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EC number: 200-929-3
CAS number: 76-05-1
after a four-hour inhalation exposure
Mortality (Number of dead animals/Number of animals)
Time of death
weight (in g) after a four-hour inhalation exposure (Mean of the body
weight of the 10 males/[TFA] for the measurement at day -3, 0 and 1 and
Mean of the body weight of the 5 animals/[TFA] for the measurement at
day 3, 7 and 14)
Day numbers relative to start date
250.05 ± 11.36
263.03 ± 12.45
261.99 ± 11.02
266.54 ± 9.06
287.20 ± 10.12
307.86 ± 10.73
249.36 ± 8.22
262.42 ± 8.56
258.53 ± 8.87
262.84 ± 12.59
279.12 ± 13.01
297.24 ± 13.66
251.28 ± 9.05
266.37 ± 10.01
262.92 ± 11.22
271.24 ± 12.43
290.28 ± 11.82
311.52 ± 15.43
251.56 ± 7.84
263.35 ± 9.99
261.90 ± 10.28
263.10 ± 5.32
281.30 ± 9.65
302.94 ± 10.63
extended acute inhalation toxicity study was performed similarly to the
OECD guideline No. 403, including three concentrations of exposure for
NOAEC determination, and relevant additional examinations including
broncho-alveolar lavage (BAL) analysis, upper respiratory tract
histopathology including the lung analysis, and histopathology of the
liver, the kidneys, the testis and the thymus. This study was conducted
in compliance with the GLP.
preliminary study, male and female Wistar rats (3
animals/sex/concentration) were exposed to vapours of TFA (0; 30 or 300
mg/m3) according to a nose only exposure. At 30 mg/m3,
no significant differences were observed in the evaluated parameters
(clinical signs, body weight, BAL) between controls and exposed animals,
males or females. Effects after BAL were observed in male and female
rats exposed to 300 mg/m3. Indeed, in male animals ALP was
increased which showed in the ANOVA as an interaction of the factor
sexe. The total protein dosage was increased in the highest tested
concentration (300 mg/m3). Cellular parameters showed an
increase in neutrophils in the broncho-alveolar lavage fluid of male
animals of group animal treated with 300 mg/m3reflected in
significant group and sex factors in the ANOVA (p<0.05), a tendency for
an interaction. No other parameters were affected. As male animals
seemed more sensitive to the effects of exposure to trifluoroacetic
acid, they were used for the main study. Based on these results, the
concentrations for the main study were chosen to be 30, 100 and 300 mg/m3.
Furthermore, it was assumed that at this highest concentration of 300
mg/m3, histopathological findings would be observed.
In the main
study, the exposure method was unchanged compared to the preliminary
study. Two groups of 5 males/concentration were therefore exposed to TFA
vapours at concentrations of 0; 30; 100 or 300 mg/m3for 4
hours. The animals of the first group/concentration were sacrificed and
necropsied one day after the end of the exposure, while the animals of
the second group/concentration were sacrificed after a 14-day
observation period. This second group was designed in order to study the
reversibility of the effects which would be observed at day 1.
signs were observed, body weight (at day 0, 1, 3, 7, and 14) was
measured, gross pathology (at the sacrifice or death of animal) and
histopathology were analysed. In addition a broncho-alveolar lavage was
performed on the animals of the both groups in order to analyse
biochemical parameters such as the total protein content, the alkaline
phosphatase (ALP), the lactate Deshydrogenase (LDH), the
N-acetylglucosaminidase (NAG) and the gamma-glutamyltransferase
(gamma-GT). Furthermore thetotal
white blood cellnumber
was determined in the BAL.
mortality nor clinical signs or effect on body weight gain were observed
at the tested concentrations during the study. The macroscopic
examination of the testes and the thymus performed both one day after
exposure and after the 14-day recovery period, could not establish any
treatment-related changes. All changes observed were common findings for
rats of this strain and age.
microscopic level, the examination revealed treatment-related
histopathological changes at the second and third levels of the rat
nasal cavity within the day following the end of exposure. The
histopathological lesions consisted of a very slight focal degeneration
of the respiratory epithelium lining the dorsal part of the septum. It
was considered as the consequence of irritating local effects of the TFA
vapours. This lesion was only observed at the highest tested
concentration (300 mg/m3) in 4/5 animals for the second level
of the nasal cavity and in 1/5 animal for the third level. Furthermore,
this irritating local effect was reversible as there was no irritation
of the nasal cavity (all levels considered) in the animals necropsied 14
days after treatment. The histopathological analyses revealed no effect
of TFA vapours on the trachea, larynx, lungs, kidneys, liver and testes.
Furthermore, no treatment-related differences were recorded between the
control group and the TFA exposed groups in any of the biochemical and
cellular parameters after the broncho-alveolar lavage on both day 1 and
14 recovery periods.
conclusion, TFA induced no mortality at the tested concentrations (up to
300 mg/m3). However, at the highest concentration, TFA
induced local irritation of the nasal cavity epithelium of the rats.
This effect is reversible since no irritation of the nasal cavity was
noted in the animals necropsied at the end of the observation period.
The NOAEC for local effects based on the nasal cavity epithelium
irritation is therefore 300 mg/m3.
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