In Vitro Chromosome Aberration Test

According to OECD Guidelines for Testing of Chemicals, Test No. 473, the in vitro chromosomal aberration test is used to evaluate the structural abnormalities of chromosome or chromatid, which involve intra-changes, inter-changes, deletions, breaks, fragments and chromosomal disintegration in metaphase stage of cell division.

Fig. 1 Human lymphocyte in metaphase showing a chromosome break with fragment. (Registre, M. 2016)

STEMart provides in vitro chromosomal aberration test to assess the capacity of a medical device to induce structural chromosomal aberration of mammalian cells. This assay is available under either GLP (Good Laboratory Practice) or Non-GLP conditions.

Standard

OECD 473

Test Cell

• Chinese Hamster Ovary (CHO) cells
• Human peripheral blood lymphocytes (HPBL)

Test Method

Cells are incubated with addition of at least three concentrations with duplicates of the medical device extract for 4 hours in the presence and absence of metabolic activation (S9) and for 21 hours (CHO cells) or 24 h (human lymphocytes) in the absence of S9.

Cells are then treated with a metaphase-arresting chemical, such as Colcemid or colchicine, and harvested.

Chromosomal spread slides are then prepared and stained. The presence of chromosomal aberrations in metaphase cells is analyzed under microscopy to evaluate the clastogenic potential of test sample. Gaps are recorded separately.

Negative vehicle control and positive controls are included in each study.

Criteria

An increase in the number of polyploid cells may indicate that the test sample is possible to interfere with the mitotic processes and to induce numerical chromosomal aberrations. An increase in the number of cells with endoreduplicated chromosomes may indicate that the test sample is possible to inhibit cell cycle progression.

A test sample is considered mutagenic if a concentration-related increase or a reproducible increase in the number of cells with chromosomal aberrations at a single test concentration.

Final Report

The final report including information on the methodology, raw data, analysis, and interpretation of the results will be provided for customer.

If you have additional questions about in vitro chromosomal aberration test, or would like to find out more about our services, please feel free to contact us.

References

• US Food and Drug Administration. "Red Book 2000, Toxicological Principles for the Safety of Food Ingredients: IV. C. 1. c. In Vitro Mammalian Chromosomal Aberration Test." (2003).
• OECD. "OECD Guideline for the testing of chemicals, Section 4 Health effects, Test No. 473: In vitro mammalian chromosomal aberration test." (1997): 10.
• Registre, M., et al. "The In Vitro Chromosome Aberration Test." Genetic Toxicology Testing. Academic Press 207-267 (2016).