Biological toxins or biotoxins are by-products of microorganisms, plants and animals that are hazardous substances at very low doses. Biotoxins used in research applications are increasingly being synthesized by modern methods.

Because biotoxins are not self-replicating, their toxic effect (intoxication) is analogous to chemical poisoning rather than to a traditional infection. Exposure to biotoxins can occur by the respiratory, oral and percutaneous routes. Other possible routes are the direct contact of biotoxin with mucosa (e.g., eye, nose) and with intact skin (e.g., T2 myotoxin).

Submission requirements for research activities with biotoxins at NC State University are dependent on the type of work and if the materials were commercially synthesized. Review the examples below to determine the appropriate submission requirements.

IBC approval:

  • Culturing microorganisms for isolating, purifying, or concentrating the biotoxin.
  • Cloning toxic proteins as follows:
    • Cloning Proteins with an expected LD50 for humans of 1 to 100 ug/kg (BSL-1 recommended)
    • Cloning Proteins with an expected LD50 for humans of >100 ng/kg and <1 ug/kg (BSL-2 to 3 recommended)
    • Cloning Proteins with an expected LD50 for humans of 100 ng/kg or less is prohibited unless granted a specific NIH OBA approval
  • Any work with biotoxins on the Federal Select Agents/Toxins list

Safety Plan:

  • Work in the research laboratory with biotoxins that were commercially synthesized–see the NCSU Chemical Hygiene Plan on Acutely Toxic Agents (p.14).
  • Acutely toxic chemicals with a mammalian lethal dose (LD50) ≤ 100 µg/kg body weight also require completion of a Hazard Review with EHS.

Research Materials Hazardous Classification form

  • Administering to animals biotoxins that were commercially acquired/synthesized.

SOP Examples