Safety evaluation of calcium L-methylfolate

Area of Science:

• Nutritional Biochemistry
• Toxicology
• Food Science

Background:

• Calcium L-methylfolate (L-5-MTHF-Ca) serves as a folate source and an alternative to folic acid in food and supplements.
• Evaluating the safety of L-5-MTHF-Ca is crucial for its incorporation into human food and dietary supplements.

Purpose of the Study:

• To assess the safety profile of Calcium L-methylfolate (L-5-MTHF-Ca).
• To evaluate genotoxicity, subchronic toxicity, and prenatal developmental toxicity of L-5-MTHF-Ca.

Main Methods:

• Conducted in vitro genotoxicity assays (mutagenicity, chromosomal aberrations).
• Performed in vivo genotoxicity tests (micronucleus test, DNA damage assay).
• Executed a 13-week oral gavage subchronic toxicity study in rats, including developmental toxicity assessment.

Main Results:

• L-5-MTHF-Ca demonstrated no mutagenic or clastogenic effects in vitro.
• In vivo studies confirmed L-5-MTHF-Ca was not genotoxic, teratogenic, or embryotoxic.
• The no observed adverse effect level (NOAEL) was determined to be 400 mg/kg bw/day in the subchronic study.

Conclusions:

• The safety of L-5-MTHF-Ca as a food ingredient is supported by comprehensive in vitro and in vivo toxicological data.
• L-5-MTHF-Ca is safe for use in human food and food supplements.
• No adverse effects were observed at the highest tested dose (400 mg/kg bw/day).