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Pre-clinical safety assessment of biotechnologically produced lacto-N-tetraose (LNT).
van der Woude, Hester; Pelgrom, Sylvia M J G; Buskens, Carin; Hoffmans, Roy; Krajcs, Nora; Delsing, Dianne J.
Afiliação
  • van der Woude H; Charles River Laboratories, Hambakenwetering 7, 5231 DD, 's-Hertogenbosch, the Netherlands. Electronic address: hester.vanderwoude@crl.com.
  • Pelgrom SMJG; Charles River Laboratories, Hambakenwetering 7, 5231 DD, 's-Hertogenbosch, the Netherlands.
  • Buskens C; Charles River Laboratories, Hambakenwetering 7, 5231 DD, 's-Hertogenbosch, the Netherlands.
  • Hoffmans R; Charles River Laboratories, Hambakenwetering 7, 5231 DD, 's-Hertogenbosch, the Netherlands.
  • Krajcs N; Charles River Laboratories, Veszprém, Szabadságpuszta, 8200, Hungary.
  • Delsing DJ; FrieslandCampina, Stationsplein 4, 3818 LE, Amersfoort, the Netherlands.
Regul Toxicol Pharmacol ; 148: 105580, 2024 Mar.
Article em En | MEDLINE | ID: mdl-38316330
ABSTRACT
Lacto-N-tetraose (LNT) is a human milk oligosaccharide with average concentrations ranging from 0.74 to 1.07 g/L in breastmilk, depending on the lactation stage. In this study, the preclinical safety of LNT produced by the Escherichia coli K-12 E2083 production strain was assessed. LNT was negative in both the bacterial reverse mutation assay and the in vitro micronucleus assay, demonstrating the absence of genotoxic potential for this substance. In the OECD 408 guideline compliant 90-day oral toxicity study rat, LNT did not induce any adverse effects in any treatment group up to and including the highest dose tested, and no LOAEL could be determined. Therefore, the no-observed-adverse effect level (NOAEL) is set at the highest dose level tested, i.e. a dietary level of 5 % (w/w), corresponding to ≥2856 mg/kg bw/day and ≥3253 mg/kg bw/day for males and females, respectively. This might be an underestimation of the NOAEL, caused by the range of dose levels tested. The results obtained in the current study are in good agreement with available data generated using other biotechnologically produced LNT batches and therefore support its safe use as a food ingredient.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Escherichia coli K12 Tipo de estudo: Guideline Limite: Animals / Female / Humans / Male Idioma: En Revista: Regul Toxicol Pharmacol Ano de publicação: 2024 Tipo de documento: Article

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Escherichia coli K12 Tipo de estudo: Guideline Limite: Animals / Female / Humans / Male Idioma: En Revista: Regul Toxicol Pharmacol Ano de publicação: 2024 Tipo de documento: Article