Regulatory Toxicology
VME 6620 Regulatory Toxicology


This is a 3-credit course.


Regulatory toxicology includes the evaluation of substances in prescribed assays, the goal of which is to determine hazards to humans and environmental species. This course will review the basics in the practice of conducting studies using prescribed in vivo and in vitro systems and evaluating the results. Students will learn about how studies are conducted; what data are generated and in what forms; and how to interpret the data. The student will be expected to develop communications skills so that results can be presented in an unbiased way, and students will learn to translate significant results into Hazard Communications phrases and symbols.

In addition, alternative, non-animal methods to generate information that previously relied on experimental animals will be presented. Students will learn about proper animal care, husbandry, and designs of animal facilities. Testing requirements and regulatory jurisdiction will be presented for industrial chemicals, pharmaceuticals, and nanomaterials. Students are expected to read sections in the textbook and regulatory documents freely available on the internet. These documents are the beginnings of reference materials for subsequent work in the regulatory arena.

Course Learning Outcomes

After successful completion of this course, students will be able to:

  1. Use the elements necessary to conduct a Regulatory Toxicology study to write a protocol for a
  2. Analyze and interpret data in a Regulatory context.
  3. Write results in a neutral, unbiased way, and
  4. Translate the results in the appropriate Hazard Communication phrase.
  5. Apply the principles of Good Laboratory Practice regulations to non-regulatory studies.


Please review our recommended course order.


Week Topic
Week 1 Regulatory Agencies, laws, jurisdictions, and acronyms.
Week 2 Good Laboratory Practice standards. Laboratory animals and their care.
Week 3 Elements of a good study design. Testing of pharmaceuticals, biologics, and medical devices
Week 4 Testing of chemicals (industrial and pesticidal) and nanomaterials in the US, Europe, Canada, and Japan. Testing of nanomaterials.
Week 5 Conducting single exposure studies and evaluating data. Conducting Irritation and Sensitization studies and evaluating data.
Week 6 Genetic toxicity testing.
Week 7 Exam I
Week 8 Conducting Repeated-dose studies.
Week 9 Conducting a lifetime study. discussion/assignment Interpretation of in-life and post-life data.
Week 10 Specialty endpoints: neurotoxicity, developmental and reproductive toxicity, endocrine disruption.
Week 11 Reporting the results
Week 12 Exam II
Week 13 Testing of environmental species: environmental fate estimations and impacts.
Week 14 Testing of terrestrial species: earthworms, plants, avian. TSCA 8 (e) notification; EPA pesticide and consumer product labelling, GHS classifications.
Week 15 Exam III

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