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

Endpoint summary

Description of key information

Two in vivo eye irritation and in vivo skin irritation studies have been conducted on PFBS K+.

 

Eye Irritation: Corrosive when tested according to OECD 405.

 

Eye Irritation: Corrosive when tested according to OECD 405 (1987).

 

Skin Irritation: Non-irritating when tested according to OECD 404.

 

Skin Irritation: Non-irritating when tested according to OECD 404 (1992).

Additional information

Eye Irritation:

 

The primary ocular irritation/corrosion potential of the test article was evaluated in three female New Zealand White rabbits. The study was based on OECD 405 (no year reported) and was certified GLP. Approximately 80 mg of test material was instilled unchanged to the conjunctival sac of the left eye of each rabbit by gently pulling the lower eyelid away from the eye; the right eye of each animal served as a control. Both eyes were held closed for approximately 2 seconds after administration to ensure adequate distribution of the test material. The treated eye of each rabbit was examined for irritation of the cornea, iris and conjunctiva at 1, 24, 48 and 72 hours postdose and daily on Days 5-21 using the Draize technique. After the examination at 24 hours postdose, both eyes of each rabbit were rinsed with approximately 5 mL of 0.9% saline. The Primary Irritation Index (PII) was calculated. Corneal opacity was observed in all animals at 1 hour postdose (scores: 1, n=2; 2, n=1) and cleared in 2/3 animals by 48 hours and 7 days postdose, respectively. The individual mean scores (24-72 hours) for corneal opacity were 0.33, 2.0, and 1.67. Iritis was observed in all animals at 1 hour postdose (scores: 1, n=1; 2, n=2) and cleared in 2/3 animals by Days 5 and 6, respectively. All individual mean scores (24-72 hours) for iritis were 1.0. Conjunctival redness was observed in all animals at 1 hour postdose (all scores: 2) and resolved in 2/3 animals by Day 10. The individual mean scores (24-72 hours) for conjunctival redness were 1.67, 2.0, and 2.0. Conjunctival chemosis was observed in all animals at 1 hour postdose (scores: 1, 2, and 4) and cleared in 2/3 animals by Days 7 and 8, respectively. The individual mean scores (24-72 hours) for conjunctival chemosis were 2.0, 2.0, and 2.67. Conjunctival discharge was observed in all animals at 1-72 hours (all scores: 3), Days 5-6 (scores: 2, n=2; 3, n=1), Days 7-12 (all scores: 1), Day 13 (scores: 1, n=2; 2, n=1), Days 14-17 (scores: 1, n=2; 3, n=1), and Day 18 (all scores: 1). Discharge resolved in 2/3 animals by Days 19 and 21, respectively. Ocular irritation still persisted in 1/3 animals on Day 21 (corneal opacity: 4, iritis: 2, redness: 2, chemosis: 3, discharge: 1). The highest mean PII was 36.33/110 at 1 and 48 hours postdose. Occular effects in one animal did not fully reverse by 21 days. Based on the results of the study, the test article is corrosive to the eyes of rabbits.

 

The primary ocular irritation/corrosion potential of the test article was evaluated in three male Himalayan rabbits. The study was based on OECD 405 (1987) and was certified GLP. Approximately 100 mg of test material was instilled unchanged to the conjunctival sac of the right eye of each rabbit by gently pulling the lower eyelid away from the eye; the left eye of each animal served as a control. The eye was held closed for approximately 1 seconds after administration to ensure adequate distribution of the test material. Corneal opacity, iris irritation, conjunctival redness, and conjunctival chemosis were scored at 1, 24, 48, and 72 hours post instillation and daily on days 4-21. Corneal opacity was observed in all animals: animal #1 1 hour to 10 days after instillation (grade 2), from day 11 to day 21 no evaluation was possible due to swelling; animal #2 1 hour to 21 days (grade 2) after instillation; and animal #3 1 hour and 24 hours (grade 2) and 48 hours to 11 days (grade 1) after instillation. Corneal staining was seen in animal #1 (whole surface) and animal #2 and #3 (1/2 surface). The fluorescein tests performed after 14 and 21 days revealed corneal staining in animal #2 (1/2 surface); evaluation of animal #1 was not possible due to swelling. Irritation of the iris (grade 1) was seen in all animals 1 hour to 72 hours post instillation, in animal #1 until day 10, and animal #2 until day 21 of instillation. Animal #1 was not able to be evaluated from day 11 to 21 due to swelling. Conjunctival redness was observed in all animals: animal #1 1 hour (grade 1) and 48 hours to 21 days (grade 2) after instillation; animal #2 1 hour and 72 hours to 21 days (grade 1) after instillation; and animal #3 1 hour to 10 days (grade 1) after instillation. Conjunctival chemosis was observed in all animals: animal #1 1 hour (grade 1), 48 hours to 10 days (grade 2), and 11 to 21 days (grade 4) after instillation; animal #2 1 hour and 48 hours to 10 days (grade 1) and 11 to 21 days (grade 2) after instillation; and animal #3 1 hour to 8 days (grade 1) after instillation. Additionally, white deposits in the conjunctival sac were observed in animal #1 (48 hours to 21 days), animal #2 (48 hours to 10 days and 14 to 21 days), and animal #3 (7 to 12 and 14 to 17 days) after instillation. Loss of hair on the upper and lower lid was observed in animal #1 (48 hours to 21 days), animal #2 (7 to 21 days), and animal #3 (9 to 18 days) after instillation. Ocular effects in two animals did not fully reverse by 21 days. Based on the results of the study, the test article is corrosive to the eye.

 

Skin Irritation:

 

The primary skin irritation/corrosion potential of the test article was evaluated in New Zealand White rabbits. This study was performed in accordance with OECD GLP (1981) and US FDA GLP 21 CFR 58. The study design was based on OECD 404 (year not reported). The hair was clipped from the dorsal skin of three female rabbits. The test material (500 mg T-7458 moistened with 1% carboxymethylcellulose in deionized water) was placed under gauze on the back of each animal and secured with non-irritating tape for a 4-hour exposure. Residual test material was removed with warm tap water and gauze. Observations for skin irritation (erythema and edema) were recorded at time of patch removal and at 24, 48 and 72 hours after unwrapping. The Primary Irritation Index (PII) was calculated. There were no abnormal clinical signs or changes in body weight. All erythema and edema scores were 0 throughout the study. The PII was 0.0/8.0. Based on the results of this study, the test article is not a skin irritant.

 

The primary skin irritation/corrosion potential of the test article was tested in male Himalayan rabbits. This study was performed in accordance with GLP (1997). The study design was based on OECD 404 (1992). The hair was shaved from the skin of three male rabbits. The test material (500 mg moistened with water) was placed under gauze and secured with non-irritating tape for a 4-hour exposure. Observations for skin irritation (erythema, edema, and eschar formation) were recorded at 60 minutes and at 24, 48 and 72 hours after patch removal. None of the three rabbits exposed for 4 hours to 500 mg test article showed any substance-related erythema, edema, or eschar formation at any time point. Based on the results of the study, the test article is not a skin irritant.

Justification for classification or non-classification

PFBS K+ meets the CLP criteria for classification as Eye Dam. 1 and the GHS criteria for classification for eye irritation/corrosion Category 1 (Serious Eye Damage).

 

PFBS K+ does not meet the CLP or GHS criteria for classification as a skin irritant.