100% agreement with the in vivo micronucleus assay results. From this dataset, 18 materials were positive in an in vitro micronucleus assay but were negative in an in vivo micronucleus assay. All these 18 materials were also concluded to be negative in 3DRSMN assay, stressing the importance of the assay to help minimize misleading positive outcomes from the in vitro assay. Since the highest exposure for fragrances is through the dermal route, the RSMN assay fits the applicability domain for testing. Thus, RSMN assay is an important alternative to animal testing for characterization of the genotoxicity potential of fragrance materials.
    MeSH term(s) Animals ; DNA Damage ; Micronucleus Tests/methods ; Mutagens/toxicity ; Odorants ; Skin
    Chemical Substances Mutagens
    Language English
    Publishing date 2021-11-30
    Publishing country England
    Document type Journal Article
    ZDB-ID 632903-2
    ISSN 1464-3804 ; 0267-8357
    ISSN (online) 1464-3804
    ISSN 0267-8357
    DOI 10.1093/mutage/geab040
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  4. Article ; Online: A weight of evidence review of the genotoxicity of titanium dioxide (TiO

    Kirkland, David / Aardema, Marilyn J / Battersby, Rüdiger V / Beevers, Carol / Burnett, Karin / Burzlaff, Arne / Czich, Andreas / Donner, E Maria / Fowler, Paul / Johnston, Helinor J / Krug, Harald F / Pfuhler, Stefan / Stankowski, Leon F

    Regulatory toxicology and pharmacology : RTP

    2022  Volume 136, Page(s) 105263

    Abstract: Titanium dioxide is a ubiquitous white material found in a diverse range of products from foods to sunscreens, as a pigment and thickener, amongst other uses. Titanium dioxide has been considered no longer safe for use in foods (nano and microparticles ... ...

    Abstract Titanium dioxide is a ubiquitous white material found in a diverse range of products from foods to sunscreens, as a pigment and thickener, amongst other uses. Titanium dioxide has been considered no longer safe for use in foods (nano and microparticles of E171) by the European Food Safety Authority (EFSA) due to concerns over genotoxicity. There are however, conflicting opinions regarding the safety of Titanium dioxide. In an attempt to clarify the situation, a comprehensive weight of evidence (WoE) assessment of the genotoxicity of titanium dioxide based on the available data was performed. A total of 192 datasets for endpoints and test systems considered the most relevant for identifying mutagenic and carcinogenic potential were reviewed and discussed for both reliability and relevance (by weight of evidence) and in the context of whether the physico-chemical properties of the particles had been characterised. The view of an independent panel of experts was that, of the 192 datasets identified, only 34 met the reliability and quality criteria for being most relevant in the evaluation of genotoxicity. Of these, 10 were positive (i.e. reported evidence that titanium dioxide was genotoxic), all of which were from studies of DNA strand breakage (comet assay) or chromosome damage (micronucleus or chromosome aberration assays). All the positive findings were associated with high cytotoxicity, oxidative stress, inflammation, apoptosis, necrosis, or combinations of these. Considering that DNA and chromosome breakage can be secondary to physiological stress, it is highly likely that the observed genotoxic effects of titanium dioxide, including those with nanoparticles, are secondary to physiological stress. Consistent with this finding, there were no positive results from the in vitro and in vivo gene mutation studies evaluated, although it should be noted that to definitively conclude a lack of mutagenicity, more robust in vitro and in vivo gene mutation studies would be useful. Existing evidence does not therefore support a direct DNA damaging mechanism for titanium dioxide (nano and other forms).
    MeSH term(s) Reproducibility of Results ; Metal Nanoparticles/chemistry ; Titanium/toxicity ; Titanium/chemistry ; Comet Assay ; DNA Damage ; Mutagens/toxicity ; DNA
    Chemical Substances titanium dioxide (15FIX9V2JP) ; Titanium (D1JT611TNE) ; Mutagens ; DNA (9007-49-2)
    Language English
    Publishing date 2022-10-11
    Publishing country Netherlands
    Document type Journal Article ; Review
    ZDB-ID 604672-1
    ISSN 1096-0295 ; 0273-2300
    ISSN (online) 1096-0295
    ISSN 0273-2300
    DOI 10.1016/j.yrtph.2022.105263
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  5. Article ; Online: A weight of evidence assessment of the genotoxic potential of 4-methylimidazole as a possible mode of action for the formation of lung tumors in exposed mice.

