Developmental toxicity study of CBLB502 in Wistar rats

•We determined the potential developmental toxicity of CBLB502.•Significantly decreased gestation body, body weight changes and food consumption were observed in all dose groups.•No external, visceral and skeletal malformations were observed.•Based on the results of this study, the NOAEL for develop...

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Veröffentlicht in:Reproductive toxicology (Elmsford, N.Y.) N.Y.), 2014-07, Vol.46, p.12-19
Hauptverfasser: Chow, C. Paul, Faqi, Ali S.
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Sprache:eng
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Zusammenfassung:•We determined the potential developmental toxicity of CBLB502.•Significantly decreased gestation body, body weight changes and food consumption were observed in all dose groups.•No external, visceral and skeletal malformations were observed.•Based on the results of this study, the NOAEL for developmental toxicity was estimated to be ≥300μg/kg/day. CBLB502 is a derivative of a microbial protein that binds to Toll-like receptor 5. It is demonstrated to reduce inflammatory response from acute stresses, such as radiation in animal models. We determined the potential developmental toxicity of CBLB502 in rats. Four groups of 25 time-mated female Wistar rats/group received subcutaneously 0, 30, 100, or 300μg/kg/day of CBLB502 from Gestation Days (GD) 6 to 17 at a dose volume of 1.0mL/kg. Toxicokinetic evaluation was performed on GD 6 and 17. On GD 20 C-section was performed for uterine evaluation and blood samples collected from each dam for immunogenicity assay. Significant decrease in gestation body weight, weight changes and food consumption indicative of maternal toxicity were observed in all dose groups. Also adjusted body weight and weight changes were seen at 300μg/kg/day. No external, visceral and skeletal abnormalities were observed. The NOAEL for developmental toxicity was estimated to be ≥300μg/kg/day.
ISSN:0890-6238
1873-1708
DOI:10.1016/j.reprotox.2014.02.007