ASTM E1202-1987(2003) Standard Guide for Development of Micronucleus Assay Standards《微核检测标准制定用标准指南》.pdf
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1、Designation: E 1202 87 (Reapproved 2003)Standard Guide forDevelopment of Micronucleus Assay Standards1This standard is issued under the fixed designation E 1202; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of last revi
2、sion. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) indicates an editorial change since the last revision or reapproval.1. Scope1.1 This guide covers minimal criteria which should be metby a micronucleus assay system prior to the development of anASTM Standa
3、rd or Guide for the conduct of that assay.1.2 This standard does not purport to address all of thesafety concerns, if any, associated with its use. It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulator
4、y limitations prior to use.2. Significance and Use2.1 Micronucleus assays for genetic damage have beendeveloped in many types of eucaryotic cells, both in vitro andin vivo. The occurrence of micronuclei is indicative of chro-mosomal damage or mitotic spindle dysfunction.3. Criteria3.1 Biology:3.1.1
5、The biology of the system should be well understoodin terms of (a) cell cycle, (b) metabolic capabilities, (c) cultureor growth conditions, and (d) other factors of importance inmaintaining a reproducible experimental situation. Thereshould be evidence that micronuclei arise from chromosomalaberrati
6、ons or chromosome loss or both, and not apoptosis orany other mechanism.3.2 Time Response:3.2.1 The “expression time” for micronuclei should becharacterized for (a) direct-acting genotoxins and (b) genotox-ins requiring metabolic activation.3.3 Dose Response:3.3.1 The dose response curves for severa
7、l classes ofgenotoxins, over a dose range including both toxic andnontoxic doses, should be known. A rational method fordetermining the upper and lower doses to be tested should beavailable.3.4 Spontaneous Frequency:3.4.1 The spontaneous frequency of micronuclei should bewell characterized and shoul
8、d be stable under the test condi-tions employed. Major factors affecting the spontaneous inci-dence of micronuclei should be defined.3.5 Statistics:3.5.1 The following statistical criteria should be met:3.5.1.1 There should be sufficient data to define the majorsources of experimental variability (f
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