Irritation skin (in vitro) – Notified chemical. OECD TG 439 In vitro Skin Irritation: Reconstructed Human Epidermis Test Method. Vehicle Used as supplied. Remarks - Method EPISKINTM Reconstructed Human Epidermis Model. No significant protocol deviations. GLP Compliance. Negative and positive controls were used in parallel with the test substance. Test material Mean OD562 of triplicate Relative mean SD of relative mean tissues Viability (%) viability (%) 0.725 Set at 100 5.0 Negative control 0.863 119.1 9.6 Test substance 0.119 16.5 6.0 Positive control OD = optical density; SD = standard deviation Remarks - Results The MTT solution containing the test item did not turn blue, indicating that the test item did not directly reduce MTT. The controls gave responses within the expected range, confirming the validity of the test system. The study authors considered it unnecessary to perform IL-1α analysis as they deemed these results to be unequivocal. The notified chemical was non-irritating to the skin under the conditions of the test. Harlan (2013i) Irritation skin – Notified chemical. OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New Zealand White. Number of Animals 3 Males. Vehicle Test substance administered as supplied. Observation Period 14 days. Type of Dressing Semi-Occlusive. Remarks - Method No significant protocol deviations. GLP Compliance. Skin Reaction Mean Score* Maximum Maximum Duration Maximum Value at End Animal No. Value of Any Effect of Observation Period 1 2 3 0 0 0 1 < 24 hours 0 Erythema/Eschar 0 0 0 0 0 0 Oedema *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.
Irritation – skin (in vitro) Notified chemical. OECD TG 439 In vitro Skin Irritation: Reconstructed Human Epidermis Test Method. Vehicle Used as supplied. Remarks - Method EPISKINTM Reconstructed Human Epidermis Model. No significant protocol deviations. GLP Compliance. Negative and positive controls were used in parallel with the test substance. Test material Mean OD562 of triplicate tissues Relative mean Viability (%) SD of relative mean viability (%) Negative control 0.725 Set at 100 5.0 Test substance 0.863 119.1 9.6 Positive control 0.119 16.5 6.0 OD = optical density; SD = standard deviation Remarks - Results The MTT solution containing the test item did not turn blue, indicating that the test item did not directly reduce MTT. The controls gave responses within the expected range, confirming the validity of the test system. The study authors considered it unnecessary to perform IL-1α analysis as they deemed these results to be unequivocal. The notified chemical was non-irritating to the skin under the conditions of the test. Harlan (2013i) Irritation – skin Notified chemical. OECD TG 404 Acute Dermal Irritation/Corrosion. Species/Strain Rabbit/New Zealand White. Number of Animals 3 Males. Vehicle Test substance administered as supplied. Observation Period 14 days. Type of Dressing Semi-Occlusive. Remarks - Method No significant protocol deviations. GLP Compliance. Skin Reaction Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 0 0 0 1 < 24 hours 0 Oedema 0 0 0 0 0 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal.