Remarks Results Slight erythema occurred in treated skin areas of the 3 rabbits 1 hour after – application only. No symptoms of systemic toxicity were observed and no mortality occurred. Yellow staining was observed throughout the study. The notified chemical is non-irritating to skin. NOTOX B.V (1999m). 7.5. Irritation eye – Notified chemical OECD TG 405 Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 72 h Remarks Method No significant protocol deviations – Lesion Mean Maximum Maximum Maximum Value at Animal No. Value Duration of Any End of Observation Effect Period 1 2 3 0.3 0.3 0.3 2 <48h 0 Conjunctiva: redness 0 0 0 1 <24h 0 Conjunctiva: chemosis 0 0 0 1 0 0 Conjunctiva: discharge 0 0 0 0 0 0 Corneal opacity 0 0 0 1 <24h 0 Iridial inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks Results Iridal irritation occurred in one animal 1 hour after installation only. – Conjunctival irritation consisted of redness, chemosis and discharge which completely resolved within 48 hours in all animals. No staining of ocular tissues was reported. The notified chemical is non-irritating to the eye. NOTOX B.V (1999n). 7.6. Skin sensitisation Notified chemical OECD TG 406 Skin Sensitisation - Maximisation test. EC Directive 96/54/EC B.6 Skin Sensitisation - Maximisation test. Species/Strain Guinea pig/ Dunkin Hartley preliminary study Maximum Non-irritating Concentration: intradermal: <2% topical: 5% main study Number of Animals Test Group: 10 Control Group: 5 induction Induction Concentration: intradermal injection 2% in water/ 2% in FCA:Water 1:1 topical application 20% in vaseline
Remarks – Results Slight erythema occurred in treated skin areas of the 3 rabbits 1 hour after application only. No symptoms of systemic toxicity were observed and no mortality occurred. Yellow staining was observed throughout the study. The notified chemical is non-irritating to skin. NOTOX B.V (1999m). 7.5. Irritation – eye Notified chemical OECD TG 405 Eye Irritation/Corrosion. EC Directive 92/69/EEC B.5 Acute Toxicity (Eye Irritation). Species/Strain Rabbit/New Zealand White Number of Animals 3 Observation Period 72 h Remarks – Method No significant protocol deviations Lesion Mean Animal No. Maximum Value Maximum Duration of Any Effect Maximum Value at End of Observation Period 1 2 3 Conjunctiva: redness 0.3 0.3 0.3 2 <48h 0 Conjunctiva: chemosis 0 0 0 1 <24h 0 Conjunctiva: discharge 0 0 0 1 0 0 Corneal opacity 0 0 0 0 0 0 Iridial inflammation 0 0 0 1 <24h 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for EACH animal. Remarks – Results Iridal irritation occurred in one animal 1 hour after installation only. Conjunctival irritation consisted of redness, chemosis and discharge which completely resolved within 48 hours in all animals. No staining of ocular tissues was reported. The notified chemical is non-irritating to the eye. NOTOX B.V (1999n). 7.6. Skin sensitisation Notified chemical OECD TG 406 Skin Sensitisation - Maximisation test. EC Directive 96/54/EC B.6 Skin Sensitisation - Maximisation test. Species/Strain Guinea pig/ Dunkin Hartley preliminary study Maximum Non-irritating Concentration: intradermal: <2% topical: 5% main study Number of Animals Test Group: 10 Control Group: 5 induction Induction Concentration: intradermal injection 2% in water/ 2% in FCA:Water 1:1 topical application 20% in vaseline
STD1107FR.docx