Developmental toxicity evaluation of trimethylolpropane caprylate caprate in Sprague-Dawley rats

Author(s):  
Charles Azuka ◽  
George P. Daston

2003 ◽  
Vol 24 (4) ◽  
pp. 231-240 ◽  
Author(s):  
Moon-Koo Chung ◽  
Jong-Choon Kim ◽  
Sung-Ho Myung ◽  
Dong-Il Lee


1992 ◽  
Vol 30 (4) ◽  
pp. 269-275 ◽  
Author(s):  
C.L. Gaworski ◽  
T.A. Vollmuth ◽  
R.G. York ◽  
J.D. Heck ◽  
C. Aranyi


2019 ◽  
Vol 304 ◽  
pp. 28-42 ◽  
Author(s):  
Abdulmannan H. Fateh ◽  
Zahurin Mohamed ◽  
Zamri Chik ◽  
Abdulsamad Alsalahi ◽  
Siti Rosmani Md Zin ◽  
...  




2013 ◽  
Vol 32 (5) ◽  
pp. 385-394 ◽  
Author(s):  
Antoinette Y. Odendaal ◽  
Narendra S. Deshmukh ◽  
Tennille K. Marx ◽  
Alexander G. Schauss ◽  
John R. Endres ◽  
...  

This toxicological assessment evaluated the safety of a hydroethanolic extract prepared from Caralluma fimbriata (CFE), a dietary supplement marketed worldwide as an appetite suppressant. Studies included 2 in vitro genotoxicity assays, a repeated dose oral toxicity study, and a developmental study in rats. No evidence of in vitro mutagenicity or clastogenicity surfaced in the in vitro studies at concentrations up to 5000 μg of extract/plate (Ames test) or 5000 μg of extract/mL (chromosomal aberration test). No deaths or treatment-related toxicity were seen in the 6-month chronic oral toxicity study in Sprague-Dawley rats conducted at 3 doses (100, 300, and 1000 mg/kg body weight (bw)/d). The no observed effect level for CFE in this study was considered to be 1000 mg/kg bw/d. A prenatal developmental toxicity study conducted at 3 doses (250, 500, and 1000 mg/kg bw/d) in female Sprague-Dawley rats resulted in no treatment-related external, visceral, or skeletal fetal abnormalities, and no treatment-related maternal or pregnancy alterations were seen at and up to the maximum dose tested. CFE was not associated with any toxicity or adverse events.



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