    Brusick, David / Aardema, Marilyn J / Allaben, William T / Kirkland, David J / Williams, Gary / Llewellyn, G Craig / Parker, Julia M / Rihner, Marisa O

    Food and chemical toxicology : an international journal published for the British Industrial Biological Research Association

    2020  Volume 145, Page(s) 111652

    Abstract: 4-Methylimidazole (4-MeI) is a byproduct formed during the cooking of foods containing carbohydrates and amino acids, including the production of flavors and coloring substances, e.g., class III and IV caramel colors, used in many food products with ... ...

    Abstract 4-Methylimidazole (4-MeI) is a byproduct formed during the cooking of foods containing carbohydrates and amino acids, including the production of flavors and coloring substances, e.g., class III and IV caramel colors, used in many food products with extensive human exposure. Two-year rodent bioassays via oral exposure conducted by the National Toxicology Program reported evidence of carcinogenicity only in B6C3F
    MeSH term(s) Animals ; Cell Line ; Humans ; Imidazoles/toxicity ; Lung Neoplasms/epidemiology ; Mice ; Mutagenicity Tests
    Chemical Substances Imidazoles ; 4-methylimidazole (Q64GF9FV4I)
    Language English
    Publishing date 2020-08-01
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 782617-5
    ISSN 1873-6351 ; 0278-6915
    ISSN (online) 1873-6351
    ISSN 0278-6915
    DOI 10.1016/j.fct.2020.111652
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  6. Article ; Online: Genotoxicity Expert Panel review: weight of evidence evaluation of the genotoxicity of glyphosate, glyphosate-based formulations, and aminomethylphosphonic acid.

    Brusick, David / Aardema, Marilyn / Kier, Larry / Kirkland, David / Williams, Gary

    Critical reviews in toxicology

    2016  Volume 46, Issue sup1, Page(s) 56–74

    Abstract: In 2015, the International Agency for Research on Cancer (IARC) published a monograph concluding there was strong evidence for genotoxicity of glyphosate and glyphosate formulations and moderate evidence for genotoxicity of the metabolite ... ...

    Abstract In 2015, the International Agency for Research on Cancer (IARC) published a monograph concluding there was strong evidence for genotoxicity of glyphosate and glyphosate formulations and moderate evidence for genotoxicity of the metabolite aminomethylphosphonic acid (AMPA). These conclusions contradicted earlier extensive reviews supporting the lack of genotoxicity of glyphosate and glyphosate formulations. The IARC Monograph concluded there was strong evidence of induction of oxidative stress by glyphosate, glyphosate formulations, and AMPA. The Expert Panel reviewed the genotoxicity and oxidative stress data considered in the IARC Monograph, together with other available data not considered by IARC. The Expert Panel defined and used a weight of evidence (WoE) approach that included ranking of studies and endpoints by the strength of their linkage to events associated with carcinogenic mechanisms. Importantly, the Expert Panel concluded that there was sufficient information available from a very large number of regulatory genotoxicity studies that should have been considered by IARC. The WoE approach, the inclusion of all relevant regulatory studies, and some differences in interpretation of individual studies led to significantly different conclusions by the Expert Panel compared with the IARC Monograph. The Expert Panel concluded that glyphosate, glyphosate formulations, and AMPA do not pose a genotoxic hazard and the data do not support the IARC Monograph genotoxicity evaluation. With respect to carcinogenicity classification and mechanism, the Expert Panel concluded that evidence relating to an oxidative stress mechanism of carcinogenicity was largely unconvincing and that the data profiles were not consistent with the characteristics of genotoxic carcinogens.
    Language English
    Publishing date 2016-09-26
    Publishing country England
    Document type Journal Article
    ZDB-ID 1097071-x
    ISSN 1547-6898 ; 1040-8444
    ISSN (online) 1547-6898
    ISSN 1040-8444
    DOI 10.1080/10408444.2016.1214680
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  7. Article ; Online: The EpiDerm™ 3D human reconstructed skin micronucleus (RSMN) assay: Historical control data and proof of principle studies for mechanistic assay adaptations.

