Zhang et al., 2020 Prenatal Toxicity – China
A study of the genetic and prenatal developmental toxicity potential of lithothamnion sp
Z. Ying , T. Ruotao , W. Haili , L. Shuqin , B. Linxiu , L. Xuemin & L. Qing
Institute of Toxicology, Shanxi Provincial Center for Disease Control and Prevention, Taiyuan, 030012, China College of Life Science, Shanxi University, Taiyuan, 030006, China
Background:
The use of Aquamin in food and dietary supplements, is increasing globally. To ensure safety, the genetic and prenatal toxicity potential of Aquamin must be thoroughly investigated. Limited information on the toxicological potential of Aquamin prompted a study conducted according to standardized protocols in China. The study concluded that the LD50 and NOAEL of Aquamin were 10 g/kg BW and 2 g/kg BW, respectively, far exceeding typical human doses. To evaluate the genetic and prenatal toxicity, the Ames test, mammalian erythrocyte micronucleus test, mammalian spermatocyte chromosome aberration test, and prenatal developmental toxicity study were conducted, following standardized protocols set by the Ministry of Health of China.
Results:
The body weight of pregnant dams is an important indicator of pregnancy progression and embryonic development. In this study, different doses of Aquamin were administered to pregnant rats, and their body weights were compared to a negative control group. No significant differences were found, indicating that Aquamin did not pose any toxicity risks during pregnancy.
Various parameters related to fertility and pregnancy outcomes were also examined. The number of corpora lutea, implantations, alive fetuses, fetal absorption, and dead fetuses were reported. Fertility and pregnancy outcomes in the treated groups were comparable to the control group, and examinations of the fetuses showed no significant differences in body length, weight, or external, visceral, and skeletal characteristics. The occurrence of skeletal aberrations was within normal limits, and fetal weights in the treated groups were similar to those in the control group.
- Conclusion:
- Aquamin is determined to be non-toxic to both dams and fetuses at all tested doses. The prenatal developmental toxicity no observed adverse effect level (NOAEL) was determined to be greater than 2 g/kg body weight.
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