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EC number: 246-608-1 | CAS number: 25088-57-7
Table 1. Results after treatment with AD-464 and the controls
OD 570 nm
Mean OD of3 Wells
Mean OD of 3 Wells blank corrected
Mean ODof 3 tissues blank corrected
Rel. Viability [%] Tissue 1, 2 + 3*
Mean Rel. Viability [%]*
OECD 439 (2018) - The skin irritation potential of the test item was assessed using a Reconstructed Human Epidermis (RHE) Model Kit in accordance with OECD guidance 439 and GLP.
Triplicate tissues were exposed to the test item for 15 minutes. At the end of the exposure period the test item was rinsed and the tissues incubated for a further 42 h in the presence of maintenance solution which would be used for possible inflammatory mediator determination. Each tissue was then loaded with MTT. After incubation and extraction, the solutions were aliquoted for absorbance measurements. Absorbency at 570 nm of each well was measured using a microplate reader (Versamax® Molecular Devices, Softmax Pro Enterprise, version 4.7.1).
Each three tissues of the human skin model EpiDermTM were treated with the test item, the negative control (DPBS) or the positive control (5% SDS) for 60 minutes.
After treatment with the negative control the absorbance values were well within the required range of the acceptability criterion of mean OD ≥ 0.8 and ≤ 2.8 for the 60 minutes treatment interval, thus assuring the quality of the tissues.
Treatment with the positive control induced a sufficient decrease in the relative absorbance as compared to the negative control for the 60 minutes treatment interval, and thus assuring the validity of the test system.
After treatment with the test item AD-464 the mean relative viability value decreased to 97.78% compared to the relative absorbance value of the negative control. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
In conclusion, it can be stated that in this study and under the experimental conditions reported, AD-464 is non-irritant to skin.
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