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5 results

  1. TSRC, Tob. Sci. Res. Conf., 2021, 74, abstr. 05

    Assessment of in vitro toxicities demonstrated by total particulate matter (TPM) generated from current market and research reference standard cigarettes using the Bhas-42 promotor cell transformation assay

    SHUTSKY T.(1); McRAE R.(1); SZELIGA K.(1); BRUCE S.(2); JORDAN K.(1)
    (1) Scientific & Regulatory Affairs, RAI Services Company, Winston-Salem, NC 27102, USA; (2) MilliporeSigma (BioReliance® Toxicology Testing Services), Rockville, MD 20850, USA
    The Bhas 42 cell transformation assay (CTA) has been used to complement standard in vitro testing of tobacco products for understanding downstream biological implications of genetic toxicological changes related to tumor promotion. Investigators have...
  2. TSRC, Tob. Sci. Res. Conf., 2019, 73, abstr. 010

    Qualification of cell line A549 for the neutral red uptake (NRU) assay

    BRUCE S.; GARALA K.; SRINIVASAN D.; SPRINGER S.; DEY D.; CAMPASINO K.; KULKARNI R.
    MilliporeSigma (BioReliance® Toxicology Testing Services), Rockville, MD, USA
    As per 3R, in vitro cytotoxicity tests such as the Neutral Red Update (NRU) assay are routinely used as alternative toxicity tests to eliminate the use of animals for acute oral toxicity tests. The NRU assay is one of the most commonly used...
  3. TSRC, Tob. Sci. Res. Conf., 2019, 73, abstr. 011

    Comparison of vehicle controls for cell line A549 in the neutral red uptake (NRU) assay

    BRUCE S.; GARALA K.; SRINIVASAN D.; SPRINGER S.; DEY D.; CAMPASINO K.; KULKARNI R.
    MilliporeSigma (BioReliance® Toxicology Testing Services), Rockville, MD, USA
    To avoid and minimize acute oral toxicity tests on animals, in vitro cytotoxicity tests such the Neutral Red Uptake (NRU) assay are routinely performed. This assay does not have an OECD test guideline but the ICCVAM protocol and OECD guidance...
  4. TSRC, Tob. Sci. Res. Conf., 2018, 72, abstr. 049

    Assessment of in vitro toxicity/genotoxicity of ends and combustible products

    JORDAN K.(1); BOMBICK B.(1); COOPER B.(1); LEVERETTE R.(1); SHUTSKY T.(1); WEST C.(1); STRASSER J.(1); ROUND E.(1); MARANO K.M.(1); MOMIN R.(2); TRIVEDI A.(2); WAGSTAFF W.(2); BRUCE S.(3); DAKOULAS E.(3); ROY S.(3)
    (1) RAI Services Company, Winston-Salem, NC, USA; (2) Labstat International ULC, Kitchener, ON, Canada; (3) BioReliance Corp, Rockville, MD, USA
    In May 2016, the U.S. Food and Drug Administration Center for Tobacco Products (CTP) issued draft guidance for Premarket Tobacco Product Applications (PMTA) for Electronic Nicotine Delivery Systems (ENDS), which recommends inclusion of in vitro...