From Safety Evaluation to Influencing Factors Analysis: A Comprehensive Investigation on Ocular Irritation of Baby...

Given the underdevelopment and sensitivity of babies' eyes, frequently used baby bath products have garnered attention for their ocular irritation safety. The selection and application of raw materials are key factors. We tested 39 commercial baby bath products for ocular irritation safety and proposed a novel evaluation method using the "Risk Attention Index" to analyze formulation risk factors. The ocular irritation potential of 39 commonly used raw materials under typical usage conditions was investigated via animal and cell models. Results showed over 20% of commercial products had safety risks. Surfactants like cocamidopropyl betaine (CAPB), sodium laureth sulfate (SLES), and sodium lauroamphoacetate (SLA) had the highest "Risk Attention Index", requiring special attention. Some fragrance components were also potential irritants. Combining SLES with panthenol, maltooligosyl glucoside/hydrogenated starch hydrolysate, and Tween^®-28 could significantly reduce its irritation in an animal model. The same ingredients from different sources led to inconsistent irritation results. This suggests that manufacturing processes of raw materials, in addition to their chemical properties, concentration, and combination methods, all influence the ocular irritation potential. This study provides key scientific evidence for assessing ocular irritation and developing low-irritation formulations in baby bath products, thereby enhancing product safety.