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Long-term Behavioral and Reproductive Consequences of Embryonic Exposure to Low-dose Toxicants
Published on: March 6, 2018
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Developmental toxicity study of CBLB502 in Wistar rats
1Cleveland BioLabs, Inc., Buffalo, NY 14203, United States.
Reproductive Toxicology (Elmsford, N.Y.)
|March 8, 2014
Summary
CBLB502, a Toll-like receptor 5 agonist, showed no developmental toxicity in rats. Maternal toxicity was observed at all doses, but no fetal abnormalities were detected.
Area of Science:
- Toxicology
- Immunology
- Developmental Biology
Background:
- CBLB502 is a microbial protein derivative that targets Toll-like receptor 5.
- It has demonstrated anti-inflammatory effects against acute stresses like radiation in preclinical models.
Purpose of the Study:
- To evaluate the potential developmental toxicity of CBLB502 in a rat model.
- To establish the No Observed Adverse Effect Level (NOAEL) for developmental toxicity.
Main Methods:
- Time-mated female Wistar rats received CBLB502 (0, 30, 100, or 300 μg/kg/day) subcutaneously from Gestation Day 6 to 17.
- Toxicokinetic, immunogenicity, and uterine evaluations were performed.
- Maternal body weight, weight changes, and food consumption were monitored.
Main Results:
- Maternal toxicity, including decreased body weight and food consumption, was observed across all dose groups.
- Adjusted body weight and weight changes indicated toxicity at the highest dose (300 μg/kg/day).
- No external, visceral, or skeletal abnormalities were found in the fetuses.
Conclusions:
- The No Observed Adverse Effect Level (NOAEL) for developmental toxicity was determined to be ≥300 μg/kg/day.
- CBLB502 did not induce developmental toxicity in rats, despite causing maternal toxicity at tested doses.
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