Butanamine, N,N-dibutyl-, branched and linear, fluorinated

Endpoint summary

Description of key information

Oral LD50> 5000 mg/kg
Oral LD50>10000 mg/kg
Inhalation LC50>41 mg/l 
Inhalation LC50>17 mg/l
IP LD50>34.6 g/kg

Additional information

The five lethality studies conducted on FC40/43 all indicate very low potential for acute lethality. The inhalation study was conducted at a concentration close to saturation. The lack of acute toxicity by any route is consistent with members of the fluoroinert category. Members of the fluoroinert category are not reactive toward biological molecules and cannot undergo bioactivation by normal enzymatic processes due to their chemical properties.

 

In the first oral study, an acute oral toxicity study was conducted on the test article using rats. One group of ten albino rats (5 male 5 female) were fasted for 24 hours previous receiving the test article by oral gavage. All rats were dosed at 10 g/kg bw. Following administration the rats were allowed food and water ad libitum for a 14 day observation period after which necropsy was performed on the survivors. No mortality or abnormal pathological findings were observed. The test article has an acute oral LD50 of greater than 10 grams per kilogram body weight in rats.

 

In the second oral study, an acute oral toxicity screen with the test article was conducted using male and female albino rats ranging in body weight from 183 to 217 grams. The test article was administered by gastric intubation at a dosage level of 5000 mg/kg body weight with no mortalities noted. No untoward behavioral reactions occurred during the 14 day observation period and body weight gains were noted for all animals which survived the test period. Necropsies performed at termination of the study revealed no visible lesions. The approximate oral LD50 of the test article is greater than 5000 mg/kg in fasted male and female albino rats.

 

In the first inhalation study, fourteen health albino rats (7 male, 7 female) were exposed to a nominal concentration of the test article at 41 mg per liter of air in a 70 liter Liter Plexiglas chamber for a period of four hours. During exposure the animals were observed for mortality and pharmacotoxic signs. Upon removal from the chamber 2 males and 2 females were sacrificed. Sections of their lungs, spleen, liver and kidneys were taken and placed in 10% formalin. The lung tissues were processed for histological evaluation. The remaining ten rats were observed for a period of 2 weeks, weighed, sacrificed and grossly examined. Results show that there were no deaths in the study. Weight gains were normal. At necropsy no grossly observable lesions were noted. The lung tissues examined microscopically, were normal. The test article can be considered practically non-toxic by inhalation.

 

In the second inhalation study, an acute inhalation study was conducted on the test article utilizing albino rats, guinea pigs, and Swiss white mice. All animals were acclimated for seven days and were not fasted prior to exposure to the test article. Five groups of two rats each, five groups of two mice each and five groups of two guinea pigs each were employed in the study. The inhalation exposures were conducted in a multiple inhalation chamber designed for simultaneous exposure to atmospheres saturated and fractionally saturated with vapors of the test material at room temperature (26 degrees C). Each test was designed to run for four hours. At the end of the exposure periods, surviving animals were returned to their stock cages and observed for the succeeding 14 days. No untoward reactions were noted in any of the animals species tested at the vapor concentration employed (17.0 mg/L) as a result of a four hour inhalation exposure of the test article.

 

In the intraperitoneal study, undiluted test article was administered by injection into the peritoneal cavity to three groups consisting of four albino rats (2 male, 2 female) each. The dose groups were 15.4, 23.1, and 34.6 grams per kilogram body weight. The rats were observed for pharmacotoxic signs, weight gains and mortality. Results show that the test article elicited abnormal stance, hypoactivity, and muscular weakness at all doses within 2 hours of compound administration. Ruffled fur was also observed at the high dose level. There were no deaths in the study. Weight gains were normal. No lesions were observed at necropsy. The test article can be considered practically non-toxic by intraperitoneal injection.

Justification for classification or non-classification

None of the results meet the criteria for toxic or highly toxic.