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Magnesium stearate given perorally to rats. A short term study
Toxicology
|January 1, 1980
Summary
High doses of magnesium stearate (20%) in rat diets led to reduced weight gain and urolithiasis. The no-effect level for magnesium stearate in animal diets was determined to be 5%.
Area of Science:
- Toxicology
- Animal Nutrition
Background:
- Magnesium stearate is a common excipient in pharmaceuticals and food products.
- Understanding its toxicological profile is crucial for safety assessments.
Purpose of the Study:
- To evaluate the effects of dietary magnesium stearate on rat health.
- To determine the no-observed-adverse-effect level (NOAEL) of magnesium stearate.
Main Methods:
- Rats (20 males, 20 females) were fed diets containing 0, 5, 10, or 20% magnesium stearate for 3 months.
- Body weight, organ weights, and pathological changes were assessed.
Main Results:
- Reduced weight gain and urolithiasis observed in rats fed 20% magnesium stearate.
- Liver changes, including reduced relative weight and increased iron, occurred at 10% and 20% levels.
- Nephrocalcinosis was reduced in females at the 20% level.
Conclusions:
- The no-effect level for magnesium stearate in the diet is estimated at 5% (2500 mg/kg body weight/day).
- High dietary concentrations of magnesium stearate can induce adverse effects in rats.