RESUMO
Due to its calcium-rich and diverse multimineral profile, Aquamin (derived from the red seaweed Lithothamnion sp.) is used globally as a dietary food supplement. Published reports on the genetic and prenatal developmental toxicity of Lithothamnion sp. do not exist. In accordance with the standardized protocols set by the Ministry of Health of the People's Republic of China (GB-15193), the following studies were performed: the Ames test, the mammalian erythrocyte micronucleus test, the mammalian spermatocyte chromosome test, and prenatal developmental toxicity testing. The results showed that Lithothamnion sp. did not induce a significant increase in the following: revertant colony numbers for Salmonella typhimurium strains TA 97, 98, 100, 102 and 1535; frequency of micronucleated polychromatic erythrocytes (MNPCE); spermatocyte chromosomal aberration rate. In the prenatal developmental toxicity study, no mortality, no abnormal changes in behavior and activities, and the absence of toxic symptoms and abnormalities in macroscopic autopsy were observed in each dam/all pups. Compared to the negative control group, Lithothamnion sp. at all tested doses had no effects on body weight gain, number of corpora lutea and implantations, fetal body weight and length, external, visceral and skeletal malformations. In conclusion, Lithothamnion sp. did not cause genetic toxicity. Furthermore, the prenatal developmental toxicity no observed adverse effect level (NOAEL) was determined to be greater than 2000 mg/kg.bw.