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EC number: 264-261-4 | CAS number: 63469-23-8
Acute toxicity - oral: A K2 key study is available (Auletta, 1979a): based on this study, the oral LD50 for male/female rats was estimated to be 2200 mg/kg body weight. The test was performed according to a method equivalent to OECD Guideline 401.In addition, a K3 supporting study is available (van Huygevoort, 2002): based on this study, the oral LD50 for female rats was considered to exceed 2000 mg/kg body weight. Acute toxicity - inhalation: In accordance with the specific rules for adaptation from column 1 (REACH Annex VII and VIII), no acute toxicity study needs to be conducted as the substance is classified as corrosive to the skin. Moreover, reliable data via two other routes of administration is available.Acute toxicity - dermal: For the dermal route, a K2 key study is available (Auletta, 1979b): based on this study, the dermal LD50 for male/female rabbits was estimated to be 3300 mg/kg.
Acute toxicity: oral
Auletta (1979a) investigated the acute oral toxicity of 1000, 1400, 2000, 2800 and 4000 mg/kg in 5 male/female Sprague-Dawley albino rats. After 14 days of observation following mortalities were observed: at 1000 mg/kg 1/10 animals died, 1400 mg/kg 0/10 animals died, 2000 mg/kg 2/10 animals died, 2800 mg/kg 9/10 animals died, 4000 mg/kg 10/10 animals died. Piloerection was noted at all levels throughout the observation period in the majority of the surviving animals. Motor activity decrease was evident at all levels most notably within twenty-four hours following test material administration. Also noted within the twenty-four hour period following intubation were red nasal and oral discharges and respiratory rate decrease. These signs were evident mainly at the 1000, 1400 and 2000 mg/kg dose levels.
All surviving animals at all dose levels exhibited weight gains during the fourteen-day post-dose observation period. This study was selected as key study. In addition, a K3 supporting acute oral toxicity study was conducted in rats and the acute oral LD50 observed in this study was observed to be > 2000 mg/kg (van Huygevoort, 2002).
Acute toxicity: dermal
For the dermal route, a K2 key study is available (Auletta, 1979b). New Zealand White rabbits were exposed to 2000, 2800, 4000 and 5600 mg/kg of the substance. After 14 days of observation following mortalities were observed: at 2000 mg/kg: 0/4 animals died; at 2800 mg/kg: 2/4 animals died; at 4000 mg/kg: 2/4 animals died; at 5600 mg/kg: 4/4 animals died. At the twenty-four hour dermal observation the majority of the animals at all levels exhibited severe erythema accompanied by necrotic skin and moderate edema. Physical signs noted in the majority of animals at all dose levels during the fourteen-day post-dose observation period were clear nasal discharge, piloerection and motor activity decrease. During the two week observation period the majority of the surviving animals showed no change in weight or a slight weight gain. Based on this study, the dermal LD50 for male/female rabbits was estimated to be 3300 mg/kg.
Acute toxicity: inhalation
No acute inhalation toxicity study was performed.
Based on one K2 study (Auletta, 1979a), the oral LD50 for male/female rats was estimated to be 2200 mg/kg body weight. According to the criteria of the CLP Regulation, the substance does not have to be classified for acute oral toxicity as the LD50 value is > 2000 mg/kg bw.
Based on one K2 study (Auletta, 1979b), the dermal LD50 for male/female rabbits was estimated to be 3300 mg/kg body weight. According to the criteria of the CLP Regulation, the substance does not have to be classified for acute dermal toxicity as the LD50 value is > 2000 mg/kg bw.
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