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EC number: 200-929-3
CAS number: 76-05-1
Homogeneity and concentration checks of TFA
in the diet were within 86 to 108% of the nominal concentration, with
the exception of only one analysis out of eight at 16000 ppm (129%)
which was outside the in-house target range of 85 to 115% of the nominal
concentration. In isolation, this result was considered acceptable for
the study. Therefore homogeneity and concentration checks of TFA at
16000 ppm were considered to be acceptable. At 1600 and 160 ppm,
concentrations and/or homogeneity were within the in-house target range
and were therefore considered to be acceptable.
The mean achieved dosage intake of TFA per
group was as follows:
Mean achieved dietary intake of Sodium trifluoroacetate (TFA)
Diet concentration ppm
*Between brackets the corresponding TFA
levels are indicated.
In a GLP-compliant OECD Guideline 408 study,
the test substance sodium trifluoroacetate was administered continuously
via dietary administration to separate groups of Wistar rats
(10/sex/group) at concentrations of 160, 1600 and 16000 ppm (equating
approximately to 8.4, 82.3, 876 mg TFA/kg body weight/day in males and
10.1, 103.3, 1021 mg TFA/kg body weight/day in females), respectively
for at least 90 days. A similarly constituted group of 10 males and 10
females received untreated diet and acted as a control. No
toxicologically significant changes were noted in clinical appearance,
functional observations, food consumption and ophthalmoscopy. At
necropsy a reduction in mean body weight gain of 17% and 6% was observed
for males and females, respectively at 16000 ppm when compared to the
controls. Body weight parameters were not affected in either sex at 1600
ppm and at 160 ppm.
Clinical pathology determinations revealed
lower mean hemoglobin concentration in females. This slight change was
associated with a statistically significantly lower mean corpuscular
volume, mean corpuscular hemoglobin and hematocrit. In addition, mean
total bilirubin and glucose concentrations were markedly lower in both
sexes. Mean values for alkaline phosphatase, aspartate aminotransferase
and alanine aminotransferase activities were higher in males. At
urinalysis, higher ketone levels were noted in both sexes.
Microscopic examination revealed test item
related changes in the liver. In all males and most females at 16000
ppm, as well as in a proportion of males at 1600 ppm, a minimal to
moderate diffuse centrilobular to panlobular hepatocellular hypertrophy
with groundglass appearance of the hepatocellular cytoplasm was
observed. This change was associated with a loss of the periportal
hepatocellular vacuolation observed at 16000 ppm in both sexes and at
1600 ppm in males. The effect was dose-related and correlated with the
higher mean liver weight noted in these groups (up to +33% and +28%
relative to vehicle controls in males and females, respectively at the
highest dose level). There was also a higher incidence of hepatocellular
necrotic foci in males at 16000 ppm when compared to controls, which was
considered to be adverse.This finding was correlated with higher
individual values of aspartate aminotransferase and alanine
aminotransferase activities observed in clinical chemistry evaluation.
The dose level of 160 ppm of sodium
trifluoroacetate is considered to be a No Observed Adverse Effect Level
(NOAEL) in both sexes (equating approximately to 8.4 mg TFA/kg body
weight/day in males and 10.1 mg TFA/kg body weight/day in females).
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