    Roy, Shambhu / Kulkarni, Rohan / Hewitt, Nicola J / Aardema, Marilyn J

    Mutation research. Genetic toxicology and environmental mutagenesis

    2016  Volume 805, Page(s) 25–37

    Abstract: The in vitro human reconstructed skin micronucleus (RSMN) assay in EpiDerm™ is a promising novel animal alternative for evaluating genotoxicity of topically applied chemicals. It is particularly useful for assessing cosmetic ingredients that can no ... ...

    Abstract The in vitro human reconstructed skin micronucleus (RSMN) assay in EpiDerm™ is a promising novel animal alternative for evaluating genotoxicity of topically applied chemicals. It is particularly useful for assessing cosmetic ingredients that can no longer be tested using in vivo assays. To advance the use of this test especially for regulatory decision-making, we have established the RSMN assay in our laboratory according to Good Laboratory Practice and following the principles of the OECD test guideline 487 in vitro mammalian cell micronucleus test. Proficiency with the assay was established by correctly identifying direct-acting genotoxins and genotoxins requiring metabolism, as well as non-genotoxic/non-carcinogenic chemicals. We also report the analysis of our historical control data that demonstrate vehicle control and positive control values for %micronuclei in binucleated cells are in the ranges reported previously. Technical issues including evaluating various solvents with both 48h and 72h treatment regimens were investigated. For the first time, mechanistic studies using CREST analysis revealed that the RSMN assay is suitable for distinguishing aneugens and clastogens. Moreover, the assay is also suitable for measuring cytokines as markers for proliferative and toxic effects of chemicals.
    MeSH term(s) Cytokines/metabolism ; DNA Damage/genetics ; Humans ; Micronucleus Tests/methods ; Skin/cytology ; Skin/metabolism
    Chemical Substances Cytokines
    Language English
    Publishing date 2016-07
    Publishing country Netherlands
    Document type Journal Article
    ISSN 1879-3592
    ISSN (online) 1879-3592
    DOI 10.1016/j.mrgentox.2016.05.010
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  8. Article ; Online ; Conference proceedings: Achieving professional success in US government, academia, and industry: an EMGS commentary.

    Poirier, Miriam C / Schwartz, Jeffrey L / Aardema, Marilyn J

    Environmental and molecular mutagenesis

    2014  Volume 55, Issue 7, Page(s) 525–529

    Abstract: One of the goals of the EMGS is to help members achieve professional success in the fields they have trained in. Today, there is greater competition for jobs in genetic toxicology, genomics, and basic research than ever before. In addition, job security ... ...

    Abstract One of the goals of the EMGS is to help members achieve professional success in the fields they have trained in. Today, there is greater competition for jobs in genetic toxicology, genomics, and basic research than ever before. In addition, job security and the ability to advance in one's career is challenging, regardless of whether one works in a regulatory, academic, or industry environment. At the EMGS Annual Meeting in Monterey, CA (September, 2013), the Women in EMGS Special Interest Group held a workshop to discuss strategies for achieving professional success. Presentations were given by three speakers, each representing a different employment environment: Government (Miriam C. Poirier), Academia (Jeffrey L. Schwartz), and Industry (Marilyn J. Aardema). Although some differences in factors or traits affecting success in the three employment sectors were noted by each of the speakers, common factors considered important for advancement included networking, seeking out mentors, and developing exceptional communication skills.
    MeSH term(s) Career Choice ; Employment ; Female ; Government ; Humans ; Industry/manpower ; United States ; Universities/manpower ; Women
    Language English
    Publishing date 2014-08
    Publishing country United States
    Document type Congresses
    ZDB-ID 639145-x
    ISSN 1098-2280 ; 0893-6692
    ISSN (online) 1098-2280
    ISSN 0893-6692
    DOI 10.1002/em.21871
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  9. Article ; Online: Validation of the 3D reconstructed human skin micronucleus (RSMN) assay: an animal-free alternative for following-up positive results from standard in vitro genotoxicity assays.

    Pfuhler, Stefan / Downs, Thomas R / Hewitt, Nicola J / Hoffmann, Sebastian / Mun, Greg C / Ouedraogo, Gladys / Roy, Shambhu / Curren, Rodger D / Aardema, Marilyn J

    Mutagenesis

    2021  Volume 36, Issue 1, Page(s) 1–17

    Abstract: In vitro test batteries have become the standard approach to determine the genotoxic potential of substances of interest across industry sectors. While useful for hazard identification, standard in vitro genotoxicity assays in 2D cell cultures have ... ...

