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Description of key information

Two acute toxicity studies were conducted on FBSEE diol. The results of the studies were:

- The acute oral LD50 is greater than 2,000 mg/kg when tested according to OECD 423 (2001).

- The acute dermal LD50 is greater than 2,000 mg/kg when tested according to OECD 402.

Key value for chemical safety assessment

Additional information

The acute oral toxicity potential of the test article was evaluated in Wistar rats. The study was performed in compliance with OECD GLP (1997). The test method was based OECD 423 (2001). The test material was dissolved in propylene glycol to achieve the appropriate dose. Fasted female rats (n = 3) received a single 2000 mg/kg oral dose of the test article via gavage at a volume of 10 mL/kg. As all animals survived that dosing, another group of 3 female rats were dosed in a similar manner. Observations for mortality were made twice daily and body weights were collected on Days 1, 8, and 15. Observations for clinical signs of toxicity were made daily. Necropsy was performed on all animals at termination. All animals survived for the duration of the study. Hunched/flat posture (3 animals, and piloerection (4 animals) was observed through Day 2. Uncoordinated movements, lethargy and slow breathing were noted in all animals on the day of exposure at up to 4 hours postdose. The body weight gains were considered normal. No gross abnormalities were observed at necropsy.  Based on the results of the test, the oral LD50 of the test article is greater than 2000 mg/kg bw in rats.

 

The dermal lethality potential of the test article was evaluated in male and female Sprague Dawley rats. The study was performed in compliance with OECD GLP regulations. The test was performed according to OECD 402. Rats (5 males and 5 females) received a 24-hour dermal exposure of 2000 mg/kg. The test article was moistened with distilled water on porous gauze and applied to the dorsal region (clipped, 10% body surface) of each rat. The exposure site was wrapped with porous dressing and porous non-irritating tape (semi-occlusive). After 24 hours the gauze was removed and any remaining test article was removed by washing with distilled water. All rats survived the study. Clinical observations included chromorhinorrhea and wetness of the anogenital area. Immediately following unwrapping, erythema was absent to very slight and edema was absent. By Day 14, erythema and edema were absent. Based on the results of the study, the rat dermal LD50 of the test article is greater than 2,000 mg/kg body weight.

Justification for classification or non-classification

Based on the results of the studies, FBSEE diol does not meet the CLP classification criteria for acute toxicity.