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Subchronic toxicity evaluation of aloesin
Barry Lynch1, Ryan Simon, Ashley Roberts
1Cantox Health Sciences International, An Intertek Company, 2233 Argentia Road, Suite 308, Mississauga, ON, Canada. blynch@cantox.com
Regulatory Toxicology and Pharmacology : RTP
|July 26, 2011
Summary
Aloesin, a compound from Aloe species, is safe for use as a functional food ingredient. This 90-day rat study found no adverse effects, supporting its potential health benefits for pre-diabetic states.
Area of Science:
- Pharmacology and Toxicology
- Nutritional Science
- Natural Product Chemistry
Background:
- Aloesin, an aromatic chromone from Aloe species, demonstrates potential benefits for metabolic syndrome and pre-diabetic states.
- Its utility as a functional food ingredient necessitates comprehensive safety assessments.
Purpose of the Study:
- To evaluate the safety and toxicological profile of aloesin following repeated oral administration in Sprague-Dawley rats.
- To establish the no-observed-adverse-effect level (NOAEL) for aloesin.
Main Methods:
- Rats (10 male/10 female) received daily oral gavage doses of aloesin (250, 500, or 1000 mg/kg body weight) for 90 days.
- Comprehensive safety assessments included monitoring mortality, body weight, feed/water intake, serum biochemistry, hematology, urinalysis, organ weights, and histopathology.
Main Results:
- Aloesin administration was well-tolerated, with no treatment-related mortality or significant changes in body weight, feed, or water consumption.
- Mild, sex-specific, or non-dose-dependent changes in some hematology and serum biochemistry parameters were observed.
- Dose-dependent increases in urinary ketones were attributed to aloesin's chemical structure, not systemic toxicity.
Conclusions:
- Aloesin demonstrated a favorable safety profile in rats up to 1000 mg/kg body weight/day.
- The no-observed-adverse-effect level (NOAEL) was determined to be 1000 mg/kg body weight/day.
- Results support the potential use of aloesin as a functional food ingredient for metabolic health.
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