Number of Animals 3 Observation Period 8 days. Remarks - Method No protocol deviations. Lesion Mean Score* Maximum Maximum Duration Maximum Value at End Animal No. Value of Any Effect of Observation Period 1 2 3 0 2 1 2 72 hours 0 Conjunctiva: redness 0 0 0 0 Conjunctiva: chemosis 0 0 0 0 Conjunctiva: discharge 0 0 0 0 Corneal opacity 0 0 0 0 Iridial inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results None. The notified chemical is slightly irritating to the eye. (HLS, 2004f). 7.6. Skin sensitisation mouse local lymph node assay (LLNA) – Notified chemical. Species/Strain Mouse/CBA/Ca Vehicle 4:1 oil Remarks - Method No protocol deviations. Proliferative response Stimulation Index Concentration (DPM/lymph node) (Test/Control (% w/v) Test Substance 0 (vehicle control) 460.9 5 545.7 1.2 10 1244.4 2.7 25 458.0 1.0 Positive Control (HCA) 0 136.7 10 208.4 1.5 25 478.6 3.5 50 800.5 5.9 Remarks - Results The positive control data was at the low end of the of historical data. was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical. (HLS, 2004g). 7.7. Repeat dose toxicity Notified chemical.
Number of Animals 3 Observation Period 8 days. Remarks - Method No protocol deviations. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 0 2 1 2 72 hours 0 Conjunctiva: chemosis 0 0 0 0 Conjunctiva: discharge 0 0 0 0 Corneal opacity 0 0 0 0 Iridial inflammation 0 0 0 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results None. The notified chemical is slightly irritating to the eye. (HLS, 2004f). 7.6. Skin sensitisation – mouse local lymph node assay (LLNA) Notified chemical. Species/Strain Mouse/CBA/Ca Vehicle 4:1 oil Remarks - Method No protocol deviations. Concentration (% w/v) Proliferative response (DPM/lymph node) Stimulation Index (Test/Control Test Substance 0 (vehicle control) 460.9 5 545.7 1.2 10 1244.4 2.7 25 458.0 1.0 Positive Control (HCA) 0 136.7 10 208.4 1.5 25 478.6 3.5 50 800.5 5.9 Remarks - Results The positive control data was at the low end of the of historical data. was no evidence of induction of a lymphocyte proliferative response indicative of skin sensitisation to the notified chemical. (HLS, 2004g). 7.7. Repeat dose toxicity Notified chemical.
STD1178FR.docx