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EC number: 701-200-7
CAS number: -
The most critical effects of the substance after repeated inhalation exposure were effects on the lungs. Based on the available studies the overall NOAEC for local effects is 1.21 mg/m3. The overall systemic NOAEC is >3.08 mg/m3.
toxicity of aerosols of aluminium potassium fluoride was studied in a
subacute (28-day) study in rats (performed according to OECD guideline
412 and under GLP). Exposure was to concentrations of 0 (control), 106,
300 or 603 mg/m3 (TNO, 1999a).
Local effects were
considered critical. A concentration-related statistically significant
increase in relative lung weight was observed in male and female rats of
all test groups. Absolute lung weights were statistically significantly
increased in males of the mid and high concentration group and in
females of all test groups.
changes were induced in the nasal passages, larynx, bifurcation and
lungs. These changes, listed below, were slightly more prominent in
males than in females.
- Degenerative and
proliferative changes in the olfactory and respiratory epithelium were
induced in the posterior part of the nasal passages of animals from all
- Degenerative and
proliferative lesions of epithelium covering the arythenoid projections
and epiglottis were found in the larynx of high concentration group
animals and of one low concentration group animal.
changes at the tip of the carina at the bifurcation were induced in high
concentration group animals.
- In the lungs,
alveolar macrophage accumulation was observed in animals of all test
groups, with signs of macrophage disintegration in animals of the high
concentration only.Inflammation as occasionally observed in controls was
enhanced in animals of the test groups and shifted from predominantly
lymphocytic in controls to a granulomatous reaction in animals of the
mid and high concentration group. Bronchial and bronchiolar epithelial
hypertrophy was observed mainly in high concentration group animals,
although a few low and mid concentration group animals were affected as
From the results of
this study, it was concluded that even at the lowest concentration
tested (100 mg/m3) histopathological changes were induced in the nose,
and in a few animals, in the lungs as well. The NOAEC is therefore below
inhalation toxicity of aerosols of aluminium potassium fluoride was
studied in a subacute (28-day) study in male rats. Groups of 6 male rats
were exposed to target concentrations of 0 (control), 1.00, 3.10, 10.3,
or 103.8 mg/m3 (TNO, 2003). The study was performed under GLP
and according to a protocol equivalent or similar to OECD guideline 412.
In line with the other subacute study, local effects were considered
statistically significant increases in absolute and relative lung weight
were observed in rats exposed to 3, 10 or 100 mg/m3.
Macroscopic examination at necropsy did not reveal treatment-related
histopathological changes in the nasal passages, larynx, and lungs were:
- Focal olfactory
epithelial necrosis was observed in all animals exposed to 100 mg/m3,
in one animal exposed to 10 mg/m3, and in one animal exposed
to 3 mg/m3. Focal vacuolation of the olfactory epithelium,
possibly a precursor of necrosis was observed in a few animals exposed
to 10 mg/m3, and in one animal exposed to 3 mg/m3.
Respiratory epithelial metaplasia was observed in all animals exposed to
100 mg/m3, goblet cell hyperplasia of the respiratory
epithelium was observed in a few animals exposed to 10 mg/m3.
No treatment-related lesions were observed in the anterior part of the
- Sqaumous metaplasia
of the larynx with an underlying granulomatous inflammation was seen in
animals exposed to 100 mg/m3.
- In the lungs,
treatment-associated lesions consisted of typical alveolar macrophage
accumulations, accompanied by cellular debris/material lying freely in
the alveolar lumen (all test groups), inflammation (3, 10 and 100 mg/m3
test groups) and bronchial/bronchiolar epithelium alterations (3, 10 and
100 mg/m3 test groups). In addition, the incidence of BALT
germinal centre development increased with the concentration.
It was concluded that
exposure to 3 mg/m3 and higher induced increased absolute and
relative lung weights, and histopathological changes in the nose and in
the lungs, including typical alveolar macrophage accumulations. Typical
alveolar macrophages, however, were also observed in animals exposed to
1 mg/m3. The additional presence of cellular debris/material
in the alveolar lumina of a few of these animals suggests impaired or
insufficient clearance capacity of the alveolar macrophages, which is
considered to be an adverse reaction to the exposure with the test
compound. A No-Observed-Effect-Level (NOEL) could, therefore, not be
established. However, as the number of accumulated macrophages was small
and there was only a tiny amount of deposited material/cellular debris,
the concentration of 1 mg/m3 was considered to be a
Minimal-Observed-Adverse-Effect Concentration (MOAEC).
In the sub-chronic
(90-day) study with rats performed according to OECD guideline 413 and
under GLP, aluminium potassium fluoride concentrations of 0 (control),
0.32, 1.21, or 3.08 mg/m3 were investigated (TNO, 2004b,
Increases 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.
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.
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.
Based on the available
studies the overall NOAEC for local effects is 1.21 mg/m3.
The overall systemic NOAEC is >3.08 mg/m3.
tract effects were observed in rats after subchronic inhalation of
aluminium potassium fluoride from 3.08 mg/m3(0.00308 mg/L)
(90-day inhalation study, 6 hours/day, 5 days/week
(TNO, 2004b)). The NOAEC for these effects was 1.21 mg/m3(0.00121
mg/L). Under EU Classification, Labelling and Packaging of Substances
and Mixtures (CLP) Regulation (EC) No. 1272/2008, classification with
H372 (STOT, Cat. 1) is applicable for the inhalation route.
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