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GB/T 21793-2025: Chemicals - Test method of in vitro mammalian cell gene mutation
Status: Valid GB/T 21793: Evolution and historical versions
| Standard ID | Contents [version] | USD | STEP2 | [PDF] delivered in | Standard Title (Description) | Status | PDF |
| GB/T 21793-2025 | English | 279 |
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Chemicals - Test method of in vitro mammalian cell gene mutation
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GB/T 21793-2025
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| GB/T 21793-2008 | English | 229 |
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Chemicals -- Test method of in vitro mammalian cell gene mutation
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GB/T 21793-2008
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Basic data | Standard ID | GB/T 21793-2025 (GB/T21793-2025) | | Description (Translated English) | Chemicals - Test method of in vitro mammalian cell gene mutation | | Sector / Industry | National Standard (Recommended) | | Classification of Chinese Standard | A80 | | Classification of International Standard | 13.300 | | Word Count Estimation | 14,199 | | Date of Issue | 2025-08-29 | | Date of Implementation | 2025-12-01 | | Older Standard (superseded by this standard) | GB/T 21793-2008 | | Issuing agency(ies) | State Administration for Market Regulation, National Standardization Administration | GB/T 21793-2025: Chemicals - Test method of in vitro mammalian cell gene mutation---This is an excerpt. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.), auto-downloaded/delivered in 9 seconds, can be purchased online: https://www.ChineseStandard.net/PDF.aspx/GBT21793-2025
ICS 13.300
CCSA80
National Standard of the People's Republic of China
Replaces GB/T 21793-2008
Chemicals In vitro mammalian cells
Gene mutation test methods
Released on August 29, 2025
Implementation on December 1, 2025
State Administration for Market Regulation
The National Standardization Administration issued
Preface
This document is in accordance with the provisions of GB/T 1.1-2020 "Guidelines for standardization work Part 1.Structure and drafting rules for standardization documents"
Drafting.
This document replaces GB/T 21793-2008 "Chemicals in vitro mammalian cell gene mutation test method" and GB/T 21793-
Compared with.2008, in addition to structural adjustments and editorial changes, the main technical changes are as follows.
--- Added some content in terms and definitions (see 3.1, 3.9, 3.10, 3.11, 3.12, 3.13, 3.14, 3.15, 3.16, 3.17,
3.18, 3.19);
--- Added abbreviations (see Chapter 4);
--- Deleted the principles of TK mutation detection (see 3.1 of the.2008 edition) and the steps of TK mutation detection (see 3.1 of the.2008 edition)
4.3.2.2, 4.3.2.3);
--- Deleted the chemicals that can be used as positive controls corresponding to the TK site (see 4.2.3.2 of the.2008 edition);
--- Changed some of the contents in the "Solvents/Excipients" regulations, and made some adjustments to the establishment of solvents/excipients and test substance concentration ranges.
Supplement (see 5.2.1, 4.2.1 of the.2008 edition);
--- Added general principles for the frequency of spontaneous mutations during test substance treatment (see 5.3.1.2);
--- Added phenotypic expression time and mutation frequency detection (see 5.3.2);
--- Increased laboratory testing capabilities (see 5.3.3);
--- Added historical comparison data (see 5.3.4);
--- Added test data acceptance criteria (see 6.2);
--- Changed the judgment criteria for negative and positive test results in result evaluation and interpretation (see 6.3.1, 6.3.2, 6.3.3, 6.3.4, 6.3.5,
5.2 of the.2008 edition);
--- Added calculation formulas for cytotoxicity and cell mutation frequency (see Appendix A).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed and coordinated by the National Technical Committee for Standardization of Hazardous Chemicals Management (SAC/TC251).
This document was drafted by. Institute of Occupational Health and Poison Control, Chinese Center for Disease Control and Prevention, North China University of Technology, and China Inspection and Quarantine (Tianjin)
Inspection and Testing Co., Ltd.
The main drafters of this document are. Wang Weixuan, Zhang Yanshu, Hao Han, Li Bin, Zhang Yi, Chen Xiao, Xiao Jingwei, Li Yifei, and Ma Xiuling.
The previous versions of this document and the documents it replaces are as follows.
---First published in.2008 as GB/T 21793-2008;
---This is the first revision.
introduction
In vitro mammalian gene mutation assays can be used to detect chemical-induced gene mutations. Cell lines that can be used include Chinese hamster cells.
CHO, CHL and V79 cell lines, mouse lymphoma cells L5178Y and human lymphoblastoid cells TK6, CHO-derived AS52 cells
In these cell lines, the most commonly used genetic mutation detection indicator is the detection of hypoxanthine-guanine phosphoribosyltransferase
HPRT mutation and xanthine-guanine phosphoribosyltransferase (XPRT) gene mutation.
XPRT is located on the autosomes and can detect genetic mutations that HPRT (located on the X chromosome) cannot detect, such as
Fragment missing.
In in vitro mammalian cell gene mutation tests, established cell lines or cell strain cultures can be used.
Cells are selected based on their growth ability and spontaneous mutation rate. In vitro experiments usually require an exogenous metabolic activation system.
The metabolic activation system cannot fully simulate the metabolic conditions in mammals, so measures are taken to avoid the occurrence of gene mutations that cannot reflect the in vivo
Changes in pH and osmotic pressure or high cytotoxicity of the test substance may lead to false positive results, thus
The results cannot reflect the actual situation of gene mutations in the body.
This test can be used to screen for mammalian mutagens and carcinogens. Positive results in this test are usually seen in carcinogens, but this test
The relevance of the results to carcinogenicity is limited and depends on the mechanism of action of the chemical. The relevance depends on the type of chemical.
Carcinogens that act through non-genotoxic mechanisms or whose carcinogenic mechanisms are not readily detectable in these cells cannot be detected in this assay.
A positive result was obtained.
Chemicals In vitro mammalian cells
Gene mutation test methods
1 Scope
This document specifies the basic principles, test methods, test data and reports for in vitro mammalian cell gene mutation tests on chemicals.
This document applies to the detection of chemical mutations in mammalian cells in vitro.
2 Normative references
This document has no normative references.
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
mutation
A heritable change in the DNA base pair sequence of a gene or in the structure of a chromosome.
3.2
A substance that can cause the substitution of one or more base pairs in DNA.
3.3
After treatment with the test substance, the genetic changes are fixed in the genome and the original gene products (such as enzymes or proteins) are fully consumed until the expression of
The time required for the type feature to be detected.
3.4
mutation frequency mutantfrequency
The proportion of mutant cells detected by selective medium (such as medium containing 6-thioguanine).
3.5
Cloning efficiency
The percentage of cells that can proliferate and form countable colonies relative to the total number of cells seeded.
NOTE. Cells are seeded at a low density, i.e., cells are dispersed and not touching each other.
3.6
Genotoxicity
All types of damage to DNA or chromosomes, including DNA damage, chromosome damage and gene mutation.
NOTE. Not all types of genotoxic effects result in gene mutations or stable chromosomal damage.
3.7
Cytotoxicity
The ratio of the cloning efficiency of the treated group cells to that of the negative control group was lower.
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