Safety evaluation of calcium L-methylfolate
| Autor: | R. Moser, R. Boehni, K.E. Niederberger, I. Dahms, T.H. Broschard |
|---|---|
| Rok vydání: | 2019 |
| Předmět: |
GRAS
generally recognized as safe Health Toxicology and Mutagenesis OECD Organisation for Economic Co-operation and Development Developmental toxicity 010501 environmental sciences Pharmacology Toxicology medicine.disease_cause 01 natural sciences WE-I Williams E medium-Incomplete 0302 clinical medicine L-5-MTHF-Ca Medicine ANOVA analysis of variance In vitro toxicology GLP Good Laboratory Practice JECFA Joint FAO/WHO Expert Committee on Food Additives embryonic structures Micronucleus test Toxicity BaP benzo[a]pyrene NOAEL No Observed Adverse Effect Level GD gestation day NNG net grains/nucleus No-observed-adverse-effect level L-5-MTHF-Ca calcium L-methylfolate chemistry.chemical_element EFSA European Food Safety Authority Calcium bw body weight Article USP United States Pharmacopeia MTT 3-[45-dimethylthiazole-2-yl]-2 5-diphenylbromide 03 medical and health sciences lcsh:RA1190-1270 In vivo TFT 5-trifluorothymidine Calcium L-methylfolate HPLC High Performance Liquid Chromatography lcsh:Toxicology. Poisons 0105 earth and related environmental sciences business.industry chemistry Genotoxicity business 5-MTHF 5-methyltetrahydrofolate 030217 neurology & neurosurgery |
| Zdroj: | Toxicology Reports, Vol 6, Iss, Pp 1018-1030 (2019) Toxicology Reports |
| ISSN: | 2214-7500 |
| Popis: | Highlights • The toxicity of calcium L-methylfolate was studied. • No toxic, mutagenic, teratogenic nor embryogenic effects were observed. • The NOAEL for calcium L-methylfolate was 400 mg/kg bw/day. 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 in vitro 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 in vivo 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 via 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 in vitro and in vivo 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, i.e. 400 mg/kg bw/day for male and female rats. |
| Databáze: | OpenAIRE |
| Externí odkaz: |
|