Genotoxicolgy
Regulatory Services
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Bacterial Reverse Mutation Test (AMES)DRF/GT/001
This assay assesses Mutagenicity uming Salmonella typhimurium & E.coli with a focus on Mutagenic or Non Mutagenic.
Cell Model
Salmonella typhimurium & E.coliEnd Point
Mutagenic or Non MutagenicRelevance
Mutagenicity
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Enhanced Bacterial Reverse Mutation Test (AMES)DRF/GT/002
This assay assesses mutagenicity (for Nitrosamine Impurity) using Salmonella typhimurium & E.coli with a focus on Mutagenic or Non Mutagenic.
Cell Model
Salmonella typhimurium & E.coliEnd Point
Mutagenic or Non MutagenicRelevance
Mutagenicity (for Nitrosamine Impurity)
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Chromosomal Aberration Test (In-vitro)DRF/GT/003
This assay assesses mutagenicity using Human Peripheral Blood Lymphocyte with a focus on Clastogenic or Non Clastogenic.
Model
Human Peripheral Blood LymphocyteEnd Point
Clastogenic or Non ClastogenicRelevance
Mutagenicity
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Chromosomal Aberration Test (In-vivo)DRF/GT/004
This assay assesses mutagenicity using Bone Marrow Cells of Rodents with a focus on Clastogenic or Non Clastogenic.
Animal Model
Bone Marrow Cells of RodentsEnd Point
Clastogenic or Non ClastogenicRelevance
Mutagenicity
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Micronucleus Test (In-vitro)DRF/GT/005
This assay assesses mutagenicity using Human Peripheral Blood Lymphocyte with a focus on Aenugenicity /Clastogenicity.
Model
Human Peripheral Blood LymphocyteEnd Point
Aenugenicity /ClastogenicityRelevance
Mutagenicity
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Micronucleus Test (In-vivo)DRF/GT/006
This assay assesses mutagenicity using Bone Marrow Cells of Rodents with a focus on Clastogenic or Non Clastogenic.
Animal Model
Bone Marrow Cells of RodentsEnd Point
Clastogenic or Non ClastogenicRelevance
Mutagenicity
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Cell Gene Mutation Test DRF/GT/007
This assay assesses mutagenicity using Chinese Hamster Ovary Cell Line (V79) with a focus on Mutagenic or Non Mutagenic.
Animal Model
Chinese Hamster Ovary Cell Line (V79)End Point
Mutagenic or Non MutagenicRelevance
Mutagenicity
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Fluctuation Bacterial Reverse Mutation Test (AMES)DRF/GT/008
This assay assesses mutagenicity using Salmonella typhimurium & E.coli with a focus on Mutagenic or Non Mutagenic.
Cell Model
Salmonella typhimurium & E.coliEnd Point
Mutagenic or Non MutagenicRelevance
Mutagenicity