Safety and toxicity testing requirements for assessing the safety of food ingredients have evolved over the past years as knowledge in the field of toxicology has expanded. While short-term or acute studies were considered adequate even for major food ingredients several decades ago, today's recommendations generally include comprehensive, long-term toxicity studies.
In making the decisions about such studies, we take into account what is already known about the properties of the compound, its intended conditions of use, and current standards for testing.
Hence in the case of MenaquinGold®, we performed the following safety and toxicity studies:
'Evaluation of MRC- "Coded MK-7" for safety profile and for different pharmacological activities' IA: Safety profile- Acute Toxicity Studies.
Conclusion: It is concluded that the test drug is without any toxic potential even at the dose of 20 mg/kg of 4000 ppm K2-7 in animals equivalent to 896 μg of pure K2-7 (equivalent to 896 mg of 1000 ppm K2-7) for human being.
Chronic Toxicity Studies
'Evaluation of MRC- "Coded MK-7" for safety profile and for different pharmacological activities' IB: Safety profile- Chronic Toxicity Studies.
Conclusion: Based on the analysis of all the available parameters it can be concluded that the test drug "MK-7" has no serious toxicity producing potential especially at the therapeutic dose level.
Genotoxicity study of 'MenaquinGold®aka Menaquin 7' at high dose in rats.
Conclusion: The result of the study indicated that treatment with test drug (MenaquinGold® aka Menaquin 7) at 100 and 1000μg/kgbody weight did not induce any clinical signs of toxicity in rats. There was no significant difference in all the parameters in treatment groups at 100 and 1000 μg/kg body weight at all intervals observed.
Prevention of Genotoxicity
The protection offered by 'MenaquinGold®aka Menaquin 7'against cyclophosphamide induced genotoxicity at therapeutic dose in rats.
Conclusion: The result of the study indicated that treatment with, MenaquinGold® aka Menaquin 7 at 100μg/kg body weight did not induce any clinical signs of toxicity in rats. There was no significant difference in all the parameters, when the treatment groups were compared with the control group at all intervals observed.
LD 50 (Acute oral toxicity) study of 'vitamin K' (MenaquinGold®aka Menaquin 7)
Conclusion: LD50 value of test substance is more than 2000 mg/Kg body weight. This indicates that large oral dose is practically non-toxic for the consumer.
Salmonella typhimurium Reverse mutation assay of "MenaquinGold® aka Menaquin 7"
Conclusion: Under the conditions described for the study, it is concluded that MenaquinGold®aka Menaquin 7 is non-mutagenic in Salmonella typhimurium strains TA 1535, TA97a, TA98, TA100 and TA102.