Summary of Health and Safety Test Results - Invitrogen

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4 Born to Be Wild-Type. Genotoxicity Results Conclusion SYBR Safe DNA gel stain does not induce transformations in primary cultures of Syrian hamster embryo (SHE) cells when compared with solvent alone, strongly indicating that the SYBR Safe stain is noncarcinogenic. In contrast, ethidium bromide tests positive in the SHE assay, consistent with its known activity as a strong mutagen. Summary of Results An independent laboratory investigated the ability of SYBR Safe DNA stain for inducing an increase in morphological transformation of Syrian hamster embryo (SHE) cells, relative to vehicle control cultures, following a 7-day exposure period. None of the three treatment groups (0.0500, 0.150, and 0.300 μg/ml) induced a signifi cant increase in morphological transformation compared to the concurrent vehicle control. In addition, a signifi cant increase of the morphological transformation frequency was also obtained from the positive control treatment with benzo α pyrene at 5.0 mg/ml. The test article (SYBR Safe stain) was therefore evaluated as negative in the screening SHE cell transformation assay under 7-day exposure conditions of this study. Table 1. SYBR Safe stain—Mammalian genotoxicity analysis Conclusion SYBR Safe DNA gel stain does not cause mutations in mouse lymphoma cells at the TK locus, nor does it induce chromosomal aberrations in cultured human peripheral blood lymphocytes, with or without S9 metabolic activation, using standardized tests against appropriate controls. Summary of Results An independent laboratory investigated the ability of SYBR Safe DNA gel stain to induce chromosomal aberrations in cultured peripheral blood lymphocytes with and without exogenous metabolic activation. No signifi cant increases in the number of cells with structural aberrations, polyploidy, or endoreduplication were observed in test either with or without S9 activation. Similarly, no increases in the mutant frequency were observed that exceeded the minimum criteria in L5178Y TK+/- mouse lymphoma cells. In In In Vitro Vitro Vitro Test * Cell Type Result with S9 Activation † Result without S9 Activation † Transformation 1 Syrian hamster embryo (SHE) cells NA Negative Chromosomal aberrations 2 Cultured human peripheral blood lymphocytes Negative Negative Forward mutation 3,4 L5178YTK+/- mouse lymphoma cells Negative Negative * In vitro tests were performed by Covance Laboratories Inc., Vienna, VA. † Mammalian S9 fraction obtained from Aroclor 1254–induced rat liver. NA = Not applicable. 1. Fundamental and Molecular Mechanisms of Mutagenesis 356, 1 (1996); 2. Evans, H.J., in Chemical Mutagens, Principles and Methods for Their Detection, A. Hollaender, Ed., Vol. 4, (1976) pp. 1–29; 3. Mutation Res 72, 447 (1980); 4. Mutation Res 59, 61 (1979). Important Licensing Information These products may be covered by one or more Limited Use Label Licenses (see the Invitrogen website, www.invitrogen.com, or the Molecular Probes website, probes.invitrogen.com). By use of these products you accept the terms and conditions of all applicable Limited Use Label Licenses. All products are for research use only. CAUTION: Not intended for human or animal diagnostic or therapeutic uses.
Conclusion Compared to ethidium bromide, SYBR Safe DNA gel stain causes fewer mutations in the standard Ames test, as mea- sured in several diff erent strains of Salmonella typhimurium. Weakly positive results for SYBR Safe DNA gel stain in this test occurred in four out of seven strains and only with activation by a mammalian S9 fraction (see fi gure). Summary of Results Samples were pretreated with a mammalian S9 fraction and then tested. With S. S. S. typhimurium typhimurium typhimurium strains TA97a, TA98, TA100 and TA102, an increase in revertants of more than twofold over background indicates a positive result for mutagenicity in this test. With strains TA1535, TA1537 and TA1538, an increase in revertants of more than threefold over background indicates a positive result. We Like You Just the Way You Are. Toxicity Results Conclusion A single oral administration of SYBR Safe DNA gel stain produces no signs of mortality or toxicity at a limit dose of 5000 mg/kg. Table 2. SYBR Safe stain—Toxicity analysis Analysis Method Results Aquatic toxicity * Fathead minnow CA Title 22 acute screening Oral toxicity ** EPA Acute Oral Toxicity Test OPPTS 870.1100 Not hazardous or toxic to aquatic life LD50 > 5000 mg/kg * Performed by AMEC Earth and Environmental San Diego Bioassay Laboratory, San Diego, CA. ** Peformed by Northview Pacifi c Laboratories, Inc., Hercules, CA. Important Licensing Information These products may be covered by one or more Limited Use Label Licenses (see the Invitrogen website, www.invitrogen.com, or the Molecular Probes website, probes.invitrogen.com). By use of these products you accept the terms and conditions of all applicable Limited Use Label Licenses. All products are for research use only. CAUTION: Not intended for human or animal diagnostic or therapeutic uses. Fold above background 80 60 40 20 0 SYBR Safe Stain EtBr TA97a TA98 TA100 TA102 TA1535 TA1537 TA1538 Ames test strain SYBR Safe DNA Gel Stain SYBR Safe DNA gel stain vs. ethidium bromide—Ames test results. Tests were performed by Covance Laboratories Inc., Vienna, VA. Summary of Results A single oral administration of SYBR Safe DNA gel stain in 0.5X TBE at a limit dose of 5000mg/kg to three female rats produced no mortalities or toxic signs. The procedure is designed to determine that acute oral toxicity of the material under test. A Limit Screen test was performed using three female Sprague Dawley rats, which received an oral limit dose of 5000 mg/kg of SYBR Safe DNA gel stain. The animals were observed for mortality, weight change, and toxic signs for a two-week period. Since all three rats survived for two weeks after the dose administration, the LD50 for the test article was considered to be greater than the Limit Dose and no additional testing was required. w w w.invitrogen.com | probes.invitrogen.com 5
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