Potassium 1,1,2,2,3,3,4,4,4-nonafluorobutane-1-sulphonate

Endpoint summary

Description of key information

Two acute oral toxicity and two acute dermal toxicity studies were conducted on PFBS K+.

 

The rat acute oral LD₅₀is greater than 2000 mg/kg when tested according to OECD 401.

 

The rat acute oral LD₅₀is greater than 2000 mg/kg when tested according to OECD 423.

 

The rat acute dermal LD₅₀is greater than 2000 mg/kg when tested according to OECD 402.

 

The rat acute dermal LD₅₀is greater than 2000 mg/kg when tested according to OECD 402.

Additional information

Acute Oral Lethality:

The acute oral lethality of the test article was determined in rats. Crl:CD®(SD) IGS BR stock albino rats (5/sex/dose) received 2000 mg/kg test article dissolved in carboxymethylcellulose via oral gavage. Observations for mortality and morbundity (twice daily), body weights (pretest and day 1, 8, and 15), clinical signs (predose and approximately hourly for 4 hours postdose on day 1 and daily thereafter for at least 14 days), and macroscopic examination (at necropsy). At 2000 mg/kg all animals survived. Clinical observations included male localized alopecia, urine-stained abdominal fur, and one female had liquid feces at three and four hours post dose. These clinical observations did not appear to be related to the test material exposure. Mean body weights increased in males (114.1 g) and females (49.4 g) between study day 1 and day 15, however, no record of body weight loss occurred during the study in either sex suggesting no adverse effect of a single 2000 mg/kg test article dose. On study day 15 all animals (non-fasted) were euthanized and necropsied. Necropsy failed to reveal any adverse findings with the exception of dilation of the right kidney in one male and one female, however, this effect is usually induced by hydronephritis of the kidney and is not uncommon in rats; these findings were not considered related to the test material. Based on the results of the study, the rat oral LD50 of the test article is >2000 mg/kg.

 

The acute oral lethality of the test article was determined in rats using the acute toxic class method. Female Wistar rats (n = 3) received a starting dose of 2000 mg/kg test material formulated in ethanol/solutol HS 15/tap water (10/40/50%). Observations for mortality (several times on day of application and at least once daily for the remaining observation period), body weights (pretest and day 1, 7, and once weekly through observation period), clinical signs (several times on day of application and at least once daily for the remaining observation period), and macroscopic examination (at necropsy). At 2000 mg/kg bw all animals survival. No clinical signs were observed and no findings were observed at necropsy. No further doses were used.

Based on the results of the study, the rat oral LD50 of the test article is >2000 mg/kg bw.

 

Acute Dermal Lethality:

The acute dermal lethality of the test article was determined in rats. Sprague-Dawley rats (5/sex/dose) received 2000 mg/kg test article mixed with enough carboxymethylcellulose in water to for form a paste to the dorsal area of the trunk (approximately 10% of the body surface area). Observations for mortality and morbundity (recorded twice daily), body weights (pretest and day 1, 8, and 15), clinical signs (predose and approximately hourly for four hours postdose on study day 1 and once daily thereafter for at least 14 days), and macroscopic examination (at necropsy). At 2000 mg/kg all animals survived; one male rat died due to procedural complications and was replaced. Clinical observations included red material around the eyes, nose and mouth, however, these were not present after day 2 of the study and were not considered to be related to test material exposure. No adverse effects on body weights or body weight changes were seen. When compared to Study Day 1, Study Days 8 and 15 male mean body weights were increased 17% and 40%, respectively. Likewise, female mean body weights were increased 8% and 19%, respectively. On Study Days 1 through 15, male mean body weight change was increased 96.6g while bodyweight change in the females was increased 31.6g. No adverse gross findings were recorded for either sex with the exception of one male rat (previously stated) which died due to procedural complications. Based on the results of the study, the rat dermal LD50 of the test article is >2000 mg/kg.

 

The acute dermal lethality of the test article was determined in rats. Wistar rats (5/sex/dose) received 2000 mg/kg bw test material on the back/flanks (approximately 10% of the body surface area). Observations for mortality (several times on day of application and at least once daily for the remaining observation period), body weights (pretest and day 1, 7, and once weekly through observation period), clinical signs (several times on day of application and at least once daily for the remaining observation period), and macroscopic examination (at necropsy). At 2000 mg/kg all animals survival. Local signs were observed in 2 female rats (#7 and #8), including: partial reddening (day 4-5) and partial formation of scale (day 6 to 7) of the test area. No other signs were observed. There were no toxicological effects were observed on body weight or body weight development in males and females. No adverse gross findings were recorded for either sex. Based on the results of the study, the rat dermal LD50 of the test article is >2000 mg/kg.

 

Justification for classification or non-classification

The results for the test article do not meet the criteria for harmful of toxic by ingestion or dermal exposure.