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Safety evaluation of calcium L-methylfolate
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-...
Autores principales: | , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Elsevier
2019
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6816227/ https://www.ncbi.nlm.nih.gov/pubmed/31673504 http://dx.doi.org/10.1016/j.toxrep.2019.09.012 |
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author | Niederberger, K.E. Dahms, I. Broschard, T.H. Boehni, R. Moser, R. |
author_facet | Niederberger, K.E. Dahms, I. Broschard, T.H. Boehni, R. Moser, R. |
author_sort | Niederberger, K.E. |
collection | PubMed |
description | 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. |
format | Online Article Text |
id | pubmed-6816227 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2019 |
publisher | Elsevier |
record_format | MEDLINE/PubMed |
spelling | pubmed-68162272019-10-31 Safety evaluation of calcium L-methylfolate Niederberger, K.E. Dahms, I. Broschard, T.H. Boehni, R. Moser, R. Toxicol Rep Article 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. Elsevier 2019-09-26 /pmc/articles/PMC6816227/ /pubmed/31673504 http://dx.doi.org/10.1016/j.toxrep.2019.09.012 Text en © 2019 The Authors http://creativecommons.org/licenses/by/4.0/ This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). |
spellingShingle | Article Niederberger, K.E. Dahms, I. Broschard, T.H. Boehni, R. Moser, R. Safety evaluation of calcium L-methylfolate |
title | Safety evaluation of calcium L-methylfolate |
title_full | Safety evaluation of calcium L-methylfolate |
title_fullStr | Safety evaluation of calcium L-methylfolate |
title_full_unstemmed | Safety evaluation of calcium L-methylfolate |
title_short | Safety evaluation of calcium L-methylfolate |
title_sort | safety evaluation of calcium l-methylfolate |
topic | Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6816227/ https://www.ncbi.nlm.nih.gov/pubmed/31673504 http://dx.doi.org/10.1016/j.toxrep.2019.09.012 |
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