Safety evaluation of CuminUP60® - A novel curcumin complex

Area of Science:

• Pharmacology and Toxicology
• Natural Product Chemistry

Background:

• Curcuma longa L. is a recognized Curcuma species, with curcumin being its primary bioactive compound.
• Curcumin has a long history of use for various purposes.
• CuminUP60® is a novel curcumin complex derived from Curcuma longa L. rhizome extract and Poloxamer 407.

Purpose of the Study:

• To evaluate the safety profile of CuminUP60® through a series of Good Laboratory Practice (GLP) compliant studies.
• To assess the mutagenic potential of CuminUP60® using in vitro and in vivo assays.
• To determine the acute and sub-chronic toxicity of CuminUP60® in Sprague-Dawley rats.

Main Methods:

• In vitro bacterial reverse mutation assay (Ames test).
• In vitro mammalian cell chromosome aberration study.
• In vivo micronucleus test.
• GLP-compliant single oral dose toxicity study (5000 mg/kg).
• GLP-compliant 4-week repeat dose oral toxicity study.

Main Results:

• CuminUP60® was not found to be mutagenic in the bacterial reverse mutation assay, chromosome aberration study, or micronucleus study.
• A single oral dose of 5000 mg/kg CuminUP60® was well tolerated in male and female Sprague-Dawley rats.
• The no observed adverse effect level (NOAEL) for CuminUP60® was determined to be 1000 mg/kg body weight/day in the 4-week repeat dose study.

Conclusions:

• CuminUP60® exhibits a favorable safety profile with no evidence of mutagenicity.
• The compound is well-tolerated following acute and sub-chronic oral administration in rats.
• The established NOAEL supports the safety of CuminUP60® at the tested dosages.