Endpoint and Result Assessment Conclusion Rat, acute oral Low toxicity, LD50 > 2000 mg/kg bw Rabbit, acute dermal Low toxicity, LD50 > 9ml/kg bw Rat, acute inhalation Not determined Rabbit, skin irritation Moderately irritating Rabbit, eye irritation Non-irritating Guinea pig, skin sensitisation - Guinea pig No evidence of sensitisation. maximisation test by Magnusson and Kligman Rat, oral repeat dose toxicity - 28 days. NOEL > 200 mg/kg bw/day Genotoxicity Ames Test Non mutagenic – Genotoxicity in vitro Chinese hamster lung Non genotoxic – fibroblasts (V79 cells) Genotoxicity based on analogue data: Non mutagenic in – 7.1. toxicity oral – Notified chemical OECD TG 401 Acute Oral Toxicity Limit Test. – Species/Strain Rat/Wistar Vehicle Water Remarks Method No deviation from protocol – Administration by gavage (5 mL/kg) Group Number and Sex Dose Mortality of Animals mg/kg bw 1 5/male 2000 Nil 2 5/female 2000 Nil LD50 > 2000 mg/kg bw Signs of Toxicity No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. All animals showed body weight gain during the study period. Effects in Organs Macroscopic examination of all animals at the end of the study revealed no gross abnormalities. Remarks Results – The notified chemical is of low toxicity via the oral C.V. (1987) 7.2. Acute toxicity dermal – Notified chemical (Summary only provided) Not Species/Strain Rabbit/New Zealand White Vehicle Undiluted Type of dressing Remarks Method The test was conducted by exposing a large surface of the skin to 0 – (control), 5, 10 or 100% of the material in an amount of 9 ml/kg body weight of the rabbits during 24 hours. Each of the doses was applied to 2 male and 2 female rabbits. In each dose group one male and one female received material on intact skin, while the other male and female was treated on the superficially damaged skin. After exposure, the animals were observed for a period of 14 days. Body weights and intake of food and water were recorded. At day 14 blood samples were collected for
Endpoint and Result Assessment Conclusion Rat, acute oral Low toxicity, LD50 > 2000 mg/kg bw Rabbit, acute dermal Low toxicity, LD50 > 9ml/kg bw Rat, acute inhalation Not determined Rabbit, skin irritation Moderately irritating Rabbit, eye irritation Non-irritating Guinea pig, skin sensitisation - Guinea pig maximisation test by Magnusson and Kligman No evidence of sensitisation. Rat, oral repeat dose toxicity - 28 days. NOEL > 200 mg/kg bw/day Genotoxicity – Ames Test Non mutagenic Genotoxicity – in vitro Chinese hamster lung fibroblasts (V79 cells) Non genotoxic Genotoxicity – in based on analogue data: Non mutagenic 7.1. toxicity – oral Notified chemical OECD TG 401 Acute Oral Toxicity – Limit Test. Species/Strain Rat/Wistar Vehicle Water Remarks – Method No deviation from protocol Administration by gavage (5 mL/kg) Group Number and Sex of Animals Dose mg/kg bw Mortality 1 5/male 2000 Nil 2 5/female 2000 Nil LD50 > 2000 mg/kg bw Signs of Toxicity No mortalities occurred and no signs of systemic toxicity were observed during the 14-day observation period. All animals showed body weight gain during the study period. Effects in Organs Macroscopic examination of all animals at the end of the study revealed no gross abnormalities. Remarks – Results The notified chemical is of low toxicity via the oral C.V. (1987) 7.2. Acute toxicity – dermal Notified chemical (Summary only provided) Not Species/Strain Rabbit/New Zealand White Vehicle Undiluted Type of dressing Remarks – Method The test was conducted by exposing a large surface of the skin to 0 (control), 5, 10 or 100% of the material in an amount of 9 ml/kg body weight of the rabbits during 24 hours. Each of the doses was applied to 2 male and 2 female rabbits. In each dose group one male and one female received material on intact skin, while the other male and female was treated on the superficially damaged skin. After exposure, the animals were observed for a period of 14 days. Body weights and intake of food and water were recorded. At day 14 blood samples were collected for
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