Test Method: based on USEPA Health Effects Testing Guidelines (8) Result: diffuse conjunctival redness, discharge and slight chemosis were observed at 1 and 24 hours; all animals were normal by 72 hours except one with slight redness of the conjunctivae; the total Draize scores were 9.7, 5.3, 1.7 and 0.3 at 1, 24, 48 and 72 hours, respectively; the mean score calculated from the 24, 48 and 72 hour readings was 0.7 for conjunctival redness and was 0.3 for chemosis; no effects on the cornea or iris were observed; the test substance was a slight eye irritant in rabbits 9.1.6 Skin Sensitisation (7) Dunkin Hartley albino guinea pig Species/strain: Number of animals: 4 range-finding animals (2/sex), 20 test animals (10/sex), 10 control animals (5/sex), 20 positive control animals (10/sex) Primary irritation: 4 animals were treated topically with 0.4 ml of 25, 50 or 75% test substance (w/w in Squibb Mineral Oil (SMO)) for 6 hours under occluded patches; skin reactions were assessed after 22 hours; the highest non-irritating concentration was determined to be 50%; 75% test substance produced slight irritation Induction procedure: 0.3 ml of test substance (75% w/w in SMO) was applied by occluded patch (6 hours) to the test guinea pigs once a week for 3 weeks; half the positive control animals were treated with 0.4 ml of 2,4-dinitrochlorobenzene (DNCB)(0.05% w/v in 80% ethanol); one test animal was found dead during induction phase, necropsy showed no treatment-related cause Challenge procedure: 16 days after the last induction dose 0.3 ml of test substance (50% w/w in SMO) was applied to the test and control animals; all positive control animals were treated with DNCB (0.05% w/v in acetone) Challenge outcome:
Test Method: based on USEPA Health Effects Testing Guidelines (8) Result: diffuse conjunctival redness, discharge and slight chemosis were observed at 1 and 24 hours; all animals were normal by 72 hours except one with slight redness of the conjunctivae; the total Draize scores were 9.7, 5.3, 1.7 and 0.3 at 1, 24, 48 and 72 hours, respectively; the mean score calculated from the 24, 48 and 72 hour readings was 0.7 for conjunctival redness and was 0.3 for chemosis; no effects on the cornea or iris were observed; the test substance was a slight eye irritant in rabbits 9.1.6 Skin Sensitisation (7) Species/strain: Dunkin Hartley albino guinea pig Number of animals: 4 range-finding animals (2/sex), 20 test animals (10/sex), 10 control animals (5/sex), 20 positive control animals (10/sex) Primary irritation: 4 animals were treated topically with 0.4 ml of 25, 50 or 75% test substance (w/w in Squibb Mineral Oil (SMO)) for 6 hours under occluded patches; skin reactions were assessed after 22 hours; the highest non-irritating concentration was determined to be 50%; 75% test substance produced slight irritation Induction procedure: 0.3 ml of test substance (75% w/w in SMO) was applied by occluded patch (6 hours) to the test guinea pigs once a week for 3 weeks; half the positive control animals were treated with 0.4 ml of 2,4-dinitrochlorobenzene (DNCB)(0.05% w/v in 80% ethanol); one test animal was found dead during induction phase, necropsy showed no treatment-related cause Challenge procedure: 16 days after the last induction dose 0.3 ml of test substance (50% w/w in SMO) was applied to the test and control animals; all positive control animals were treated with DNCB (0.05% w/v in acetone) Challenge outcome:
NA298FR.docx