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. 2024 Mar 13;22(3):e8656. doi: 10.2903/j.efsa.2024.8656

TABLE 5.

List of toxicological studies with the NF.

Reference Type of study Test system Max dose
Harke (2020), unpublished

Bacterial reverse mutation test

OECD TG 471 (OECD, 2020), GLP

S. Typhimurium

TA98, TA100, TA102, TA1535 and TA1537

Up to 5000 μg/plate (absence and presence of S9 mix)
Kadam (2022), unpublished

In vitro micronucleus test

OECD TG 487 (OECD, 2016a) not in compliance with GLP

CHO‐k1 cells 2000 μg NF/mL
Kadam (2023), unpublished

In vitro micronucleus test

OECD TG 487 (OECD, 2023), GLP

CHO‐k1 cells 2000 μg NF/mL
Kumar (2020), unpublished

In vivo mammalian erythrocyte micronucleus test

OECD TG 474 (OECD, 2016b), GLP

Swiss Albino Mice 2000 mg NF/kg bw per day (oral gavage)
Saravanan (2020), unpublished

90‐day subchronic toxicity study

OECD TG 408 (OECD, 2018) not in compliance with GLP

Sprague Dawley rats 2000 mg NF/kg bw per day
Zhao et al. (no date), unpublished Gastrointestinal tolerability Sprague Dawley, adult male rats 150 mg a /kg bw per day

Abbreviations: CHO, Chinese hamster ovary; GLP, Good Laboratory Practice; NF, novel food; OECD TG, Organisation for Economic Co‐operation and Development for testing of chemicals.

a

Elemental magnesium from Mg l‐threonate (corresponding to ~ 1800 mg/kg bw per day).