Treated-rinsed Lesion Mean Score* Maximum Maximum Duration Maximum at End Value of Any Effect of Observation Period 0 1 < 24 hours 0 Conjunctiva: redness 0 0 - 0 Conjunctiva: chemosis 0 1 < 24 0 Conjunctiva: discharge 0 0 - 0 Corneal opacity 0 0 - 0 Iridial inflammation *Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals. Remarks - Results Both the treated-unrinsed and the treated-rinsed eyes showed slight conjunctival irritation 1 hour exposure. All eyes were clear by 24 hours after treatment. The test substance is slightly irritating to the eye. Chevron (1982a) Skin sensitisation Analogue 2 OECD TG 406 Skin Sensitisation - Magnusson and Kligman Species/Strain Guinea pig/ albino Hartley preliminary study Maximum Non-irritating Concentration: intradermal: 1% in peanut oil topical: 5% in peanut oil main study Number of Animals Test Group: 20 Control Group: 19 (20 at onset of study, mortality accounted for decrease) induction Induction Concentration: intradermal: 1% in peanut oil topical: 5% in peanut oil mixed with 0.5 g petrolatum of Irritation challenge phase topical: 0.2% in peanut oil mixed with 0.5 g petrolatum Remarks - Method The concentrations of the test substance used in the main were determined in a preliminary study. The negative control for challenge was 0.2 g peanut oil. The positive control was ethylenediamine. The test animals received two induction treatments, an intradermal injection on day 0 and a topical application on day 7. Animal Challenge Concentration Number of Animals Showing Skin Reactions after: challenge 24 h 48 h 1% 0/20 0/20 Test Group 1% 0/15* 0/15* Negative Control 10% 16/18 17/17# Positive Control * Four animals excluded from counting as irritation was observed on both the treated and control flanks. # one animal excluded from counting as irritation was observed on both the treated and control flanks. - One animal in the negative control and two animals in the positive control died within 48 hours of the topical induction. There were no remarkable body weight changes in surviving animals during the study. There was no evidence of reactions indicative of skin sensitisation to the test substance under the conditions of the test.
Treated-rinsed Lesion Mean Score* Maximum Value Maximum Duration of Any Effect Maximum at End of Observation Period Conjunctiva: redness 0 1 < 24 hours 0 Conjunctiva: chemosis 0 0 - 0 Conjunctiva: discharge 0 1 < 24 0 Corneal opacity 0 0 - 0 Iridial inflammation 0 0 - 0 *Calculated on the basis of the scores at 24, 48, and 72 hours for ALL animals. Remarks - Results Both the treated-unrinsed and the treated-rinsed eyes showed slight conjunctival irritation 1 hour exposure. All eyes were clear by 24 hours after treatment. The test substance is slightly irritating to the eye. Chevron (1982a) Skin sensitisation Analogue 2 OECD TG 406 Skin Sensitisation - Magnusson and Kligman Species/Strain Guinea pig/ albino Hartley preliminary study Maximum Non-irritating Concentration: intradermal: 1% in peanut oil topical: 5% in peanut oil main study Number of Animals Test Group: 20 Control Group: 19 (20 at onset of study, mortality accounted for decrease) induction Induction Concentration: intradermal: 1% in peanut oil topical: 5% in peanut oil mixed with 0.5 g petrolatum of Irritation challenge phase topical: 0.2% in peanut oil mixed with 0.5 g petrolatum Remarks - Method The concentrations of the test substance used in the main were determined in a preliminary study. The negative control for challenge was 0.2 g peanut oil. The positive control was ethylenediamine. The test animals received two induction treatments, an intradermal injection on day 0 and a topical application on day 7. Animal Challenge Concentration Number of Animals Showing Skin Reactions after: challenge 24 h 48 h Test Group 1% 0/20 0/20 Negative Control 1% 0/15* 0/15* Positive Control 10% 16/18 17/17# * Four animals excluded from counting as irritation was observed on both the treated and control flanks. # one animal excluded from counting as irritation was observed on both the treated and control flanks. - One animal in the negative control and two animals in the positive control died within 48 hours of the topical induction. There were no remarkable body weight changes in surviving animals during the study. There was no evidence of reactions indicative of skin sensitisation to the test substance under the conditions of the test.
STD1540-FR-FINAL.DOCX