Preclinical safety evaluation of sodium l-methylfolate

Area of Science:

• Nutritional Science
• Toxicology

Background:

• Sodium l-methylfolate (L-5-MTHF-Na) is proposed as an alternative folate source to folic acid in human food.
• Folate is essential for numerous physiological functions.

Purpose of the Study:

• To evaluate the safety profile of Sodium l-methylfolate (L-5-MTHF-Na) for use in human food.
• Assess genotoxicity and repeated dose toxicity of L-5-MTHF-Na.

Main Methods:

• Genotoxicity testing included bacterial reverse mutation assay, in vitro chromosome aberration test, and in vitro micronucleus test.
• Repeated dose toxicity studies involved 14-day and 90-day oral gavage administration in rats up to 1000 mg/kg bw/day.

Main Results:

• L-5-MTHF-Na demonstrated no mutagenic or cytogenetic effects.
• No adverse treatment-related effects were observed in rats across all endpoints in the repeated dose studies.
• Adaptive changes in creatine kinase were noted but considered non-adverse.

Conclusions:

• Sodium l-methylfolate (L-5-MTHF-Na) exhibits a safe profile for dietary folate supplementation.
• Findings are consistent with previous studies on calcium l-methylfolate (L-5-MTHF-Ca).
• L-5-MTHF-Na is suitable for nutritional purposes as a folate source.