Biologically-derived toxins are products of plants, animals, microorganisms (including, but not limited to, bacteria, viruses, fungi, or protozoa), that can cause adverse effects when inhaled, ingested, injected, or otherwise absorbed into the body.
IBC review is required for the use of unfractionated mixtures and purified preparations of biological toxins having:
- High acute toxicity (i.e., a mammalian LD50 of less than or equivalent to 100 micrograms/kg body weight)
- Significant potential for serious subacute or chronic toxicity (e.g., carcinogenicity).
If either of these conditions is met but a mammalian LD50 is not known, please submit an application. If in doubt, please submit an application.
In the eProtocol application:
Fill out the Biological Toxins Section.
A toxin generated in your lab through molecular recombinant techniques also requires information in the recombinant/synthetic nucleic acid section.
A toxin generated in your lab from toxin-producing microorganisms (non-recombinant) also requires information in the infectious agent section.