Non Animal Testing, Alternative Test Methods, In Vitro Toxicology, IIVS | Shipping Study to Evaluate the Performance of the LabCyte EPI-MODEL 24 Tissues for Use in the Skin Irritation Test (OECD TG 439) After Long-Haul Airfreight
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Shipping Study to Evaluate the Performance of the LabCyte EPI-MODEL 24 Tissues for Use in the Skin Irritation Test (OECD TG 439) After Long-Haul Airfreight

March 18, 2019

It is recommended that an evaluation of the impact of shipping of Reconstructed human Epidermis (RhE) tissues be conducted especially after long-haul airfreight shipments. The OECD Test
Guideline 439 (OECD TG 439), In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method, recommends that users do so by verifying the barrier properties of the tissues after receipt. In this study, LabCyte EPI-MODEL 24 tissues were received in the USA after an overnight shipment from Japan and were tested to evaluate their performance after shipment using several endpoints. First, the viability of untreated tissues incubated overnight in culture medium was assessed using the vital dye MTT and expressed as Optical Density (OD570-650) values. The calculated OD values were 1.2 (J-TEC) and 0.99 (IIVS) and within the range established by the manufacturer (0.8 – 2.5). The barrier function was further evaluated after the tissues were exposed to the assay negative control (Phosphate Buffered Saline – PBS) and to four concentrations of the positive control, Sodium Lauryl Sulfate (SLS) (1.0, 2.0, 3.0 and 4.0 mg/mL). The calculated IC50 values were 2.7 mg/mL (J-TEC) and 3.4 mg/mL (IIVS), respectively, and within the established historical range (1.4 – 4.0 mg/mL). The analysis of the results generated by the two labs (J-TEC and IIVS) demonstrated that the tissue lot met the acceptance criteria developed by the tissue manufacturer under conditions of shipping stress. Finally, the histological analysis of untreated fixed tissues identified all tissue layers and supported the conclusion that the tissue model was acceptable for use in subsequent studies after long-haul airfreight shipment. Such shipping studies are critical to gaining confidence in the tissues’ performance when used for research, industrial, and regulatory testing purposes.