Hello, we are planning a biological evaluation for a single use component. The component will apply to the mucousal membran for a short time (<10 minutes). We are planning a chemical characterization according to ISO 10993-12 / -18 and 17. Additional we are planning a cytotoxicity test according to ISO 10993-5. In accordance to ISO 10093-1 an irritation and sensibilisation test should be also applied. We would like to avoid the animal tests. We analyzed the raw materials and we don't expect leachable substances above threshold limits. What would be an acceptable justification to avoid the animal tests? Thank you for your assistance.