Pathology showed discolouration in the liver, enlarged gall bladder and gastrointestinal inflammation in the animals that died. Survivors killed at14 days were normal. Six Rabbit Not irritating The skin of 3 animals was abraded; the Skin irritation skin of the remaining 3 animals was not. The duration of exposure was 24 Animals were observed at 24 and 72 hours following dosing. All readings were negative. Material does not meet the Annex VI (R38) criteria for irritation. Rabbits/ Six Not irritating The dose used was 0.5 ml, with an New Zealand exposure time of 4 hours. The White observation period was 48 hours. Results: OSHA score (0 and 48 hours) = 1.33 A defatting effect was noted. Rabbits/ Six Not irritating The dose used was 0.5 ml, with an New Zealand exposure of 24 hours. The observation period was 7 days. Two male and one female Results: OECD score (0, 24, 48 and 72 hours) = 2.23 OSHA score (0 and 48 hours) = 1.3 A defatting effect was noted. Rabbit Not irritating The undiluted test article was Eye irritation Six animals administered. Animals were observed at 1, 2, 3, 4 and 7 days following treatment. Eyes were scored according to Driaze All readings were negative. Material does not meet the Annex VI (R36) criteria for irritation. Rabbits/ Six Not irritating The dose used was 0.1 ml, with an New Zealand observation period of 72 hours. White Conjunctival redness and swelling were scored. There were no observed effects on the cornea or iris. After 72 hours all effects had disappeared. Rabbits/New Not irritating The dose used was 0.1 ml, with an Zealand White observation period of 7 days. One male and 2 females By day 7 effects had disappeared. Guinea Not sensitising Two male and 2 female animals in the Sensitization – Guinea pig/Hartley positive control group. There was no pig maximization test Albino negative control group. 3 per sex The dose was 0.3 ml of undiluted test material applied for 24 hours every other day for 10 applications. After a two week rest period, the challenge was made using a 24-hour exposure.
Pathology showed discolouration in the liver, enlarged gall bladder and gastrointestinal inflammation in the animals that died. Survivors killed at14 days were normal. Skin irritation Six Rabbit Not irritating The skin of 3 animals was abraded; the skin of the remaining 3 animals was not. The duration of exposure was 24 Animals were observed at 24 and 72 hours following dosing. All readings were negative. Material does not meet the Annex VI (R38) criteria for irritation. Rabbits/ Six New Zealand White Not irritating The dose used was 0.5 ml, with an exposure time of 4 hours. The observation period was 48 hours. Results: OSHA score (0 and 48 hours) = 1.33 A defatting effect was noted. Rabbits/ Six New Zealand Two male and one female Not irritating The dose used was 0.5 ml, with an exposure of 24 hours. The observation period was 7 days. Results: OECD score (0, 24, 48 and 72 hours) = 2.23 OSHA score (0 and 48 hours) = 1.3 A defatting effect was noted. Eye irritation Rabbit Six animals Not irritating The undiluted test article was administered. Animals were observed at 1, 2, 3, 4 and 7 days following treatment. Eyes were scored according to Driaze All readings were negative. Material does not meet the Annex VI (R36) criteria for irritation. Rabbits/ Six New Zealand White Not irritating The dose used was 0.1 ml, with an observation period of 72 hours. Conjunctival redness and swelling were scored. There were no observed effects on the cornea or iris. After 72 hours all effects had disappeared. Rabbits/New Zealand White One male and 2 females Not irritating The dose used was 0.1 ml, with an observation period of 7 days. By day 7 effects had disappeared. Sensitization – Guinea pig maximization test Guinea pig/Hartley Albino 3 per sex Not sensitising Two male and 2 female animals in the positive control group. There was no negative control group. The dose was 0.3 ml of undiluted test material applied for 24 hours every other day for 10 applications. After a two week rest period, the challenge was made using a 24-hour exposure.