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EC number: 806-924-8 | CAS number: 1391350-92-7
The MatTek Corporation’s EpiDerm™ reconstituted human epidermis model was used to assess the potential skin irritation of the test substance, XU-18838.00, Lot Number 20120135-18. The skin irritation potential of the test substance was evaluated by measuring the relative cell viability in treated tissues at 42-hour post-exposure incubation after a 60-minute exposure to the test substance, according to the Protocol for: In vitro EpiDerm™skin irritation test (EPI-200-SIT) 1 evaluated and validated by the European Centre for the Validation of Alternative Methods (ECVAM). The protocol met the requirements of the OECD guideline, “In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method” (TG 439)2. Under the conditions specified in this study, the test substance, XU-18838.00, resulted in 97.2% cell viability and was not predicted to be a skin irritant. Results of the positive control and negative control met the criteria of a valid assay. Accordingly, the test substance, XU-18838.00, would be labeled non-irritant to skin (i.e., “no category”) within the Globally Harmonized System, or “No label” within the context of the European Risk Phrase system.
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