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. 2022 Apr 8;20(4):e07204. doi: 10.2903/j.efsa.2022.7204

Table 9.

List of toxicological studies with the NF

Reference Type of study Test system Dose
Study No. 190013 (Unpublished, 2019a)

Bacterial reverse mutation assay (GLP, OECD TG 471)

 Salmonella Typhimurium TA98, TA100, TA1535 and TA1537. Escherichia coli WP2 uvrA

  • 31.6–5,000 µg/plate

  • Plate incorporation and pre‐incubation tests with/without metabolic activation via S9 mix

Study No. 190014

(Unpublished, 2019b)

In vitro mammalian micronucleus test in human lymphocytes

(GLP, OECD TG 487)

 Human peripheral blood lymphocytes

  • 4 h: With (500–2,000 μg/mL) and without (1000–2,000 μg/mL) metabolic activation (S9 mix)

  • 44 h: Without metabolic activation (1,000–2,000 μg/mL)

Study No. 190015

(Unpublished, 2019c)

 14‐day repeated dose oral range‐finding toxicity study Healthy Wistar rats, Crl:WI(Han) (Full Barrier) 100, 300, 1,000 mg/kg bw per day

Study No. 190016

(Unpublished, 2020)

 90‐day repeated dose oral toxicity study (GLP, OECD TG 408 – 2018) Healthy Wistar rats, Crl:WI(Han) (Full Barrier) 100, 300, 1,000 mg/kg bw per day