animal; 100 % petrolatum was applied to the shaved right flank patches were secured to the torso with bandages for 24 hours and dermal reactions were scored at 24 and 48 hours (Days 22 and 23) after patch removal OECD TG 406; Magnusson and Kligman maximisation test Test method: approximately 15 min following the intradermal injections, Comment: all animals in the treated group had blue skin, eyes, and mucous membranes, as well as blue urine for approximately 3 hours post-injection; after the challenge dose, no dermal reactions were noted for the test animals; control animals responded appropriately the notified chemical was non-sensitising to the skin of Result: guinea pigs 9.2 Repeated Dose Toxicity (Gearhart & Faber, 1998) rat/Sprague-Dawley Species/strain: 5/sex/group Number/sex of animals: HAEL# 97-0042 Test Substance: gavage Method of administration: 1000, 300, 100 and 0 mg/kg/day for 29 days; vehicle corn duration: oil OECD TG 407 Test method: all animals survived to the termination of the study Mortality: Clinical observations: Blue discolouration of the was observed for all treated animals, with colour intensity being minor for the 1000 mg/kg/day groups, and minimal for the 300 and 100 mg/kg/day groups, beginning on Day 0 and continuing for the duration of the study. All treated animals had blue discolouration of the faeces from Day 1 through study termination except for one or two days for the 300 and 100 mg/kg/day groups. Systemic blue discolouration including the skin, eyes, mouth, and/or mucous membranes due to absorption of the test substance was observed for all treated groups following administration of the test substance. No toxicologically significant alterations were observed in the functional observational battery. On Day 14, 300 mg/kg/day males had a significantly higher incidence of
animal; 100 % petrolatum was applied to the shaved right flank patches were secured to the torso with bandages for 24 hours and dermal reactions were scored at 24 and 48 hours (Days 22 and 23) after patch removal Test method: OECD TG 406; Magnusson and Kligman maximisation test Comment: approximately 15 min following the intradermal injections, all animals in the treated group had blue skin, eyes, and mucous membranes, as well as blue urine for approximately 3 hours post-injection; after the challenge dose, no dermal reactions were noted for the test animals; control animals responded appropriately Result: the notified chemical was non-sensitising to the skin of guinea pigs 9.2 Repeated Dose Toxicity (Gearhart & Faber, 1998) Species/strain: rat/Sprague-Dawley Number/sex of animals: 5/sex/group Test Substance: HAEL# 97-0042 Method of administration: gavage duration: 1000, 300, 100 and 0 mg/kg/day for 29 days; vehicle corn oil Test method: OECD TG 407 Mortality: all animals survived to the termination of the study Clinical observations: Blue discolouration of the was observed for all treated animals, with colour intensity being minor for the 1000 mg/kg/day groups, and minimal for the 300 and 100 mg/kg/day groups, beginning on Day 0 and continuing for the duration of the study. All treated animals had blue discolouration of the faeces from Day 1 through study termination except for one or two days for the 300 and 100 mg/kg/day groups. Systemic blue discolouration including the skin, eyes, mouth, and/or mucous membranes due to absorption of the test substance was observed for all treated groups following administration of the test substance. No toxicologically significant alterations were observed in the functional observational battery. On Day 14, 300 mg/kg/day males had a significantly higher incidence of
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