Contribution to regulatory science and a next challenge of the Japanese Environmental Mutagen Society (JEMS)
Tóm tắt
Many members of The Japanese Environmental Mutagen Society (JEMS) have significantly contributed to guidelines on chemical genotoxicity. The guidelines have been useful for the hazard identification and risk assessment of genotoxic chemicals. However, risk assessors and developers of drugs and other commercial products might eliminate beneficial chemicals from further development simply based on positive results of genotoxicity testing. Experts in the field of genotoxicity should better characterize the biological significance of genotoxicants and more correctly assess human risk. I hope that one of the next challenges undertaken by JEMS will be to assess the human risk of genotoxic chemicals more correctly based on the precise analysis of their mechanisms of action.
Tài liệu tham khảo
OECD, TG471: OECD guideline for the testing of chemicals. Bacterial Reverse Mutation Test. Adopted on 26 May 1983, updated on 21 July 1997.
OECD, TG473: OECD guideline for the testing of chemicals. In vitro Mammalian Chromosome Aberration Test. Adopted on 26 May 1983, updated on 21 July 1997 and 26 September 2014.
OECD, TG474: OECD guideline for the testing of chemicals. In vivo Mammalian Erythrocyte Micronucleus Test. Adopted on 26 May 1983, updated on 21 July 1997 and 26 September 2014.
OECD, TG475: OECD guideline for the testing of chemicals. In vivo Mammalian Bone Marrow Chromosome Aberration Test. Adopted on 4 April 1984, updated on 21 July 1997 and 26 September 2014.
OECD, TG476: OECD guideline for the testing of chemicals. In vitro Mammalian Cell Gene Mutation Test. Adopted on 4 April 1984, updated on 21 July 1997 and 28 July 2015.
OECD, TG478: OECD guideline for the testing of chemicals. Genetic Toxicology: Rodent Dominant Lethal Test. Adopted on 4 April 1984, updated on 28 July 2015.
OECD, TG483: OECD guideline for the testing of chemicals. Mammalian Spermatagonial Chromosomal Aberration Test. Adopted on 23 October 1986, updated on 21 July 1997 and 28 July 2015.
OECD, TG485: OECD guideline for the testing of chemicals. Genetic Toxicology: Mouse Heritable Translocation Assay. Adopted on 23 October 1986.
OECD, TG486: OECD guideline for the testing of chemicals. Unscheduled DNA Synthesis (UDS) Test with Mammalian Liver Cells in vivo. Adopted on 21 July 1997.
OECD, TG487: OECD guideline for the testing of chemicals. In vitro Mammalian Cell Micronucleus Test. Adopted on 22 July 2010, updated on 26 September 2014.
OECD, TG488: OECD guideline for the testing of chemicals. Transgenic Rodent Somatic and Germ Cell Gene Mutation Assays. Adopted on 28 July 2011, updated on 26 July 2013.
OECD, TG489: OECD guideline for the testing of chemicals. In vivo Mammalian Alkaline Comet Assay. Adopted on 22 September 2014.
OECD, TG492: OECD guideline for the testing of chemicals. In vitro Thymidine Kinase Mutation Test. Adopted on 28 July 2015.
International Conference on Harmonization of Technical Requirement for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline. S2A: Guidance on specific aspects of regulatory genotoxicity tests for pharmaceuticals. Approved on 19 July 1995.
International Conference on Harmonization of Technical Requirement for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline. S2B: Genotoxicity: a standard battery for genotoxicity testing of pharmaceuticals. Approved on 16 July 1997.
International Conference on Harmonization of Technical Requirement for Registration of Pharmaceuticals for Human Use. ICH Harmonized Tripartite Guideline. S2(R1): Guidance on genotoxicity testing and data interpretation for pharmaceuticals intended for human use. Approved on 9 November 2011.
Uno Y. Understanding of genotoxic mechanism of action for carcinogen risk assessment to humans; a commentary to the discussion at the 4th International Workshop on Genotoxicity Testing (IWGT). Genes Environ. 2006;28:38–9.
Kanaly RA, Hanaoka T, Sugimura H, Toda H, Matsui S, Matsuda T. Development of the adductome approach to detect DNA damage in humans. Antioxid Redox Signal. 2006;8:993–1001.
Kirkland D, Aardema M, Henderson L, Müller L. Evaluation of the ability of a battery of 3 in vitro genotoxicity tests to discriminate rodent carcinogens and non-carcinogens. I. Sensitivity, specificity and relative predictivity. Mutat Res. 2005;584:1–256.
Kato K, Yamamura E, Kawanishi M, Yagi T, Matsuda T, Sugiyama A, Uno Y. Application of the DNA adductome approach to assess the DNA-damaging capability of in vitro micronucleus test-positive compounds. Mutat Res. 2011;721:21–6.
Egi Y, Matsuura S, Maruyama T, Fujio M, Yuki S, Akira T. Neuroprotective effects of a novel water-soluble poly(ADP-ribose)polymerase-1 inhibitor MP-124 in in vitro and in vivo models of cerebral ischemia. Brain Res. 2011;1389:169–76.
Matsuura S, Egi Y, Yuki S, Horikawa T, Satoh H, Akira T. MP-124 a novel poly(ADP-ribose)polymerase-1 (PARP-1) inhibitor ameliorates ischemic brain damage in a non-human primate model. Brain Res. 2011;1410:122–31.
Satoh MS, Lindahl T. Role of poly(ADP-ribose) formation in DNA repair. Nature. 1992;356:356–8.
Lindahl T, Sato MS, Poirier GG, Klungland A. Post-translational modification of poly(ADP-ribose) polymerase induced by DNA strand breaks. Trends Biochem Sci. 1995;20:405–11.
Rhun YL, Kirkland JB, Shah GM. Cellular responses to DNA damage in the absence of poly(ADP-ribose) polymerase. Biochem Biophys Res Commun. 1998;245:1–10.
D'Amours D, Desnoyers S, D'Silva I, Poirier GG. Poly(ADP-ribosyl)ation reactions in the regulation of nuclear functions. Biochem J. 1999;342:249–68.
Herceg Z, Wang ZQ. Functions of poly(ADP-ribose) polymerase (PARP) in DNA repair, genomic integrity and cell death. Mutat Res. 2001;477:97–110.
Yamamura E, Muto S, Yamada K, Sato Y, Iwase Y, Uno Y. Chromosomal damage and micronucleus induction by MP-124, a novel poly(ADP-ribose)polymerase-1 (PARP-1) inhibitor: Evidence for a non-DNA-reactive mode of action. Mutat Res. 2015;782:1–8.