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Health risk assessment for pediatric population associated with ethanol and selected residual solvents in herbal
Branislava Srdjenovic1, Ljilja Torovic2, Nebojsa Kladar1
1University of Novi Sad, Faculty of Medicine, Department of Pharmacy, Hajduk Veljkova 3, 21000 Novi Sad, Serbia; University of Novi Sad, Faculty of Medicine, Center for Medical and Pharmaceutical Investigations and Quality Control, Hajduk Veljkova 3, 21000 Novi Sad, Serbia.
Abstract:
In this study, 48 herbal based products (41 for the pediatric population) were analyzed for the presence of ethanol and residual solvents. Ethanol was not detected in only 12% of the products designed for infants or toddlers aged under 2, and not quantified in only 5 of 14 'alcohol free' products. Actual content was higher than labeled in six out of 11 samples with specified ethanol quantity. WHO proposed requirement for ethanol content in products intended for use in children under the age of 6 (<0.5%) was not met by as many as 26 samples. Furthermore, calculated blood alcohol levels in children exceeded the relevant toxicological levels for nine samples following a single dose, and for one sample in case of accidental poisoning with the entire package. Regarding the residual solvents, acetone, 1-propanol and 1-butanol were not quantified, 2-propanol was found in two samples in low concentrations, whereas methanol intake via one of the samples exceeded the permitted level for children. The obtained results revealed a significant health concern for the pediatric population due to ethanol intake via herbal based products, calling for the establishment of strict guidelines for ethanol content and labeling.
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