Genotoxicity and subacute toxicity studies of a new astaxanthin-containing <i>Phaffia rhodozyma</i> extract
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Experimental and clinical studies demonstrate that astaxanthin (AXN), a xanthophyll carotenoid, has protective effects against oxidative damage. Because most of these studies assessed AXN derived from <i>Haematococcus pluvialis</i> that were cultivated at industrial scales, few studies have examined the toxicity of AXN derived from <i>Phaffia rhodozyma</i>. To evaluate the safety of astaxanthin-containing <i>P. rhodozyma</i>extract (AXN-PRE), genotoxicity was assessed in bacterial reverse mutation test and mouse bone marrow micronucleus test, and general toxicity was assessed in 4-week repeated oral toxicity study in rats. AXN-PRE did not induce reverse mutations in the <i>Salmonella typhimurium</i> strains TA98 or TA100 at concentrations of 5,000 µg/plate with or without S9 mix, and no chromosome damage was observed at a dose of 2,000 mg/kg in mouse micronucleus test. In the subacute toxicity study, male and female Sprague–Dawley rats were given AXN-PRE at doses of 0, 500, and 1,000 mg/kg by gavage for 4 weeks. Body weights, urinalysis, hematology, serum biochemistry, organ weights, or histopathological lesions indicated no distinct toxicity. In conclusion, AXN-PRE had no effect in bacterial reverse mutation test and mouse bone marrow micronucleus test. The no-observed-adverse-effect level for AXN-PRE in 4-week repeated oral toxicity study in rats was determined to be greater than 1,000 mg/kg (corresponding to dose of 50 mg/kg AXN) regardless of gender.
- The Journal of Toxicological Sciences
The Journal of Toxicological Sciences 39(3), 373-382, 2014
The Japanese Society of Toxicology