Toxicity Testing


You are a toxicologist working at the National Toxicology Program. You are reviewing a new chemical produced
by Ferengi Corp. It is not yet in commerce, and the chemical is called Felicium. Felicium would be released into
the air through smoke-stacks.
Both acute and chronic toxicity tests have been administered in rats. The data is below.
Table: Felicium Chronic Toxicity in Rats Ferengi Corp. estimates they would release enough Felicium to result
in air concentrations up to 10 µg/m3 in the air. This is the amount that would potentially expose receptor
populations living around their factories. Preliminary testing suggests that Felicium is metabolized by Phase I
and II metabolism. Phase I metabolism does result in bioactivation, yet the toxic metabolite is quickly
eliminated following the use of glutathione in Phase II metabolism.
Using this data, and your knowledge of public health toxicology, ADME and toxicity testing, please answer the
following questions.
Would you recommend Felicium be approved for use by Ferengi, Corp? Please explain why or why not.
Assume Felicium is going to be approved. What safety suggestions (if any) would you apply to Felicium to
protect public health?
Frances Kelsey refused to approve thalidomide because she felt the data was insufficient to show absence of
harm. Looking at the Felicium data, is there additional information that you would like to see? Please explain
what data you think is missing, and how this data would help you as a public health toxicologist better
understand risk management for Felicium.
As a public health toxicologist, what modern toxicity tests would you suggest for Felicium? Please describe the
category of test (in silico, in vitro, Chip, etc.) and why you would select it for Felicium.



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