Safety evaluation of calcium L-methylfolate.
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Safety evaluation of calcium L-methylfolate.

Niederberger, K E;Dahms, I;Broschard, T H;Boehni, R;Moser, R;
toxicology reports 2019 Vol. 6 pp. 1018-1030
284
niederberger2019safetytoxicology

Abstract

Calcium L-methylfolate (L-5-MTHF-Ca; CAS Number 151533-22-1) is a source of folate and an alternative to folic acid for use in human food and food supplements. The safety of L-5-MTHF-Ca was evaluated by testing for genotoxicity, subchronic and prenatal developmental toxicity. In assays L-5-MTHF-Ca was not mutagenic and did not induce other chromosomal events. Additionally, L-5-MTHF-Ca was not genotoxic in the micronucleus test nor did it induce DNA damage in rat liver cells. In a subchronic toxicity study, rats administered up to 400 mg/kg bw/day of L-5-MTHF-Ca oral gavage for 13 weeks had no treatment-related mortalities, and no treatment-related effects were identified on behaviour, body weight, food consumption, ophthalmology, haematology, or organ weights. No treatment-related macroscopic or histopathological findings were observed. Calcium and sodium levels increased with increasing dosage, however the slight increases were within historical control ranges and reversible after the recovery period. L-5-MTHF-Ca is neither teratogenic nor embryotoxic. Based on the results of the and studies, the safe use of L-5-MTHF-Ca as an ingredient in foods is supported. The no observed adverse effect level was the highest dose in the subchronic toxicity study, 400 mg/kg bw/day for male and female rats.

Keywords

toxicity developmental toxicity genotoxicity 5-mthf, 5-methyltetrahydrofolate anova, analysis of variance bap, benzo[a]pyrene calcium l-methylfolate efsa, european food safety authority gd, gestation day glp, good laboratory practice gras, generally recognized as safe hplc, high performance liquid chromatography jecfa, joint fao/who expert committee on food additives l-5-mthf-ca l-5-mthf-ca, calcium l-methylfolate mtt, 3-[45-dimethylthiazole-2-yl]-2,5-diphenylbromide nng, net grains/nucleus noael, no observed adverse effect level oecd, organisation for economic co-operation and development tft, 5-trifluorothymidine usp, united states pharmacopeia we-i, williams e medium-incomplete bw, body weight

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DOI:
10.1016/j.toxrep.2019.09.012

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