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Microbial Pesticides

Since 1985, the Microbiology and Molecular Biology Division at IITRI has worked in the field of microbial pesticides, particularly in the development and validation of mammalian toxicity and pathogenicity testing. IITRI has considerable experience in performing acute mammalian toxicity as evidenced by the numerous biopesticide registrations obtained by our Sponsors. Because of our intimate knowledge of U.S. EPA and Canadian (Health Canada and Agricultural Canada) guidelines, our Sponsors are assured that studies conducted at IITRI will meet or surpass all U.S. EPA and Canadian requirements. IITRI also aids our Sponsors in safety assessment of microbials used in bioreactors as currently requested by the OECD (Organization for Economic Cooperation and Development). IITRI is also a member of the Biopesticide Industry Alliance (BPIA).

From 1985 to 1994, IITRI investigated methods for testing toxicity and virulence of microbial pest control agents (MPCAs) under a cooperative agreement with the U.S. Environmental Protection Agency (EPA). As a result of IITRI research, FIFRA Subdivision M guidelines (and now OPPTS guidelines) for testing acute toxicity/pathogenicity of MPCAs were markedly changed.

  • Requirements for inhalation exposure of test animals were replaced with protocols for intranasal or intratracheal challenge.
  • Number of animals required for testing, as well as the interim sacrifice times for determining microbial clearance rates, were based on IITRI results.
  • Protocols for determining acute mammalian toxicity/pathogenicity by pulmonary and oral challenge routes were validated at IITRI.

Our research facilities include a four-room animal biosafety level-2 (ABSL-2) and three-room ABSL-3 animal care facility containing HEPA-filtered animal rooms and separate HEPA-filtered BSL-2/3 research laboratories containing laminar flow biosafety cabinets, automatic agar dispensers for Petri dishes, incubators, tissue homogenizers, balances, and an automatic colony counter. Studies are conducted under Good Laboratory Practice (GLP) guidelines unless otherwise specified by the Sponsor.

OPPTS* and OECD** - Test Guidelines

Oral toxicity870.1100*, 870.3100*, 870.3150*, 401,** 407**, 408**, 409**, 420**
Dermal toxicity870.1200*, 870.3200*, 870.3250 402**, 410**, 411**
Inhalation toxicity870.1300*, 870.3465*, 403**, 412**, 413**
Acute eye irritation870.2400*, 405**
Acute dermal irritation870.2500*, 404**
Skin sensitization870.2600*, 406**, 429**
Immunotoxicity870.7800*, 880.3550*
Reproductive/fertility toxicity870.3800*

OPPTS Series 885 - Microbial Pesticide Test Guidelines

Storage stability885.2400
Acute oral toxicity/pathogenicity885.3050
Acute dermal toxicity/pathogenicity885.3100
Acute pulmonary toxicity/pathogenicity885.3150
Acute injection toxicity/pathogenicity885.3200
Acute toxicity, Tier II885.3550
Subchronic toxicity/pathogenicity885.3600