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Juvenile toxicity of atropine sulfate eye drops in young rats
Wenqiang Zhang1, Wei Yang1,2,3, Lu Liu1
1Guangdong Provincial Center for Ophthalmic Drug Creation and Evaluation Engineering Technology, Guangzhou Bay Area Institute of Biomedicine, Guangdong Lewwin Pharmaceutical Research Institute Co., Ltd., Guangdong Provincial Key Laboratory of Drug Non-Clinical Evaluation and Research, TCM Non-clinic Evaluation Branch of National Engineering Research Center for Modernization of Traditional Chinese Medicine, Guangdong, China.
Insights
Atropine sulphate eye drops (ASED) showed no toxic effects in young rats over 40 days. The no-observed-adverse-effect-level (NOAEL) was determined for safe usage in pediatric populations.
Area of Science:
- Ophthalmology
- Toxicology
- Pharmacology
Background:
- Pediatric myopia control often involves low-dose atropine eye drops.
- Understanding the safety profile of atropine sulphate eye drops (ASED) in young animals is crucial for human application.
Purpose of the Study:
- To investigate the toxicological effects of repeated atropine sulphate eye drops (ASED) administration in young rats.
- To determine the no-observed-adverse-effect-level (NOAEL) of ASED in a juvenile rodent model.
Main Methods:
- Young Sprague-Dawley rats (20 days old) received daily eye drops of 0.01%, 0.02%, or 0.04% ASED for 40 days.
- Control groups received normal saline.
- Comprehensive assessments included clinical observations, body weight, food intake, physical and physiological development, reproductive parameters, ophthalmic examinations, intraocular pressure, and axial length.
Main Results:
- No toxicological effects were observed across all measured parameters (clinical, developmental, physiological, reproductive, ophthalmic) at the tested ASED concentrations.
- Specific dose levels of 0.002, 0.004, and 0.008 mg/day per rat did not induce adverse reactions.
Conclusions:
- Atropine sulphate eye drops (ASED) demonstrate a favorable safety profile in young rats.
- The no-observed-adverse-effect-level (NOAEL) for ASED in young SD rats, extrapolated to humans over 2 years old, is 0.008 mg/day at a concentration of 0.4 mg/mL.
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.
