Registration Dossier

Administrative data

Description of key information

Two acute oral toxicity studies were conducted on C4 Amin.  The result of the studies were:
- The rat oral LD50 is greater than 200 mg/kg and less than 2,000 mg/kg when tested according to OECD 423.
- The rat oral LD50 is 540 mg/kg when tested according to a protocol developed by Litchfield and Wilcoxon.

Key value for chemical safety assessment

Additional information

The acute oral toxicity potential of the test article was evaluated in male and female rats. The test was not intended to comply with GLP guidelines. The test method was based on EEC Guidelines B.1 (1996) and OECD 423 (1996). Male and female rats (Wistar, 3/sex/group) received 200 mg/kg test article suspended in bi-distilled water via single oral gavage at a dose volume of 10 mL/kg. Three additional female rats received 2,000 mg/kg test article in the same manner. Rats were observed at 1, 2, 3 and 5 hours post-dose, and once daily for 14 days for clinical signs of toxicity. Body weights were recorded on Day 1 (prior to administration) and on Days 8 and 15. All animals were examined via necropsy at termination. All animals (3 females) dosed at 2,000 mg/kg were found dead 5 or 7 hours after treatment. Ruffled fur, hunched posture, lateral recumbency, tremors and half closed lids were noted in the female rats dosed at 2000 mg/kg prior to death. The animals dosed at 200 mg/kg survived through the end of the observation period and had no abnormal clinical signs. Black-brown contents in the stomach, duodenum and jejunum were noted in all females dosed with 2000 mg/kg test article upon necropsy. All other animals were without macroscopic findings. The body weight gain of the animals in the 200 mg/kg group was within the range commonly recorded for this strain and age. Based on the results of the test, the oral LD50 of the test article is > 200 mg/kg body weight (LD0) and < 2,000 mg/kg body weight (LD100).

 

The acute oral toxicity potential of the test article (CASRN 74993-03-6, Clear colorless liquid, Purity: >95%, Density: 1 g/mL, Internal sample number A. Nr. 00267) was evaluated in male and female Wistar rats. The study information presented below is based on a report with limited data. The test was not conducted according to GLP guidelines. The test method was based on an acute toxicity protocol developed by Litchfield and Wilcoxon (1949). Male and female rats (5/sex/group) received 0.422, 0.51, 0.62, 0.75, or 0.91 mL/kg (422, 510, 622, 750, or 910 mg/kg) test article at a dose volume of 10 mL/kg. Animals were observed for 14 days post-dose for mortality and clinical signs.  At 370 mg/kg one male (1/5) died between Days 2 and 7. At 510 mg/kg, three males (3/5) died between Days 2 and 7. At 622 mg/kg, three males (3/5) and two females (2/5) died between Days 2 and 7. At 750 mg/kg, four males (4/5) and three females (3/5) died during the 14 Day observation period. At 910 mg/kg, all males (5/5) and four females (4/5) died during the 14 day observation period. All other animals survived to the end of the observation period (Day 14). The study report provided limited details on clinical signs of toxicity. The clinical signs were summarized and were not presented on a group or animal basis. Based on the available information, observed clinical signs included cowered position, piloerection, ptosis, incrustation of the nose and eyes, apathy, and loss of weight. The report indicates that clinical signs decreased after Study Day 4; however, it did not indicate when or if clinical signs fully resolved through Study Day 14. Based on the results of the study, the oral LD50 of the test article is 622 mg/kg body weight.

Justification for classification or non-classification

The test article meets the CLP classification criteria for Acute Toxicity Category 4.