Acute Single-Dose

The following are standard sets of protocols for a number of acute single-dose toxicity studies that we perform. Other routes of administration and study designs are available upon request.

Acute Limit Test (Rodent)

• One group of 5 male and 5 female rats (or mice)
• Single administration of test substance by gavage or IP injection (other routes available)
• Animals are weighed weekly and observed for clinical signs of toxicity and death for 2 weeks after treatment.
• Necropsies are performed on all animals that die and on all survivors at the end of the 2-week study.
• No tissues are preserved; necropsy findings are recorded.

Acute Toxicity Study (Rats or Mice)

• Groups of 5 males and 5 females are treated once with test substance at 3 dose levels by gavage or IP injection (other routes available); a vehicle control group is included (40 animals total).
• Animals are weighed weekly and observed for clinical signs of toxicity and death for 2 weeks after treatment.
• Necropsies are performed on all animals that die and on all survivors at the end of the 2-week study. No tissues are preserved; necropsy findings are recorded.

Local Lymph Node Assay in Mouse

• Groups of 5 female CBA/CA mice are administered the test article at 4 dose levels on the dorsum of each ear for 3 consecutive days; vehicle and positive control groups are included (30 animals).
• On Day 6, mice are injected with 3H-thymidine and euthanized 5 hr later; lymph nodes draining the ears are removed and analyzed for incorporation of 3H-thymidine into proliferating T cells that entered the lymph nodes in response to the test article.
• The degree of 3H-thymidine incorporation is a measure of the ability of the test article to elicit an immune response.