Zhang et. al 2020- General Toxicity | China
Evaluation of acute and sub-chronic toxicity of lithothamnion sp. in mice and rats
Ying Zhanga, *, Ruotao Tiana , Haili Wub , Xuemin Lia , Shuqin Lia , Linxiu Biana
Institute of Toxicology, Shanxi Provincial Center for Disease Control and Prevention, Taiyuan, 030012, China College of Life Science, Shanxi University, Taiyuan, 030006, China
Background:
Aquamin is widely available as a calcium and multi-mineral supplement and has a long history of both safety and efficacy. However, published data on the toxicological effects of Aquamin are limited. Therefore, this study was designed to examine the acute and sub-chronic toxicity of Aquamin in order to confirm its safety, at high dose rates.
Methods:
For the acute toxicity evaluation in mice, 20 mice were fasted for 4 hours and then administered a single oral dose of Aquamin F at 10 g/kg body weight. The mice were closely monitored for any changes in behavior, signs of toxicity, and mortality at various time intervals for 13 days. Body weights were recorded before treatment and on Day 7 and 14. At the end of the experiment, all mice were sacrificed, and a necropsy (examination of the body after death) was performed.
For the sub-chronic toxicity evaluation in rats, 80 rats up to 6 weeks were randomly assigned to 4 groups. The rats in the treatment groups were provided with pelleted feed containing Aquamin F at different addition rates: 0.625%, 1.25%, and 2.50%. The control group received pelleted feed without Aquamin F. The experiment lasted for 90 days. The chosen dosing levels were intended to exceed average human consumption of Aquamin F by 100-fold to account for variability between species and individuals. Detailed observations of the rats’ gait, posture, behavior, and mortality were performed daily. Ophthalmological examinations were also conducted. Body weights were recorded before grouping, weekly thereafter, and at necropsy. Food consumption was monitored twice a week to calculate food utilization rates and the actual dosage of Aquamin F received by each rat.
Results:
For the acute toxicity evaluation in mice, no adverse effects, and no mortality was observed in mice administered a single dose of 10 g/kg BW of Aquamin F. Body weight increase of the mice over the course of the experiment was within normal range. No pathological lesions of liver, kidneys, spleen or intestinal tract were observed.
For the sub-chronic toxicity evaluation in rats, Aquamin F at all tested doses did not cause adverse effects on skin, fur, eyes, mucous membranes, secretions, excretions and autonomic activity during the 90-day study. No mortality was observed.
Conclusion:
This study confirms that Aquamin F is a non-toxic substance with an LD50 greater than 10 g/kg BW. The no-observed-adverse-effect-level (NOAEL) of Aquamin F in SD rats was 2100 mg/kg BW for male rats and 2690 mg/kg BW for female rats under these experimental conditions of a standard sub-chronic toxicity study.
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