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ADVERSE EFFECTS / SAFETY DATA

ADVERSE EFFECTS / SAFETY DATA

Preclinical Toxicology

The toxicity of Pycnogenol is very low. The acute toxicity is low after oral administration in mice, rats, and guinea pigs.122 The most representative median lethal dose (LD50) value, following the current Organisation for Economic Co-operation and Development (OECD) guidelines (OECD 423123), is > 5.0 g/kg body weight in rats.122

In chronic toxicity tests (OECD 408124), oral application of up to 1000 mg/kg/day in rats did not produce abnormal clinical or behavioral signs, nor any change in body weight, hematology, clinical biochemistry, or food/water consumption. Furthermore, no pathomorphological changes were found.122

The level of mutagenicity of Pycnogenol was assessed with the OECD 471125 bacterial reverse mutation test (Ames test), the micronucleus assay in mouse bone marrow cells in vivo, and the chromosome aberration assay in human lymphocytes in vitro.122 The results all converge to suggest that Pycnogenol is nonmutagenic.122