LD50: > 460 mg/kg Result: the test material (23% notified chemical) was of low dermal toxicity in rabbits. Inhalation Toxicity No studies were available. Skin Irritation (44% Notified Chemical) (Glaza, 1996f) Species/strain: rabbit/Hra: (NZW)SPF Number/sex of animals: 2 males and 1 female Observation period: 72 hours Method of administration: dermal application (0.5 mL) to the intact skin on each animal’s back; covered with a semiocclusive dressing for 4 hours Test method: similar to OECD TG 404 (Organisation for Economic Co-operation and Development, 1995- 1996) Draize scores: Draize scores at 24, 48 and 72 hours after application were zero for all animals Result: the test material (44% notified chemical) was not irritating to the skin of rabbits Skin Irritation (23% Notified Chemical) (Shapiro, 1989e) Species/strain: rabbit/New Zealand Albino Number/sex of animals: 3/sex Observation period: not stated Method of administration: dermal application (0.5 mL) to both intact and abraded skin covered with an occlusive dressing for 24 hours
Method of administration: each rabbit received 0.1 mL undiluted material placed into the everted lower lid of the right eye, with the left eye serving as the untreated control Draize scores (Draize, 1959) of eyes: Time after instillation Animal 1 day 2 days 3 days 4 days 7 days 14 days 21 days 1 see Attachment 1 for Draize scales o opacity a area r redness c chemosis d discharge Sodium fluorescein examination: sodium fluorescein examination results showed 1 rabbit became negative after 48 hours and other 2 became negative after day 7 Test method: OECD TG 405 (Organisation for Economic Co- operation and Development, 1995-1996) Comments: The test material caused broad corneal opacity, lesions of the iris and moderate to severe irritation of the conjunctivae. Irritation was still present in two animals at the end of the observation period (21 days) Result: the test material (44% notified chemical) caused severe damage to the eyes of rabbits
Eye Irritation (23% Notified Chemical) (Shapiro, 1989f) Species/strain: rabbit/New Zealand Albino Number/sex of animals: 2 males and 4 females Observation period: not stated Method of administration: each rabbit received 0.1 mL undiluted material placed into the right eye, with the left eye serving as the untreated control Draize scores (Draize, 1959) of eyes: 1 see Attachment 1 for Draize scales O opacity a area r redness c chemosis d discharge
Test method: Product Safety Labs protocol Result: the 23% notified chemical caused severe damage to the eyes of rabbits Eye Irritation (5% Notified Chemical) (Shapiro, 1989g) Species/strain: rabbit/New Zealand Albino Number/sex of animals: 6 Observation period: not stated Method of administration: each rabbit received 0.1 mL of 5% notified chemical in into conjunctival sac of the right eye, with the left eye serving as the untreated control
Repeated Dose Toxicity on Material Containing 23% Notified Chemical (Thomford, 1996) Species/strain: rat/Cr1: CD(SD)BR Number/sex of animals: 5/sex/group Method of administration: oral (gavage) duration:: 0, 6.9, 69 or 460 mg/kg/day for 4 weeks (vehicle: water) Clinical observations: all animals survived, excessive salivation was immediately after dosing for all high dose animals, from day 13 and continuing throughout treatment Clinical chemistry/Haematology slight to moderate increase in AST and ALT in high dose rats, slight increase in absolute neutrophil count in high dose males, and slight decrease in glucose and total protein and moderate increase in inorganic phosphorus in high dose females; these changes could not be correlated with histopathology Histopathology: no histopathological changes were associated with the test substance; an increase of adrenal gland weight in high dose males could not be related to pathological changes Test method: similar to OECD TG 407 (Organisation for Economic Co-operation and Development, 1995- 1996) Result: Based on the slight increase in adrenal weights and slight changes in clinical chemistry parameters at the high dose, the no observable effect level (NOEL) for the test material (23% notified chemical) is 69 mg/kg/day
Genotoxicity Salmonella typhimurium Reverse Mutation Assay (23% Notified Chemical) (Shapiro, 1989a) Strains: S. typhimurium TA98 and TA1535 Concentration range: 0.05 – 1.0 g/plate with and without S-9 Test method: similar to OECD TG 471 (Organisation for Economic Co-operation and Development, 1995- 1996) Result: the test material (23% notified chemical) did not induce mutation in S. typhimurium strains TA98 and TA1535 in the absence or presence of metabolic activation Salmonella typhimurium Reverse Mutation Assay (23% Notified Chemical) (Ballantyne, 1996) Strains: S. typhimurium TA98, TA100, TA1535 and TA1537 Concentration experiment 1: 0.16, 0.8, 4, 20 and 100 g/plate without S-9, and 0.8, 4, 20, 100 and 500 g/plate with S-9; experiment 2: 3.125, 6.25, 12.5, 25 and 50 g/plate without S-9, and 12.5, 25, 50, 100 and 200 g/plate with S-9 Test method: similar to OECD TG 471 (Organisation for Economic Co-operation and Development, 1995- 1996) Result: the test material (23% notified chemical) did not induce mutation in four strains of S. typhimurium in the absence or presence of metabolic activation