Dermal Toxicity Study No. 1 (Budd, 1967) Species/strain: rabbit/albino Number/sex of animals: 2/sex Observation period: 28 days Method of administration: polyethylene wrap for 24 hours Clinical observations: moderate erythema on the skin of all four rabbits and severe oedema, particularly in the abdominal ulceration and inflammation in the most severely affected areas during the first 14 days after treatment; scar formation during the last 14 days Mortality: None Morphological findings: None Test method: as described in 16 CFR 1500.40 LD50: > 2 000 mg/kg Result: the notified chemical was of low acute dermal toxicity in rabbits and may be a severe skin irritant No. 2 (Heenehan et al., 1977a) Species/strain: rabbit/New Zealand White Number/sex of animals: 1/sex/dose group Observation period: 14 days Method of administration: occlusive dressing for 24 hours; test substance as an aqueous slurry at 200 mg/kg, 500 mg/kg and 2 000 mg/kg on abraded and non abraded skin Clinical observations: slight erythema was observed in one animal (500 mg/kg) and severe erythema was observed in the remaining five animals following dressing removal; slight oedema was observed in one animal (500 mg/kg), moderate oedema was observed in 4 animals and severe oedema in one animal (2 000 mg/kg); lethargy was noted in one animal during the first 24 hours following compound
LD50: > 8 g/kg Result: the test substance was of low dermal toxicity in rabbits Inhalation Toxicity No data provided. Skin Irritation Study No. 1 (Stachowiak & Baker, 1975) Species/strain: rabbit/New Zealand White Number/sex of animals: 6/unspecified Observation period: 72 hours Method of administration: 0.5 g of dry powder was applied under occlusive dressing for 4 hours Test method: Department of Transportation, Hazardous Materials Regulations (Department of Transportation, 1972) Result: third degree chemical burns were observed in all animals up to 72 hours the notified chemical was corrosive to the skin in rabbits Study No. 2 (Edmonds, 1967b) Species/strain: rabbit/albino Number/sex of animals: 3/sex Observation period: 72 hours Method of administration: 0.5 mL of the test material under a gauze patch for 24 hours on abraded and unabraded skin Test method: Unspecified Result: at 24 hours erythema and oedema were slight in all animals; at 72 hours no irritancy was detected; with abraded skin, at 24 hours 3 animals exhibited moderate erythema and 3 animals slight erythema but
Test method: 16 CFR 1500.41 Result: severe erythema was observed in all animals at 24 and 72 hours post-treatment; slight oedema was observed in 3 animals at 24 hours and 5 animals at 72 hours with the remaining animals exhibiting moderate oedema the notified chemical was a severe skin irritant in rabbits Study No. 5 (Gabriel, undated) Species/strain: rabbit/Albino Number/sex of animals: 6 Observation period: 72 Method of administration: 0.5 g of the test substance was applied under an occluded gauze patch for 24 hours Test method: Federal Hazardous Substances Amendment (US Government, 1964) Result: severe erythema was observed in all animals at 24 and 72 hours post-treatment the notified chemical was a severe skin irritant in rabbits Study No. 6 (Chang, 1981) Species/strain: rabbit/New Zealand Number/sex of animals: 6/test: 3 tests done Observation period: up to 48 Method of administration: in all tests 0.5 g of the test substance was applied under a patch for 4 hours; the patches were: 25 cm2 gauze patch under occlusive plastic sheet; a “Coverlet Eye Occlusor” (6 in2); 25 cm2 gauze patch loosely wrapped in a plastic sheet Test method: Unspecified Result: 1. at 4 hours, blanching and oedema in two rabbits, 4
rabbits normal; by 48 hours, necrosis in one rabbit and a blanched area surrounded by erythema in another rabbit; it was concluded that the test substance was corrosive in two rabbits; observations up to 48 hours revealed necrosis at the test site in all rabbits; observations up to 48 revealed no necrosis at the test site and barely perceptible to slight erythema and oedema in 5 rabbits and no reaction in another rabbit it was concluded that, the “Coverlet” adhesive pad, the test material was held tightly against the skin with possibly enhanced humidity leading to hydrolysis and the production of acetic acid which is corrosive Eye Irritation No. 1 (Edmonds, 1967a) Species/strain: rabbit/New Zealand White Number/sex of animals: 3/sex Observation period: 72 hours Method of administration: 0.1 g of the test substance into the right eye of each animal Test method: similar to OECD guidelines (Organisation for Economic Co-operation and Development, 1995-1996) Result: severe corneal, iridal and conjunctival effects were seen in all animals at all time points the notified chemical was a severe eye irritant in rabbits Study No. 2 (Budd, 1967) Species/strain: rabbit/albino Number/sex of animals: 3/sex for each of two tests, one with a 15 minute washout after 5 minutes Observation period: 72 Method of administration: 0.1 g of the test substance into the right eye of each animal