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Safety
KANEKA Q10™ is CoQ10 with an all-trans configuration. KANEKA Q10™ is identical to naturally occurring CoQ10 found in meat, fish and other food products.
The safety of KANEKA Q10™ is assured in various safety tests including "Safety Assessment of CoQ10 (KANEKA Q10™) in Healthy Subjects" and "52-week oral gavage chronic toxicity study" conducted by one of the world's most trusted testing laboratories (Covance Laboratories Inc.)
  *Safety Assessment of CoQ10 (KANEKA Q10™) in Healthy Subjects:
A Double-blind, Randomized, Placebo-Controlled Trial for 4 weeks.
Material : KANEKA Q10™
Subjects : 88 healthy adult volunteers (55 male and 33 female)
Dose : 0, 300, 600, 900 mg / day
KANEKA Q10™ was well tolerated and safe for healthy adults at intake of up to 900 mg/day.
  *52-week oral gavage chronic toxicity study
Material : KANEKA Q10™ / corn oil
Animals : 494 rats (247 male and 247 female)
Dose : 100, 300, 600 or 1,200 mg / kg / day
KANEKA Q10™ was well tolerated by male and female rats at a dose level of up to 1,200 mg / kg / day.
KANEKA Q10™ has been utilized in a variety of applications around the world. KANEKA Q10™ has demonstrated its superior safety record and uselfulness as a dietary supplement and for cosmetic application.
Toxicity studies Details
Regulatory Toxicology and Pharmacology 44 (2006) 212-218 Healthy Subjects: Oral administration of 900mg/day for 4 weeks
Results: No toxic effect was observed.
Acute toxicity test LD50: 50% lethal dose (oral)
rat ≥ 4,000mg/kg
Chronic toxicity test
J. Agric Food. Chem., 47(9)3756-3763, 1999
Rat: Oral administration of 1,200mg/kg/day for 52 weeks
Results: No toxic effect was observed.
Reproductive and developmental toxicity
Iyakuhin Kenkyu,
3(3) 306-315, 1972
Oral administration of 600mg/kg/day for 7days of the gestation periods of rats (days 9 to 15) and mice (days 7 to 13).
Results: No effect on development of fetuses and neonates was observed.
Mutagenicity Bacterial reverse mutation test (Salmonella typhimurium strains TA100, Ta1535, TA98, TA1537, and Escherichia coli WP2 uvrA)
Results: Negative
Mutagenicity Chromosomal aberration test (Chinese hamster lung (CHL/IU) cells)
Results: Negative
Mutagenicity Micronucleus test (mouse): Oral administration of 2,000mg/kg/day × 2
Results: Negative
Others:
Skin Sensitization Test (Maximization Test in guinea pigs)
Results: Negative
Potential ubiquinone toxicity was assessed in healthy subjects administrated CoQ10 by oral gavage for 4 weeks at 0, 300, 600, 900 mg/day.
Physical
examination
  Body weight, blood pressure, pulse, electrocardiogram, body temperature, medical examination by interview
Hematology
Leucocytes, basophils, eosinophils, lymphocytes, hemoglobin, hematocrit, platelets
Blood
biochemistry
Total protein, albumin A/G, AST (GOT), ALT (GPT), LDH, ALP, γ-GTP, total bilirubin, creatinine, urea nitrogen, ureic acid, CPK, TC, HPL-C, LDL-C, TG, Na, K, Cl, glucose, HbAlc, fructosamine, lactic acid, insulin, glyco-albumin
Urinalysis
pH, protein, glucose, occult blood, bilirubin, urobilinogen
KANEKA Q10™ was well tolerated and safe for healthy adults at intake of up to 900 mg/day
Potential ubiquinone toxicity was assessed in rats administrated CoQ10 by oral gavage for 1 year at 100, 300, 600 and 1,200 mg/kg/day
Material
  KANEKA Q10™ / Corn oil
Animal
494 rats (247 male and 247 female)
Dose
100, 300, 600, 1,200 mg/kg/day
Administration
Once a day, forced oral administration
Test Items
Morbidity / Body weight / Food consumption
Hematology and blood biochemistry
Urine chemistry / Ophthalmic examinations
Histopathology etc.
Toxicokinetic analysis
(blood CoQ10 concentration)
KANEKA Q10™ was well tolerated by male and female rats at a dose level of up to 1,200mg/kg/day
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