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Calcium-Scoring CT ScanA calcium-scoring CT scan, also known as coronary artery calcium (CAC) scan, detects calcium deposits in the coronary arteries. This test assesses the risk of coronary artery disease (CAD), which can lead to cardiovascular events such as angina, heart failure, and sudden cardiac arrest.A calcium-scoring CT scan is generally recommended for individuals at intermediate risk of CAD without symptoms. It includes:Men aged 40-75 and women aged 50-75: Especially those with a...
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Safety evaluation of calcium L-methylfolate.

K E Niederberger1, I Dahms2, T H Broschard3

  • 1Leveret GmbH, Aberenrain 30, 6340, Baar, Switzerland.

Toxicology Reports
|November 2, 2019
PubMed
Summary

Calcium L-methylfolate (L-5-MTHF-Ca) is a safe folate source for food and supplements. Studies show it is not genotoxic, teratogenic, or embryotoxic, supporting its use in human food products.

Keywords:
5-MTHF, 5-methyltetrahydrofolateANOVA, analysis of varianceBaP, benzo[a]pyreneCalcium L-methylfolateDevelopmental toxicityEFSA, European Food Safety AuthorityGD, gestation dayGLP, Good Laboratory PracticeGRAS, generally recognized as safeGenotoxicityHPLC, High Performance Liquid ChromatographyJECFA, Joint FAO/WHO Expert Committee on Food AdditivesL-5-MTHF-CaL-5-MTHF-Ca, calcium L-methylfolateMTT, 3-[45-dimethylthiazole-2-yl]-2,5-diphenylbromideNNG, net grains/nucleusNOAEL, No Observed Adverse Effect LevelOECD, Organisation for Economic Co-operation and DevelopmentTFT, 5-trifluorothymidineToxicityUSP, United States PharmacopeiaWE-I, Williams E medium-Incompletebw, body weight

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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).