[1] DISHOTSKY N I, LOUGHMAN W D, MOGAR R E, et al. LSD and genetic damage[J]. Science, 1971, 172(3982): 431-440. [2] SNYDER R D, GREEN J W. A review of the genotoxicity of marketed pharmaceuticals[J]. Mutat Res, 2001, 488(2): 151-169. [3] 王亚楠, 王雪, 汪祺, 等. 基于毒理学软件和细菌回复突变试验的大黄素型蒽醌基因突变风险评价[J]. 药物评价研究, 2022, 45(7): 1240-1247. [4] RESENDE F A, VILEGAS W, DOS SANTOS L C, et al. Mutagenicity of flavonoids assayed by bacterial reverse mutation (Ames) test[J]. Molecules, 2012, 17(5): 5255-5268. [5] MULLER H J. Artificial transmutation of the gene[J]. Science, 1927, 66(1699): 84-87. [6] BESSMAN M J, LEHMAN I R, SIMMS E S, et al. Enzymatic synthesis of deoxyribonucleic acid. II. General properties of the reaction[J]. J Biol Chem, 1958, 233(1): 171-177. [7] KIRSCH-VOLDERS M, AARDEMA M, ELHAJOUJI A. Concepts of threshold in mutagenesis and carcinogenesis[J]. Mutat Res, 2000, 464(1): 3-11. [8] PLO-NIK A, VRA-KO M, DOLENC M S. Mutagenic and carcinogenic structural alerts and their mechanisms of action[J]. Arh Hig Rada Toksikol, 2016, 67(3): 169-182. [9] HANSEN K, MIKA S, SCHROETER T, et al. Benchmark data set for in silico prediction of Ames mutagenicity[J]. J Chem Inf Model, 2009, 49(9): 2077-2081. [10] VIAN M, RAITANO G, RONCAGLIONI A, et al. In silico model for mutagenicity (Ames test), taking into account metabolism[J]. Mutagenesis, 2019, 34(1): 41-48. [11] ICH. Guidance on Nonclinical Safety Studies for the Conduct of Human Clinical Trials and Marketing Authorization for Pharmaceuticals [EB/OL]. (2017-02-15) https: //database.ich.org/sites/default/files/M3_R2_Guideline.pdf. [12] GOCKE E, MüLLER L. In vivo studies in the mouse to define a threshold for the genotoxicity of EMS and ENU[J]. Mutat Res, 2009, 678(2): 101-107. [13] JOHNSON G E, DOBO K, GOLLAPUDI B, et al. Permitted daily exposure limits for noteworthy N-nitrosamines[J]. Environ Mol Mutagen, 2021, 62(5): 293-305. [14] ASHBY J. Fundamental structural alerts to potential carcinogenicity or noncarcinogenicity[J]. Environ Mutagen, 1985, 7(6): 919-921. [15] PéREZ-GARRIDO A, HELGUERA A M, RODRíGUEZ F G, et al. QSAR models to predict mutagenicity of acrylates, methacrylates and alpha, beta-unsaturated carbonyl compounds[J]. Dent Mater, 2010, 26(5): 397-415. [16] AMBERG A, HARVEY J S, CZICH A, et al. Do carboxylic/sulfonic acid halides really present a mutagenic and carcinogenic risk as impurities in final drug products-[J]. Org Process Res Dev, 2015, 19(11): 1495-1506. [17] ALVES V, MURATOV E, CAPUZZI S, et al. Alarms about structural alerts[J]. Green Chem, 2016, 18(16): 4348-4360. [18] WANG E Y, HUANG Y, DU Q Y, et al. Silver nanoparticle induced toxicity to human sperm by increasing ROS(reactive oxygen species) production and DNA damage[J]. Environ Toxicol Pharmacol, 2017, 52: 193-199. [19] KIRKLAND D, ZEIGER E, MADIA F, et al. Can in vitro mammalian cell genotoxicity test results be used to complement positive results in the Ames test and help predict carcinogenic or in vivo genotoxic activity-I. Reports of individual databases presented at an EURL ECVAM Workshop[J]. Mutat Res Genet Toxicol Environ Mutagen, 2014, 775/776: 55-68. [20] ZELLER A, BRIGO A, BRINK A, et al. Genotoxicity assessment of drug metabolites in the context of MIST and beyond[J]. Chem Res Toxicol, 2020, 33(1): 10-19. [21] KIRKLAND D, LEVY D D, LEBARON M J, et al. A comparison of transgenic rodent mutation and in vivo comet assay responses for 91 chemicals[J]. Mutat Res Genet Toxicol Environ Mutagen, 2019, 839: 21-35. [22] LUAN Y, XING G Z, QI X M, et al. The application of hepatic P450 reductase null gpt delta mice in studying the role of hepatic P450 in genotoxic carcinogen 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone-induced mutagenesis[J]. Arch Toxicol, 2012, 86(11): 1753-1761. [23] NISHIMURA J, MURAKAMI Y, KINOSHITA T. Paroxysmal nocturnal hemoglobinuria: an acquired genetic disease[J]. Am J Hematol, 1999, 62(3): 175-182. [24] DERTINGER S D, PHONETHEPSWATH S, WELLER P, et al. Interlaboratory pig-a gene mutation assay trial: studies of 1, 3-propane sultone with immunomagnetic enrichment of mutant erythrocytes[J]. Environ Mol Mutagen, 2011, 52(9): 748-755. [25] 李若婉, 周长慧, 黄鹏程, 等. 基于TK6细胞的体外PIG-A基因突变检测方法的建立[J]. 癌变·畸变·突变, 2019, 31(3): 242-248. [26] BEMIS J C, HEFLICH R H. in vitro mammalian cell mutation assays based on the pig-a gene: a report of the 7th international workshop on genotoxicity testing (IWGT) workgroup[J]. Mutat Res Genet Toxicol Environ Mutagen, 2019, 847: 403028. [27] SCHMITT M W, KENNEDY S R, SALK J J, et al. Detection of ultra-rare mutations by next-generation sequencing[J]. Proc Natl Acad Sci U S A, 2012, 109(36): 14508-14513. [28] HOANG M L, KINDE I, TOMASETTI C, et al. Genome-wide quantification of rare somatic mutations in normal human tissues using massively parallel sequencing[J]. Proc Natl Acad Sci USA, 2016, 113(35): 9846-9851. [29] ABASCAL F, HARVEY L M R, MITCHELL E, et al. Somatic mutation landscapes at single-molecule resolution[J]. Nature, 2021, 593(7859): 405-410. [30] YOU X Y, THIRUPPATHI S, LIU W Y, et al. Detection of genome-wide low-frequency mutations with Paired-End and Complementary Consensus Sequencing (PECC-Seq) revealed end-repair-derived artifacts as residual errors[J]. Arch Toxicol, 2020, 94(10): 3475-3485. |