ASTM E1202-87(2003)

Standard Guide for Development of Micronucleus Assay Standards

SIGNIFICANCE AND USE
Micronucleus assays for genetic damage have been developed in many types of eucaryotic cells, both in vitro and in vivo. The occurrence of micronuclei is indicative of chromosomal damage or mitotic spindle dysfunction.
SCOPE
1.1 This guide covers minimal criteria which should be met by a micronucleus assay system prior to the development of an ASTM Standard or Guide for the conduct of that assay.
1.2 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

General Information

• Status: Historical
• Publication Date: 09-Sep-2003
• ICS: 07.100.01 - Microbiology in general
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.16 - Biocompatibility Test Methods

Relations

• Replaces: ASTM E1202-87(1998) - Standard Guide for Development of Micronucleus Assay Standards
• Effective Date: 10-Sep-2003
• Replaced By: ASTM E1202-87(2008) - Standard Guide for Development of Micronucleus Assay Standards (Withdrawn 2013)
• Effective Date: 01-Aug-2008

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:E1202–87(Reapproved 2003)
Standard Guide for
Development of Micronucleus Assay Standards
This standard is issued under the fixed designation E 1202; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3.3.1 The dose response curves for several classes of
genotoxins, over a dose range including both toxic and
1.1 This guide covers minimal criteria which should be met
nontoxic doses, should be known. A rational method for
by a micronucleus assay system prior to the development of an
determining the upper and lower doses to be tested should be
ASTM Standard or Guide for the conduct of that assay.
available.
1.2 This standard does not purport to address all of the
3.4 Spontaneous Frequency:
safety concerns, if any, associated with its use. It is the
3.4.1 The spontaneous frequency of micronuclei should be
responsibility of the user of this standard to establish appro-
well characterized and should be stable under the test condi-
priate safety and health practices and determine the applica-
tions employed. Major factors affecting the spontaneous inci-
bility of regulatory limitations prior to use.
dence of micronuclei should be defined.
2. Significance and Use
3.5 Statistics:
3.5.1 The following statistical criteria should be met:
2.1 Micronucleus assays for genetic damage have been
3.5.1.1 There should be sufficient data to define the major
developed in many types of eucaryotic cells, both in vitro and
sources of experimental variability (for example, slide to slide,
in vivo. The occurrence of micronuclei is indicative of chro-
animal to animal), in order to permit rational experimental
mosomal damage or mitotic spindle dysfunction.
design,
3. Criteria
3.5.1.2 Appropriate statistical methods for analyzing the
data should be available,
3.1 Biology:
3.5.1.3 Sufficient data and adequate statistical methods
3.1.1 The biology of the system should be well understood
should be available to permit determination of the sample sizes
in terms of (a) cell cycle, (b) metabolic capabilities, (c) culture
required for adequate statistical power, and
or growth conditions, and (d) other factors of importance in
3.5.1.4 The quantitative reproducibility of experimental re-
maintaining a reproducible experimental situation. There
sults between and within experiments should be known.
should be evidence that micronuclei arise from chromosomal
3.6 Transportability:
aberrations or chromosome loss o
...