OECD 488 Transgenic Rodent Mutation Assay Using Big Blue® Rat for University of Sheffield
Awarded 13 May 2022
About
The University of Sheffield awarded a contract to Gentronix Limited for the conduct of an OECD 488 transgenic rodent mutation assay (TGRA) using the Big Blue® rat with cII mutant selection.
The study, valued at AUD 366,300, involved breeding a target cohort of 46 Big Blue male rats, transferring and validating an HPLC analytical method for dose formulation analysis, performing a 7-day dose-range finding study, and conducting the main TGRA study with daily oral gavage for 28 days.
The main study included vehicle, three dose groups, and a concurrent positive control, with necropsy on day 31 and analysis of liver and duodenum from five animals per dose group.
An integrated Pig-A in vivo mutation analysis was also performed.
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