Bilastine: an environmental risk assessment
| Autor: | Francisco Ledo, Armin Peither, María Luisa Lucero |
|---|---|
| Rok vydání: | 2015 |
| Předmět: |
Male
Histamine H1 Antagonists Non-Sedating Health Toxicology and Mutagenesis medicine.medical_treatment Symptomatic treatment Pharmacology Toxicology Risk Assessment Chironomidae chemistry.chemical_compound Human use Piperidines Chlorophyta medicine Animals Zebrafish Environmental risk assessment Bilastine No-Observed-Adverse-Effect Level Chemical Health and Safety Sewage business.industry Public Health Environmental and Occupational Health General Medicine chemistry Daphnia Aquatic environment Antihistamine Benzimidazoles Female business Water Pollutants Chemical Potential toxicity Environmental Monitoring |
| Zdroj: | Drug and chemical toxicology. 38(4) |
| ISSN: | 1525-6014 |
| Popis: | Bilastine is a new oral selective, non-sedating histamine H1 antagonist for the symptomatic treatment of allergic rhinoconjunctivitis and urticaria. The European Medicines Agency requires an Environmental Risk Assessment (ERA) for all novel medicines for human use.To calculate the bilastine predicted environmental concentration in surface water (PECsw; phase I ERA), and to determine the effects of bilastine on aquatic systems (phase II [tier A]).Bilastine PECsw was calculated using the maximum daily dosage (20 mg), assuming that all administered bilastine was released into the aquatic environment. A persistence, bioaccumulation and toxicity assessment was conducted using the log Kow from the molecular structure. In phase II (tier A), a ready biodegradability test was performed, and bilastine's potential toxicity to various aquatic and sediment-dwelling micro-organisms was evaluated.Bilastine PECSW was calculated as 0.1 μg L(-1), and the compound was not readily biodegradable. Bilastine had no significant effects on Chironomus riparius midges, or on the respiration rate of activated sludge. For green algae, the bilastine no observed effect concentration (NOEC) was 22 mg L(-1); bilastine had no effect on zebra fish development, or on the reproduction rate of daphnids.Bilastine NOEC values against zebra fish, algae, daphnids, and aerobic organisms in activated sludge were at least 130 000-fold greater than the calculated PECSW value.No environmental concerns exist from bilastine use in patients with allergic rhinoconjunctivitis or urticaria. |
| Databáze: | OpenAIRE |
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