and mean body weights in all animals increased for the remaining observation period. The notified chemical is of low toxicity via inhalation. Huntingdon (2014f) Irritation skin (in vitro) – Notified chemical OECD TG 431 In vitro Skin Corrosion - Human Skin Model Test EpiDermTM Reconstructed Human Epidermis Model Vehicle Water Remarks - Method No significant protocol deviations. GLP compliance. Positive (8.0 N potassium hydroxide) and negative (purified water) controls were run concurrently with test items. As MTT (3-(4,5-dimethylthiazol-2-yl)-2, 5-diphenyltetrazolium bromide) was reduced by the test substance, freeze killed tissues (no metabolic activity) were included in the assay together with the live tissues as a control. Test material Exposure time Mean OD540 of Relative mean SD of relative (min) triplicate tissues Viability (%) mean viability 3 1.759 100.0 7.3 Negative control 60 2.194 100.0 15.1 3 2.123 120.7 9.2 Test substance 60 2.288 104.3 4.4 3 0.205 11.7 0.4 Positive control 60 0.043 2.0 0.2 OD = optical density; SD = standard deviation Remarks - Results Positive and negative controls performed as expected. The notified chemical was non-corrosive to the skin under the conditions of the test. Huntingdon (2014g) Irritation skin (in vitro) – Notified chemical OECD TG 439 In vitro Skin Irritation: Reconstructed Human Epidermis Test Method EpiSkinTM Reconstituted Human Epidermis Model Vehicle Water Remarks - Method No significant protocol deviations. GLP compliance Positive (5% sodium dodecyl sulphate) and negative (Dulbecco’s phosphate buffered saline) controls were run concurrently with test items. Test material Mean OD540 of triplicate Relative mean SD of relative mean tissues Viability (%) viability
and mean body weights in all animals increased for the remaining observation period. The notified chemical is of low toxicity via inhalation. Huntingdon (2014f) Irritation – skin (in vitro) Notified chemical OECD TG 431 In vitro Skin Corrosion - Human Skin Model Test EpiDermTM Reconstructed Human Epidermis Model Vehicle Water Remarks - Method No significant protocol deviations. GLP compliance. Positive (8.0 N potassium hydroxide) and negative (purified water) controls were run concurrently with test items. As MTT (3-(4,5-dimethylthiazol-2-yl)-2, 5-diphenyltetrazolium bromide) was reduced by the test substance, freeze killed tissues (no metabolic activity) were included in the assay together with the live tissues as a control. Test material Exposure time (min) Mean OD540 of triplicate tissues Relative mean Viability (%) SD of relative mean viability Negative control 3 1.759 100.0 7.3 60 2.194 100.0 15.1 Test substance 3 2.123 120.7 9.2 60 2.288 104.3 4.4 Positive control 3 0.205 11.7 0.4 60 0.043 2.0 0.2 OD = optical density; SD = standard deviation Remarks - Results Positive and negative controls performed as expected. The notified chemical was non-corrosive to the skin under the conditions of the test. Huntingdon (2014g) Irritation – skin (in vitro) Notified chemical OECD TG 439 In vitro Skin Irritation: Reconstructed Human Epidermis Test Method EpiSkinTM Reconstituted Human Epidermis Model Vehicle Water Remarks - Method No significant protocol deviations. GLP compliance Positive (5% sodium dodecyl sulphate) and negative (Dulbecco’s phosphate buffered saline) controls were run concurrently with test items. Test material Mean OD540 of triplicate tissues Relative mean Viability (%) SD of relative mean viability