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EC number: 252-044-7
CAS number: 34455-00-0
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.
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.
Based on the results of the studies, FBSEE diol does not meet the CLP
classification criteria for acute toxicity.
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