    Abstract In vitro test batteries have become the standard approach to determine the genotoxic potential of substances of interest across industry sectors. While useful for hazard identification, standard in vitro genotoxicity assays in 2D cell cultures have limited capability to predict in vivo outcomes and may trigger unnecessary follow-up animal studies or the loss of promising substances where animal tests are prohibited or not desired. To address this problem, a team of regulatory, academia and industry scientists was established to develop and validate 3D in vitro human skin-based genotoxicity assays for use in testing substances with primarily topical exposure. Validation of the reconstructed human skin micronucleus (RSMN) assay in MatTek Epi-200™ skin models involved testing 43 coded chemicals selected by independent experts, in four US/European laboratories. The results were analysed by an independent statistician according to predefined criteria. The RSMN assay showed a reproducibly low background micronucleus frequency and exhibited sufficient capacity to metabolise pro-mutagens. The overall RSMN accuracy when compared to in vivo genotoxicity outcomes was 80%, with a sensitivity of 75% and a specificity of 84%, and the between- and within-laboratory reproducibility was 77 and 84%, respectively. A protocol involving a 72-h exposure showed increased sensitivity in detecting true positive chemicals compared to a 48-h exposure. An analysis of a test strategy using the RSMN assay as a follow-up test for substances positive in standard in vitro clastogenicity/aneugenicity assays and a reconstructed skin Comet assay for substances with positive results in standard gene mutation assays results in a sensitivity of 89%. Based on these results, the RSMN assay is considered sufficiently validated to establish it as a 'tier 2' assay for dermally exposed compounds and was recently accepted into the OECD's test guideline development program.
    MeSH term(s) Animal Testing Alternatives/methods ; Biological Assay/methods ; DNA Damage ; False Positive Reactions ; Humans ; In Vitro Techniques ; Laboratories/standards ; Micronucleus Tests/methods ; Mutagens/adverse effects ; Skin/drug effects ; Skin/metabolism ; Skin/pathology
    Chemical Substances Mutagens
    Language English
    Publishing date 2021-02-04
    Publishing country England
    Document type Journal Article ; Research Support, Non-U.S. Gov't ; Validation Study
    ZDB-ID 632903-2
    ISSN 1464-3804 ; 0267-8357
    ISSN (online) 1464-3804
    ISSN 0267-8357
    DOI 10.1093/mutage/geaa035
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  10. Article ; Online: The Syrian hamster embryo (SHE) low pH cell transformation assay.

    Pant, Kamala / Aardema, Marilyn J

    Current protocols in toxicology

    2008  Volume Chapter 20, Page(s) Unit20.3

    Abstract: The Syrian hamster embryonic (SHE) cell transformation assay (CTA) at pH 6.7 can determine the ability of a test article to induce morphological transformation (MT) in cultured SHE cells. The assay uses SHE cells prepared at gestation day ∼13 and frozen. ...

    Abstract The Syrian hamster embryonic (SHE) cell transformation assay (CTA) at pH 6.7 can determine the ability of a test article to induce morphological transformation (MT) in cultured SHE cells. The assay uses SHE cells prepared at gestation day ∼13 and frozen. Target cells are seeded onto a layer of feeder cells (X-ray irradiated SHE cells) and treated with test article for 24 hr or 7 days. After a growth period of 7 days, the cells are fixed, stained, and evaluated for MT. Normal colonies typically contain a monolayer of cells with an organized, often flowing, pattern of growth and minimal cell criss-crossing at a confluent density. Transformed colonies contain randomly oriented, stacked cells, with cell criss-crossing throughout the colony. The transformed cells are frequently more basophilic than their normal counterparts, with increased nuclear/cytoplasmic ratios. This assay provides a valuable tool for evaluating the carcinogenic potential of a test article.
    MeSH term(s) Animals ; Carcinogenicity Tests/methods ; Carcinogens/toxicity ; Cell Transformation, Neoplastic ; Cricetinae ; Embryo Culture Techniques/methods ; Embryo, Mammalian/drug effects ; Hydrogen-Ion Concentration ; Mesocricetus
    Chemical Substances Carcinogens
    Language English
    Publishing date 2008-02
    Publishing country United States
    Document type Journal Article
    ISSN 1934-9262
    ISSN (online) 1934-9262
    DOI 10.1002/0471140856.tx2003s35
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