The inseparable mixture of the notified chemicals was not corrosive or a severe eye irritant under the conditions of the test. Harlan Irritation eye – Inseparable mixture of the notified chemicals OECD TG 405 Acute Eye Irritation/Corrosion Species/Strain Rabbit/New Zealand White (Hsdlf) Number of Animals 3 Observation Period 72 hours Remarks - Method No significant protocol deviations. Lesion Mean Score* Maximum Maximum Maximum Value at End Animal No. Duration of Any of Observation Period Effect 1 2 3 1.0 0.3 0.3 2 <72 0 Conjunctiva: redness 0.3 0 0.3 2 <48 hours 0 Conjunctiva: chemosis 0 0 0 1 <24 hours 0 Conjunctiva: discharge 0 0 0 0 - 0 Corneal opacity 0 0 0 0 - 0 Iridial inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. The inseparable mixture of the notified chemicals is slightly irritating to the eye. Harlan (2012i) Skin sensitisation mouse local lymph node assay (LLNA) – Inseparable mixture of the notified chemicals OECD TG 429 Skin Sensitisation: Local Lymph Node Assay Species/Strain Mouse/CBA/Ca Vehicle 1% pluronic L92 in distilled Remarks - Method The highest tested concentration of 10% was noted as being the maximum attainable concentration that was suitable for dosing, although it was not stated whether this was due to solubility or homogeneity. This concentration did not produce systemic toxicity or excessive local irritation in a preliminary screening test. Proliferative response Stimulation Index Concentration (DPM/animal) (Test/Control Ratio) (% w/w) Test Substance 0 (vehicle control) 1177 443 1.00 2.5 1811 487 1.54 5 1179 457 1.00 10 1194 308 1.01 Positive Control (HCA) 85 10957 2949 9.31 Data presented as mean standard deviation HCA, hexylcinnamaldehyde
The inseparable mixture of the notified chemicals was not corrosive or a severe eye irritant under the conditions of the test. Harlan Irritation – eye Inseparable mixture of the notified chemicals OECD TG 405 Acute Eye Irritation/Corrosion Species/Strain Rabbit/New Zealand White (Hsdlf) Number of Animals 3 Observation Period 72 hours Remarks - Method No significant protocol deviations. Lesion Mean Score* Animal No. Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 1.0 0.3 0.3 2 <72 0 Conjunctiva: chemosis 0.3 0 0.3 2 <48 hours 0 Conjunctiva: discharge 0 0 0 1 <24 hours 0 Corneal opacity 0 0 0 0 - 0 Iridial inflammation 0 0 0 0 - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. The inseparable mixture of the notified chemicals is slightly irritating to the eye. Harlan (2012i) Skin sensitisation – mouse local lymph node assay (LLNA) Inseparable mixture of the notified chemicals OECD TG 429 Skin Sensitisation: Local Lymph Node Assay Species/Strain Mouse/CBA/Ca Vehicle 1% pluronic L92 in distilled Remarks - Method The highest tested concentration of 10% was noted as being the maximum attainable concentration that was suitable for dosing, although it was not stated whether this was due to solubility or homogeneity. This concentration did not produce systemic toxicity or excessive local irritation in a preliminary screening test. Concentration (% w/w) Proliferative response (DPM/animal) Stimulation Index (Test/Control Ratio) Test Substance 0 (vehicle control) 1177 443 1.00 2.5 1811 487 1.54 5 1179 457 1.00 10 1194 308 1.01 Positive Control (HCA) 85 10957 2949 9.31 Data presented as mean standard deviation HCA, hexylcinnamaldehyde
STD-1474-FR.docx