Lesion Mean Score* Maximum Maximum Maximum Value at Animal No. Duration of Any End of Observation Effect Period 1 2 3 0 0 0 0 0 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. Remarks - Results No skin reactions were observed for the test animals. There was no systemic intolerance reactions noted. Additional observations after 72 hours post patch removal to assess the reversibility of skin reactions were waived, as none of the test animals showed any significant test-item related lesions at the preceding time point observations. The notified chemical is non-irritating to the skin under the test conditions. LPT (2008) Irritation eye – Notified chemical Exxaro Sulphate Slag, UGI (Upgraded Ilmenite) – OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 2004/73/EC B.5 Toxicity (Eye Irritation). Species/Strain Rabbit/Himalayan Number of Animals 3 M Observation Period 72 hours Remarks - Method GLP certificate. Single ocular instillation into the right eye of the test animals with100 mg of the test material. Observations were taken at 1, 24, 48 and 72 hours post-dosing. The Draize Scoring system was used to the eye reaction observations. Lesion Mean Score* Maximum Maximum Maximum Value at End Animal No. Value Duration of Any of Observation Period Effect 1 2 3 0.25 0.25 0.25 1 1 hour 0 Conjunctiva: redness 0 0 0 0 0 0 Conjunctiva: chemosis 0 0 0 0 0 0 Corneal opacity 0 0 0 0 0 0 Iridial inflammation *Calculated on the of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results 1 conjunctival redness and secretion was observed in all animals 1 hour after instillation. The corneae and the irises were not affected by instillation of the test item. The fluorescein test performed 24 hours after instillation did not reveal any changes. There were no systemic intolerance reactions. The notified chemical is non-irritating to the eye under the conditions of the test. LPT (2008)
Lesion Mean Score* Animal No. Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Erythema/Eschar 0 0 0 0 0 0 Oedema 0 0 0 0 0 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results No skin reactions were observed for the test animals. There was no systemic intolerance reactions noted. Additional observations after 72 hours post patch removal to assess the reversibility of skin reactions were waived, as none of the test animals showed any significant test-item related lesions at the preceding time point observations. The notified chemical is non-irritating to the skin under the test conditions. LPT (2008) Irritation – eye Notified chemical – Exxaro Sulphate Slag, UGI (Upgraded Ilmenite) OECD TG 405 Acute Eye Irritation/Corrosion. EC Directive 2004/73/EC B.5 Toxicity (Eye Irritation). Species/Strain Rabbit/Himalayan Number of Animals 3 M Observation Period 72 hours Remarks - Method GLP certificate. Single ocular instillation into the right eye of the test animals with100 mg of the test material. Observations were taken at 1, 24, 48 and 72 hours post-dosing. The Draize Scoring system was used to the eye reaction observations. Lesion Mean Score* Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 0.25 0.25 0.25 1 1 hour 0 Conjunctiva: chemosis 0 0 0 0 0 0 Corneal opacity 0 0 0 0 0 0 Iridial inflammation 0 0 0 0 0 0 *Calculated on the of the scores at 24, 48, and 72 hours for EACH animal. Remarks - Results 1 conjunctival redness and secretion was observed in all animals 1 hour after instillation. The corneae and the irises were not affected by instillation of the test item. The fluorescein test performed 24 hours after instillation did not reveal any changes. There were no systemic intolerance reactions. The notified chemical is non-irritating to the eye under the conditions of the test. LPT (2008)
STD-1504-FR-FINAL.docx