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EC number: 701-200-7
CAS number: -
The inhalation toxicity of multiconstituent
aluminium potassium fluoride was studied in a sub-chronic (90-day) study
in Wistar rats. Groups of 10 male and 10 female rats were exposed to
target concentrations of 0 (control), 0.3, 1, or 3 mg/m3 for six hours a
day, 5 days a week during a period of 90 days, with a total of 62 - 63
exposure days. The rats were necropsied the day after the last exposure.
Satellite groups of 10 male and 10 female animais each, similarly
exposed to target concentrations of 0 or 3 mg/m3 of the test substance
were kept for an additional recovery period of 60 days. To examine the
toxicity of the test material clinical signs, ophthalmology, body
weights, food consumption, food conversion efficiency, haematology,
clinical chemistry, and urinalysis were used. In addition, a full
necropsy was performed and the respiratory tract was examined
The concentration levels used during the
90-day study were based on a previously performed 28-day study with a
total of 20 exposure days. The level of 1 mg/m3 was considered to be a
Minimal-Observed-Adverse-Effect Level (MOAEL). This was based on the
presence of typical alveolar macrophage accumulations with cellular
debris/material lying freely in the alveolar lumen, suggesting
impairment or insufficient clearance capacity of the alveolar
In the present study, the mean actual
concentrations of multiconsituent aluminium potassium fluoride in the
test atmospheres, based on gravimetrical analysis were 0.32, 1.21, and
3.08 mg/m3 , for the low, mid, and high concentration, respectively.
Mean Mass Median Aerodynamic Diameters (MMAD) were 2.2, 2.6 and 2.6 μm
with corresponding geometric standard deviations of 2.1, 2.1 and 2.0,
No treatment-related abnormalities were
observed. Two male and two female animals of the control group were
found dead during exposure on day 58 of the study most probably due to
hypothermia. Another similarly affected control male recovered within 3
days. No treatment-related changes in body weight gain were observed. No
treatment-related changes in food intake and food conversion efficiency
were observed. No treatment-related changes in red blood cell variables
in both absolute and relative numbers of neutrophils were observed in
females of the high concentration group at the end of the exposure
period, but a statistical significant degree was reached in absolute
number only. At the end of the recovery period, absolute and relative
neutrophil counts were still higher in females. The increase in the
percentage of neutrophils in these females was accompanied by a decrease
in the percentage of lymphocytes at that time.No
treatment-related changes in clinical chemistry were observed.
Absolute and relative
lung weights were higher in females of the high concentration at the end
of the exposure period; a statistical significant degree was observed in
absolute weight only. In males no such changes were seen. At the end of
the recovery period, no changes in lung weights were observed. Macroscopic
examination at necropsy did not reveal treatment-related changes.
Microscopic examination of the respiratory tract at the end of the
90-day exposure period revealed a concentration-related change in the
lungs consisting of typical alveolar macrophage accumulations in animals
of the mid and high concentration group. A tissue reaction appeared
absent. The macrophage accumulations persisted after a recovery period
of 60 days. The macrophages were somewhat smaller in size when compared
to those in animals of the high concentration group at the end of the
exposure period, but more conspicuous because their cytoplasm was darkly
stained. Despite the persistent presence of the macrophages, a tissue
reaction was still absent. The presence of the macrophages are
considered a physiological response to the exposure and therefore not
considered adverse as such. Therefore, 1.21 mg/m3 is considered a NOAEC
for local effects. The overall systemic NOAEC is >3.08 mg/m3.
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