6 0* 0 0* 0 0* 0 0 0 0 0 All animals scored zero Iris Conjunctiva r c d r c d r c d r c d r c d 1 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 2 2 1 0 1 0 0 1 0 0 0 0 0 0 0 0 3 1 1 0 1 1 0 1 1 0 1 0 0 0 0 0 4 1 0 0 1 0 0 1 0 0 1 0 0 0 0 0 5 1 1 0 1 0 0 0 0 0 0 0 0 0 0 0 6 1 1 0 1 1 0 1 0 0 0 0 0 0 0 0 1 see Attachment 1 for Draize scales * no apparent opacity; cornea stained light-red to dark purple which resolved by day 4 o = opacity a = area r = redness c = chemosis d = discharge No staining was evident in all animals when fluorescein dye Comment: was applied to the eyes at 24 and 72 hours, and day 7. All treated eyes returned to normal by day 7 the notified chemical was slightly irritating to the eyes of Result: rabbits 9.1.6 Skin Sensitisation (Glaza MS, 1993b) Guinea pigs/Crl: (HA)BR Species/strain: Control 10 Number of animals: Test group: 20 Induction procedure: test group: Intradermal Induction: day 1 pairs of intradermal injections (0.1mL) across the shoulder region of the animals: Freund’s complete adjuvant (FCA) 1:1 in sterile water 5% w/v notified chemical in sterile water 5% w/v notified chemical in a 1:1 mixture of FCA and sterile water day 7 Local Irritation: Animals pre-treated with 10% w/w sodium lauryl sulphate in petrolatum at the induction site day 8 Topical Induction: A 48-hour occluded application of 25% w/w notified chemical in petrolatum to the test area.
6 0* 0 0* 0 0* 0 0 0 0 0 Iris All animals scored zero Conjunctiva r c d r c d r c d r c d r c d 1 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 2 2 1 0 1 0 0 1 0 0 0 0 0 0 0 0 3 1 1 0 1 1 0 1 1 0 1 0 0 0 0 0 4 1 0 0 1 0 0 1 0 0 1 0 0 0 0 0 5 1 1 0 1 0 0 0 0 0 0 0 0 0 0 0 6 1 1 0 1 1 0 1 0 0 0 0 0 0 0 0 1 see Attachment 1 for Draize scales * no apparent opacity; cornea stained light-red to dark purple which resolved by day 4 o = opacity a = area r = redness c = chemosis d = discharge Comment: No staining was evident in all animals when fluorescein dye was applied to the eyes at 24 and 72 hours, and day 7. All treated eyes returned to normal by day 7 Result: the notified chemical was slightly irritating to the eyes of rabbits 9.1.6 Skin Sensitisation (Glaza MS, 1993b) Species/strain: Guinea pigs/Crl: (HA)BR Number of animals: Control 10 Test group: 20 Induction procedure: test group: day 1 day 7 day 8 Intradermal Induction: pairs of intradermal injections (0.1mL) across the shoulder region of the animals: Freund’s complete adjuvant (FCA) 1:1 in sterile water 5% w/v notified chemical in sterile water 5% w/v notified chemical in a 1:1 mixture of FCA and sterile water Local Irritation: Animals pre-treated with 10% w/w sodium lauryl sulphate in petrolatum at the induction site Topical Induction: A 48-hour occluded application of 25% w/w notified chemical in petrolatum to the test area.
NA925FR.docx