Juvenile toxicity of atropine sulfate eye drops in young rats.

IF 1.6 4区 医学 Q3 OPHTHALMOLOGY
Wenqiang Zhang, Wei Yang, Lu Liu, Jinlong Dai, Linyi Wang, Yuankeng Huang, Xialing Lei, Junli Lin, Fafu Zhang, Jianmin Guo
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Abstract

Objectives: This study was to investigate the effects of atropine sulphate eye drops (ASED)on the development of partial systems in young rats and their toxic reactions following repeated eye-drop administration over a period of 40 days.

Methods: SD rats of 20 days old were randomly assigned to control group, 0.01, 0.02, and 0.04% ASED groups, with 60 females and 25 males per group. ASED was given by eye drops from PND21 onwards and normal saline was given in the control group at 10 μL/eye once a day for 40 days, in both right and left eyes. Rats of ASED groups were instilled with eye drops at the 10 μL/day per eye, from postnatal day 21 (PND21) to PND60 for 40 consecutive days. The clinical observation, body weight, food intake, physical development, physiological development, reproductive development, ophthalmic examination, intraocular pressure, and axial length of the rats were examined during the study period.

Results: ASED at concentrations of 0.01, 0.02, 0.04%, dose levels of 0.002, 0.004, 0.008 mg/day per rat, had no toxicological effects on the clinical observation, body weight, food intake, physical development, physiological development, reproductive development, ophthalmic examination, intraocular pressure, and axial length in rats.

Conclusion: The no-observed-adverse-effect-level (NOAEL) of ASED in young SD rats equivalent to human over 2 years old was 0.008 mg/day at a concentration of 0.4 mg/mL.

硫酸阿托品滴眼液对幼鼠的毒性。
目的:本研究旨在探讨硫酸阿托品滴眼液(ASED)对幼龄大鼠部分系统发育的影响及其在40天内反复滴眼液后的毒性反应。方法:将20日龄SD大鼠随机分为对照组、0.01%、0.02和0.04% ase组,每组雌性60只,雄性25只。对照组小鼠自PND21起滴眼给药,对照组小鼠左右眼滴眼生理盐水10 μL/眼,每天1次,连用40 d。ase组大鼠从出生后第21天开始(PND21)至PND60,连续40天滴注10 μL/d /眼滴眼液。观察研究期间大鼠的临床观察、体重、摄食量、体格发育、生理发育、生殖发育、眼科检查、眼压、轴长等指标。结果:在浓度为0.01、0.02、0.04%,剂量水平为0.002、0.004、0.008 mg/d /只大鼠的情况下,对大鼠临床观察、体重、摄食量、体格发育、生理发育、生殖发育、眼科检查、眼压、轴长均无毒理学影响。结论:在0.4 mg/mL的浓度下,ASED在2岁以上幼龄SD大鼠体内的未观察到不良反应水平(NOAEL)为0.008 mg/d。
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来源期刊
CiteScore
3.30
自引率
6.20%
发文量
40
审稿时长
1 months
期刊介绍: Cutaneous and Ocular Toxicology is an international, peer-reviewed journal that covers all types of harm to cutaneous and ocular systems. Areas of particular interest include pharmaceutical and medical products; consumer, personal care, and household products; and issues in environmental and occupational exposures. In addition to original research papers, reviews and short communications are invited, as well as concise, relevant, and critical reviews of topics of contemporary significance.
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