Lesion Mean Score* Maximum Maximum Maximum Value at End Animal No. Duration of Any of Observation Period Effect 1 2 3 1.33 0.67 0 2 3 days 0 Conjunctiva: redness 0 0 0 0 0 0 Conjunctiva: chemosis Conjunctiva: discharge 0 0 0 0 0 0 Corneal opacity 0 0 0 0 0 0 Iridial inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. The notified chemical is slightly irritating to the eye. Huntingdon Life Sciences 7.5. Skin sensitisation Notified chemical. OECD TG 406 Skin Sensitisation maximisation test. – EC Directive 96/54/EC B.6 Skin Sensitisation - maximisation. Species/Strain Guinea pig/Dunkin-Hartley. preliminary study Maximum Non-irritating Concentration: intradermal: 5% (w/v) topical: 65% (w/v) main study Number of Animals Test Group: 10 Control Group: 5 induction phase Induction Concentration: intradermal: 5% (w/v) topical: 65% (w/v) Signs of Irritation None due to notified chemical. challenge phase 1st challenge topical: 32.5% (w/v), 65% (w/v) Remarks - Method No significant deviations from protocol. Remarks - Results No sensitisation reactions were observed in any animal at either challenge concentration at either 24 or 48 hours after patch removal. There was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test. Huntingdon Life Sciences (2002f). 7.7. Repeat dose toxicity Notified chemical. OECD TG 407 Repeated Dose 28-day Oral Toxicity in Rodents. OPPTS 870.3050, July 2000. Species/Strain Rat/Crl: CD SD IGS BR. Route of Administration Oral gavage. – Exposure Information Total exposure days: 28 days; Dose regimen: 7 days per week. Vehicle Corn oil.
Lesion Mean Score* Animal No. Maximum Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 1.33 0.67 0 2 3 days 0 Conjunctiva: chemosis 0 0 0 0 0 0 Conjunctiva: discharge Corneal opacity 0 0 0 0 0 0 Iridial inflammation 0 0 0 0 0 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. The notified chemical is slightly irritating to the eye. Huntingdon Life Sciences 7.5. Skin sensitisation Notified chemical. OECD TG 406 Skin Sensitisation – maximisation test. EC Directive 96/54/EC B.6 Skin Sensitisation - maximisation. Species/Strain Guinea pig/Dunkin-Hartley. preliminary study Maximum Non-irritating Concentration: intradermal: 5% (w/v) topical: 65% (w/v) main study Number of Animals Test Group: 10 Control Group: 5 induction phase Induction Concentration: intradermal: 5% (w/v) topical: 65% (w/v) Signs of Irritation None due to notified chemical. challenge phase 1st challenge topical: 32.5% (w/v), 65% (w/v) Remarks - Method No significant deviations from protocol. Remarks - Results No sensitisation reactions were observed in any animal at either challenge concentration at either 24 or 48 hours after patch removal. There was no evidence of reactions indicative of skin sensitisation to the notified chemical under the conditions of the test. Huntingdon Life Sciences (2002f). 7.7. Repeat dose toxicity Notified chemical. OECD TG 407 Repeated Dose 28-day Oral Toxicity in Rodents. OPPTS 870.3050, July 2000. Species/Strain Rat/Crl: CD SD IGS BR. Route of Administration Oral – gavage. Exposure Information Total exposure days: 28 days; Dose regimen: 7 days per week. Vehicle Corn oil.
STD1112FR.docx