Table 14.
List of toxicological studies with the NF
| Reference | Type of study | Test system | Dose |
|---|---|---|---|
| Study No. 45339 MMO (Unpublished, 2018a ) | Bacterial reverse mutation test (GLP, OECD TG 471) | S. Typhimurium TA98, TA100, TA102, TA1535 and TA1537 | Up to 5,000 μg/plate (absence and presence of S9 mix) |
| Study No. 45341 MNV (Unpublished, 2018b ) | In vitro micronucleus test (GLP, OECD TG 487) | L5178Y TK+/− mouse lymphoma cells | Up to 200 μg/mL (absence and presence of S9 mix) |
| Study No. FSR‐IPL 201001 (Unpublished, 2021a ) | In vitro micronucleus test (GLP, OECD TG 487) | Human lymphocytes | Up to 1,000 μg/mL (absence and presence of S9 mix) |
| Study No. 45344 TCR (Unpublished, 2018c ) | 90‐day repeated dose oral toxicity study (gavage) (GLP, OECD TG 408, limit test) | Sprague–Dawley rats | 750, 1,250 and 2,500 mg/kg bw per day |
| Study No. 46705 EPR (Unpublished, 2018d ) | Interference assessment of fucoxanthinol for bilirubin dosage in plasma from rats | In vitro method | Rat plasma from 90‐day repeated dose oral toxicity |
| Study No. SR‐EU‐274‐0221 (Unpublished, 2021b ) | Molecular Imaging Study of microgranuloma composition in Rat Liver and Ganglion | Histopathological samples of the 90‐day study | |
| Study No. SR‐EU‐274‐0221 (Unpublished, 2021c ) | Molecular Imaging Study of microgranuloma composition in Rat Liver and Ganglion | Histopathological samples of the 90‐day study | |
| Study number 48722 TSR (Unpublished, 2021d ) | 3‐Week Mechanistic Study by the Oral Route (Gavage) in Rats | Sprague–Dawley male rats | Adrenal function in rats after ACTH challenge following daily oral administration of 2,500 mg/kg bw per day |
bw: body weight; ACTH: adrenocorticotropic hormone.