Evaluation of the genotoxicity of the food additive, gum ghatti

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• 作者：Cheryl A. Hobbs^a ; ^{cahobbsriter@bellsouth.net} ; ^{chobbs@ils-inc.com} ; Carol Swartz^a ; Robert Maronpot^b ; Jeffrey Davis^c ; Leslie Recio^a ; Shim-mo Hayashi^d
• 关键词：CHO ; Chinese hamster ovary ; FDA ; US Food and Drug Administration ; GLP ; Good Laboratory Practice ; ICH ; International Conference on Harmonization ; JaCVAM ; Japanese Center for the Validation of Alternative Methods ; JECFA ; Joint FAO/WHO Expert Committee on Fo
• 刊名：Food and Chemical Toxicology
• 出版年：2012
• 期刊代码：20_02786915
• 类别：pha
• 出版时间：March-April, 2012
• 卷：50
• 期：3-4
• 页码：854-860
• 文件大小：214 K

摘要

Gum ghatti is a food additive in some parts of the world, serving as an emulsifier, a stabilizer, and a thickening agent. To evaluate its genotoxic potential, we conducted Good Laboratory Practice compliant in vitro and in vivo studies in accordance with the Organisation for Economic Co-operation and Development (OECD) guidelines. No evidence of toxicity or mutagenicity was detected in a bacterial reverse mutation assay using five tester strains evaluating gum ghatti at up to 6 mg/plate, with or without metabolic activation. Gum ghatti also did not induce chromosome structural damage in a chromosome aberration assay using Chinese hamster ovary cells. To assess the ability to induce DNA damage in rodents, a combined micronucleus/Comet assay was conducted in male B6C3F1 mice. Gum ghatti was administered at 1000, 1500, and 2000 mg/kg/day by gavage once daily for 4 days and samples were collected 4 h after the final dosing. No effect of gum ghatti was measured on micronucleated reticulocyte (MN-RET) frequency in peripheral blood, or DNA damage in blood leukocytes or liver as assessed by the Comet assay. Our results show no evidence of genotoxic potential of gum ghatti administered up to the maximum concentrations recommended by OECD guidelines.