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Diss Factsheets

Administrative data

Description of key information

An acute oral toxicity study was conducted on Laurylimidazole.  The result of the study was: 
The rat oral LD50 is 641 mg/kg when tested according to ANSI/ADA Doc No. 41A.

Key value for chemical safety assessment

Additional information

The acute oral toxicity potential of the test article (yellow liquid, purity 99% CASRN 4303-67-7, batch 0001) was tested in male and female CFY Sprague Dawley rats. The experimental procedure was based on ANSI/ADA Document number 41a 1982. The test article was administered as received via oral gavage. Rats (5/sex/group) received 400, 500, 640, or 1000 mg/kg test article. Clinical observations were recorded at 0.5, 1, 2, 3, 4, 5, and 6 hours after dosing (Day 1) and then at least once daily through Day 15. Body weights were recorded on Day 1, 4, 8, 15 and on the day of death. Surviving animals on Day 15 were euthanatized and received macroscopic necropsy examination. Animal(s) died in the 500 mg/kg (1/5 females), 640 mg/kg (2/5 males and 5/5 females), and 1000 mg/kg (4/5 males, 5/5 females) treated groups from Day 2 to Day 5. Animals that survived to Day 6 survived until the end of the study on Day 15. Animals that died prematurely had congestion of the stomach and pallor of the liver, kidneys, and/or spleen. Body weight losses were recorded for all rats found dead. Piloerection and increased salivation were observed in all rats. Hunched posture was observed in all animals except one male and one female of the 1000 mg/kg group. Clinical signs with dose dependent increases in incidence included: decreased respiratory rate, ptosis, pallor of the extremities, diarrhea, increased lachrymation, and prostration. Lethargy and abnormal gait (waddling) were observed in 3-5 animals/sex in the 400, 640, and 1000 mg/kg dose groups and only 1 female in the 500 mg/kg group. Body weight losses or decreased gains were recorded among surviving male rats of all groups on Day 4 and among surviving female rats on Days 4 and 8. All surviving rats achieved anticipated body weight gains during the second week of the study with the exclusion of one female rat that had slightly decreased gain on Day 15. Terminal necropsies were normal. The oral LD50 with a 95% confidence interval was calculated using probit analysis by a log transformation of the dose relative to percent mortality. Based on the results of this study (10% mortality at 500 mg/kg and increasing up to 90% mortality at 1000 mg/kg), the rat oral LD50 is 641 mg/kg with 95% confidence limits of 558 to 759 mg/kg.

Justification for classification or non-classification

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