Since the day when kojic acid was used, its safety has attracted wide attention from related scholars. Relevant scholars have stated that the pyran in the kojic acid molecule is the same directional compound as benzene, and in theory, is as carcinogenic as benzene. In addition, the hydroxyl group in kojic acid can also accumulate free radicals in the human body, which is also carcinogenic. In particular, Japan, the main producer of kojic acid, which approved kojic acid as food and pharmaceutical additives, was approved in 1988. In 2003, it announced that it would suspend production and import until further studies on the carcinogenicity and genotoxicity of kojic acid were obtained. After non-medicinal and other products containing kojic acid, more and more scholars are researching the safety of kojic acid.
In recent years, many foreign scholars have conducted a large number of studies on the genetic toxicity, carcinogenicity, embryotoxicity, and teratogenic effects of kojic acid, and the mutagenicity of genetic material. The results show that poultry are more sensitive to kojic acid, and mice are more sensitive to kojic acid. The LD50 of kojic acid is in the range of 1,000 to 1,500 mg/kg. The oral kojic acid dose is within the range of 300～1 000 mg/(kg·d). Regardless of whether the various clinical physiological and biochemical indexes of male or female rats are normal, autopsy and microscopic observation have not found any effect, only lymphocytes And white blood cells are slightly reduced. The intraperitoneal route of administration was used for each injection of kojic acid at a dose of 300 mg/kg. After 14 days, the rats developed pathological phenomena of hepatocytotoxicity. However, the results of studies on the effects of kojic acid on the fertility and embryos of rats are uncertain.
Whether kojic acid has a mutagenic effect on the genetic material of organisms, except that kojic acid can induce mutations in the genes of certain strains of Salmonella and Bacillus subtilis, different researchers have reached different conclusions. To find out whether kojic acid has a mutagenic effect on the genetic material of organisms, Gerhard et al. confirmed through a series of tests that all the results of the genotoxicity test of kojic acid in vivo were negative. Numerous research evidence indicates that kojic acid-induced thyroid hyperplasia has nothing to do with genotoxic pathways. Continuous high-dose kojic acid can inhibit iodine in mice and rats
The absorption of the thyroid gland and induce thyroid hyperplasia and adenoma. Adding kojic acid to food may have the risk of inducing thyroid tumors, but the current test is limited to mice and rats, and there is no other animal test evidence. Burdock et al., based on their experiments and the results of other people's studies, believe that continuous high-dose kojic acid can induce thyroid adenomas in mice and rats and extend it to the possibility of inducing human thyroid tumors. There is no experimental basis. At the same time, the concentration of kojic acid in food is extremely low, and it should be safe to use under normal conditions.
As the country that has replaced Japan as the largest producer of kojic acid, great attention has been paid to the safety of kojic acid. The dosage of kojic acid is strictly limited. Now people's practice is to formulate strict corporate standards according to customer needs, which are generally divided into three levels: food grade, cosmetic grade, and pharmaceutical grade. Kojic acid is a low-toxic substance. Long-term high-dose use may affect the growth and development of experimental animals and changes in the structure and function of organs. In vivo, mouse bone marrow cell micronucleus test did not observe obvious genotoxicity of kojic acid, but the in vitro test is of high-quality Concentrations of kojic acid can cause DNA damage for a certain period. Kojic acid cultured CHO-K1 cells for 96 hours showed a significant apoptosis-inducing effect, but almost no induction effect in the early stage of exposure. The effect of using a small amount of kojic acid on the human body has not been further confirmed. Some theoretical speculations cannot produce quite convincing evidence. Investigations show that Kojic acid is added and used in low doses in brand cosmetics such as Lancome, Helena, and Vichy.
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