Table 3.
List of toxicological studies with the NF
Test item | Reference | Type of study | Test system | Dose |
---|---|---|---|---|
NF | National Medicines Institute (2016) | Bacterial reverse mutation test | Salmonella Typhimurium TA97, TA98, TA100 and TA102 | Up to 5,000 μg Se/plate (absence and presence of S9 mix) |
NF | Rahden‐Staroń et al. (2010) | Bacterial reverse mutation test | S. Typhimurium TA97a, TA98, TA100, TA1535 and TA102 | Up to 5% corresponding to 5,000 μg Se/plate (absence and presence of S9 mix) |
NF micelles | National Medicines Institute (2018) | In vitro mammalian cell micronucleus test | Mouse fibroblasts NCTC clone 929, ATCC | 2 mg/mL (absence and presence of S9 mix) |
Selol (unknown % selenium) | Jastrzębski et al. (1995) | Acute toxicity study | Male Wistar rats |
Up to 200 mg/kg bw oral gavage Up to 100 mg/kg bw intraperitoneal Up to 500 mg/kg bw subcutaneous |
Cumulative toxicity study | Male Wistar rats | Up to 154 mg/kg bw oral gavage | ||
NF | Institute of Industrial Organic Chemistry (2017) | 90‐day repeated dose oral toxicity study | Wistar rats | Up to 32 mg/kg bw per day |
bw: body weight; GLP: good laboratory practice; OECD TG: Organisation for Economic Co‐operation and Development – Test guideline.