B.4. Irritation eye – Notified chemical OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 2004/73/EC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New White Number of Animals 3 Males Observation Period 72 hours (7 days for one animal) Remarks - Method No significant deviation from the protocol. A Rabbit Enucleated Eye Test (REET) was conducted prior to the eye irritation study, which indicated that the notified chemical was unlikely to cause severe ocular irritancy. Lesion Mean Score* Maximum Maximum Maximum Value at End Animal No. Value Duration of Any of Observation Period Effect 1 2 3 1.67 1 0.67 2 <7 d 0 Conjunctiva: redness 0.67 0.33 0.33 1 <48 h 0 Conjunctiva: chemosis 0 0 0.67 1 <72 h 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. Remarks - Results Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 and 48-hour observations, except in one treated eye at the 72-hour observation. No effects to the cornea or iris were observed in the study. The notified chemical is slightly irritating to the eye. Safepharm (2006f) B.5 Skin sensitisation mouse local lymph node assay (LLNA) – Notified chemical OECD TG 429 Skin Sensitisation - Local lymph node assay EC Directive 2004/73/EC B.42 Skin Sensitisation - Local lymph node assay. Species/Strain Mouse CBA/CaBkl (Females) Vehicle Butanone Remarks - Method No significant deviation from the protocol. A preliminary screening test was conducted using the test material at concentrations of 10%, 25% and 50% in butanone. Based on the result, the test material at concentrations of 2.5%, 5% and 10% in butanone was selected for the main test. Proliferative response Stimulation Index Concentration (DPM/lymph node) (Test/Control Ratio) (% w/w) Test Substance 0 (vehicle control) 737.97 (± 275.87) n/a
B.4. Irritation – eye Notified chemical OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 2004/73/EC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New White Number of Animals 3 Males Observation Period 72 hours (7 days for one animal) Remarks - Method No significant deviation from the protocol. A Rabbit Enucleated Eye Test (REET) was conducted prior to the eye irritation study, which indicated that the notified chemical was unlikely to cause severe ocular irritancy. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 1.67 1 0.67 2 <7 d 0 Conjunctiva: chemosis 0.67 0.33 0.33 1 <48 h 0 Conjunctiva: discharge 0 0 0.67 1 <72 h 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. Remarks - Results Minimal to moderate conjunctival irritation was noted in all treated eyes one hour after treatment and at the 24 and 48-hour observations, except in one treated eye at the 72-hour observation. No effects to the cornea or iris were observed in the study. The notified chemical is slightly irritating to the eye. Safepharm (2006f) B.5 Skin sensitisation – mouse local lymph node assay (LLNA) Notified chemical OECD TG 429 Skin Sensitisation - Local lymph node assay EC Directive 2004/73/EC B.42 Skin Sensitisation - Local lymph node assay. Species/Strain Mouse CBA/CaBkl (Females) Vehicle Butanone Remarks - Method No significant deviation from the protocol. A preliminary screening test was conducted using the test material at concentrations of 10%, 25% and 50% in butanone. Based on the result, the test material at concentrations of 2.5%, 5% and 10% in butanone was selected for the main test. Concentration (% w/w) Proliferative response (DPM/lymph node) Stimulation Index (Test/Control Ratio) Test Substance 0 (vehicle control) 737.97 (± 275.87) n/a
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