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EC number: 628-448-8 | CAS number: 34451-26-8
Two in vivo studies are available performed according to OECD 423 guideline and GLP principles.
The acute oral toxicity of NS-1000 was determined in accordance with OECD 423 guideline and according to GLP principles.
NS-1000 was administered to male and female mice by a single dose of 2000, 300 and 50 mg/kg bodyweight. Four of 6 males and 4/6 females at 2000 mg/kg bw and 1/6 males and 3/3 females at 300 mg/kg bw were either found dead or euthanized in extremis. All early deaths were observed between study days 2 through 8. All other animals survived to the scheduled necropsy (study day 14).
Clinical observations limited to the early death animals in the 2000 mg/kg bw group consisted of head tilt, tremors, and wet red and clear material around the mouth (post mortem). Cool body or extremities and ataxia were limited to the 300 and 2000 mg/kg bw group early death animals. Dermal atonia was limited to the 300 mg/kg bw early death animals. Other clinical observations noted at 300 and 2000 mg/kg bw, including in animals that survived to study termination, consisted of hypoactivity, decreased defecation, poor body condition (water bottle added), and partial closure of the eye(s). For the animals that survived to the scheduled necropsy, a blue abdomen was observed in the 300 mg/kg bw group males and body weight loss was noted in the 50, 300, and 2000 mg/kg bw groups. Most of the aforementioned clinical observations occurred between study days 1 and 8.
Three of the 5 surviving males in the 300 mg/kg bw group and both surviving males in the 2000 mg/kg bw group lost weight during the first week after dosing (study days 0 to 7) but then gained weight during the second week after dosing (study days 7 to 14). All surviving males surpassed their study day 0 body weight at the end of the 14-day observation period with the exception of 2000 mg/kg bw group one male. The 6 surviving females in the 50 mg/kg bw group lost a small amount of weight during the first or second week after dosing. Both surviving females in the 2000 mg/kg bw group lost weight during the first week after dosing but then gained weight during the second week after dosing (study days 7 to 14). Three of the surviving females in the 50 mg/kg bw group and both surviving females in the 2000 mg/kg bw group surpassed their study day 0 body weight at the end of the 14-day observation period.
Macroscopic findings for early death animals included a small thymus for 3 males and 2 females at 2000 mg/kg bw, a small spleen for 2 males and 2 females at 2000 mg/kg bw, and dark red discoloration of the lungs for 2 females at 300 mg/kg bw and 1 male at 2000 mg/kg bw. In addition, 1 female that was euthanized in extremis at 300 mg/kg bw had dark red areas in the glandular portion of the stomach and dark red contents in the duodenum and jejunum. One female at 300 mg/kg bw that died had dark red contents in the stomach. There were no gross findings for the animals that survived to the scheduled necropsy (study day 14).
The oral LD50 of NS-1000 as a single dose in male mice is greater than 300 mg/kg bw but less than 2000 mg/kg bw (Category 4). The oral LD50 of NS-1000 as a single dose in female mice is greater than 50 mg/kg bw but less than 300 mg/kg bw (Category 3).
Based on the effects observed in the female mice, NS-1000 shall be classified for acute oral toxicity Category 3 and shall be labelled with H301: Toxic if swallowed, according to Regulation (EC) No 1272/2008 on classification, labelling and packaging.
Acute oral rat:
NS-1000 was administered to three male and three female rats by a single dose of 2000 mg/kg bodyweight. All animals survived to the scheduled necropsy. Clinical observations were limited to dried and/or wet yellow material on the urogenital and/or anogenital areas for 1 female on 1 to 3 occasions during study days 1 to 4. There were no test substance-related body weight changes noted during the study. All rats gained weight at each interval with the exception of 1 female that had a slight (8 grams) body weight loss for study days 0 to 7. This isolated body weight loss was not attributed to NS-1000 administration. There were no macroscopic findings at the scheduled necropsy. Based on the results of this study, the estimated LD50 of NS-3000 was greater than 2000 mg/kg body weight and the substance does not need to be classified for acute oral toxicity according to Regulation (EC) No 1272/2008 on classification, labelling and packaging.
Acute oral mouse:
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