Genotoxicity
Genotoxicity uses cell cultures, usually mammalian to determine gene mutations, change in chromosome structure and number, and other gene toxicities caused by medical devices, material or their extracts. This is described in ISO 10993-3.
Optional Tests for Genotoxicity
Mouse Lymphoma ISO 10993
Ames mutagenicity, mouse micronucleus ISO 10993
Chromosomal Aberration, two extracts (solid sample/device) OECD 473, ISO 10993-3, ICH S2A, ICH S2B, OECD 471
The purpose of this test is to screen medical devices and materials to determine if they cause structural chromosome aberrations in Chinese Hamster Ovary (CHO) cells. This procedure allows for exposure with and without an exogenous source of metabolic a ctivation. This procedure is designed to comply with the OECD and ISO guidelines as one of the three levels of in vitro tests for genotoxicity. There is evidence to support that chromosome mutations and related events that cause alteration in oncogenes and tumour suppressor genes of somatic cells are involved in cancer induction in humans and experimental animals.
Chromosomal Aberration, one extract (solid sample/device) OECD 473, ISO 10993-3, ICH S2A, ICH S2B, OECD 471
The purpose of this test is to screen medical devices and materials to determine if they cause structural chromosome aberrations in Chinese Hamster Ovary (CHO) cells. This procedure allows for exposure with and without an exogenous source of metabolic a ctivation. This procedure is designed to comply with the OECD and ISO guidelines as one of the three levels of in vitro tests for genotoxicity. There is evidence to support that chromosome mutations and related events that cause alteration in oncogenes and tumour suppressor genes of somatic cells are involved in cancer induction in humans and experimental animals.
AMES mutagenicity test, base oils ASTM E1687-98, ISO 10993-3, ICH S2A, ICH S2B, OECD 471
The Ames test employs several strains of Salmonella typhimurium which have been selected based on their sensitivity to mutation. The test substance (liquid) or an extract of the test substance and the test organism are mixed together in a soft agar solution. Reverse mutation can then be observed.
AMES mutagenicity test, soluble chemical ISO 10993-3, ICH S2A, ICH S2B, OECD 471
The Ames test employs several strains of Salmonella typhimurium which have been selected based on their sensitivity to mutation. The test substance (liquid) or an extract of the test substance and the test organism are mixed together in a soft agar solution. Reverse mutation can then be observed.
AMES mutagenicity test, soluble chemical ISO 10993-3, ICH S2A, ICH S2B, OECD 471
The Ames test employs several strains of Salmonella typhimurium which have been selected based on their sensitivity to mutation. The test substance (liquid) or an extract of the test substance and the test organism are mixed together in a soft agar solution. Reverse mutation can then be observed.
AMES mutagenicity for solids ISO 10993-3, ICH S2A, ICH S2B, OECD 471
The Ames test employs several strains of Salmonella typhimurium which have been selected based on their sensitivity to mutation. The test substance (liquid) or an extract of the test substance and the test organism are mixed together in a soft agar solution. Reverse mutation can then be observed.
AMES mutagenicity test, solids ISO 10993-3, ICH S2A, ICH S2B, OECD 471
The Ames test employs several strains of Salmonella typhimurium which have been selected based on their sensitivity to mutation. The test substance (liquid) or an extract of the test substance and the test organism are mixed together in a soft agar solution. Reverse mutation can then be observed.
