Abstract
Available point mutation tests have shown inconsistent results with various acrylates. Most of those tests were performed prior to OECD guidelines and appropriate data regarding cytotoxicity are not given. Data from three current OECD guideline compliant experiments conducted under GLP are provided. They include (a) an in vitro mouse lymphoma (TK+/−) assay (OECD 490) [3], (b) an in vitro HPRT locus gene mutation assay utilizing cultures of Chinese hamster V79 cells (OECD 476) [1], and (c) an in vitro micronucleus test in human lymphocytes (OECD 487) [2]. Test materials were not mutagenic under these experimental conditions, adding to the weight-of-evidence of non-genotoxicity for this group of chemicals.
Highlights
Sandra Murphy a, Robert Ellis-Hutchings b,n, Lavorgie Finch c, Stefanie Welz d, Karin Wiench d a Kennett Square, PA 19348, United States b The Dow Chemical Company, Midland, MI 48674, United States c Arkema Inc., King of Prussia, PA 19406, United States d BASF SE, Ludwigshafen am Rhein, Germany article info
See method below Studies performed under GLP conditions according the current OECD Test guideline 490 “In Vitro Mammalian Cell Gene Mutation Tests Using the Thymidine Kinase Gene” (Mouse Lymphoma Assay), OECD Test Guideline 476 “In Vitro Mammalian Cell Gene Mutation Tests Using The Hprt and Xprt Genes”(HPRT Test), and OECD Test Guideline 487 “In Vitro Mammalian Cell Micronucleus Test” Using Human Lymphocytes Mouse Lymphoma Assay was conducted at the Experimental Toxicology and Ecology Laboratories of BASF SE, Ludwigshafen, Germany; the HPRT Assay in V79 Cells and in vitro Micronucleus Test were conducted at Envigo CRS GmbH, Rossdorf, Germany Data are provided below
Impact of strain and maximum tolerated dose (MTD) selection in dermal carcinogenicity studies conducted for hazard assessment of non-genotoxic irritants. 2-Ethylhexyl acrylate as a case study
Summary
In vitro genotoxicity studies: n-Butyl acrylate L5178Y mouse lymphoma (TKþ/À locus assay), 2-Ethylhexyl acrylate gene mutation assay in Chinese hamster V79 cells, and 2-Ethylhexyl acrylate micronucleus test in human lymphocytes. Available point mutation tests have shown inconsistent results with various acrylates Most of those tests were performed prior to OECD guidelines and appropriate data regarding cytotoxicity are not given. Data from three current OECD guideline compliant experiments conducted under GLP are provided They include (a) an in vitro mouse lymphoma (TKþ / À ) assay (OECD 490) [3], (b) an in vitro HPRT locus gene mutation assay utilizing cultures of Chinese hamster V79 cells (OECD 476) [1], and (c) an in vitro micronucleus test in human lymphocytes (OECD 487) [2].
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