AMMONIUM SULFATE CAS N°: 7783-20-2

OECD SIDS
AMMONIUM SULFATE
5. TOXICITY ID: 7783-20-2
DATE: 18.04.2006
Conclusion: Exposure to levels of 300 mg/m3 (mean diameter
1-2 um) for up to 8 hours per day in 14 days did not
result in any significant changes in lung morphology, lung
volumes and arterial blood gases.
Reliability: (4) not assignable
limited documentation, no information on purity and particle
size distribution (SD), only lung, trachea and bronchial
lymphnodes examined, only one dose tested.
The interval between termination of exposure and examination
was too long.
Flag:
Critical study for SIDS endpoint
25-AUG-2005 (120)
Type:
Sub-acute
Species: rat Sex: male
Strain:
Sprague-Dawley
Route of administration: inhalation
Exposure period:
4 weeks
Frequency of treatment: 6 hours/day, 5 days/week
Post exposure period: no
Doses:
1.03 mg/m3 (MMAD 0.42 um)
Control Group:
other: sham exposed
Remark:
The study was designed to investigate effects of ammonium
sulfate in normal animals and animals pretreated with
elastase, which results in lung emphysema. Only the results
for ammonium sulfate vs. air controls are reported in detail.
Result: Pathological examination of rats exposed for 20 days to 1.03
mg/m3 ammonium sulfate aerosol revealed a measurable degree of
enlargement of alveoli, alveolar ducts and sacs. Alveolar pore
size was not increased.
The authors concluded that elastase pretreatment did not
enhance or even obscure the effect of ammonium sulfate on
alveolar structure at these exposure levels after short-term
treatment.
Test condition: Young adult specific pathogen free animals were maintained
in isolation for 3 weeks prior to beginning experimental
procedures. Animals were assigned to four experimental
groups based on their initial weights, so that the
distribution of animal weights for each treatment group was
the same. The animals were divided into two groups, one to
receive intratracheally instilled porcine pancreatic
elastase ("elastase impaired") and one to receive saline
solution intratracheally (controls). 40 rats received 75
units of elastase activity / 100 g bw. The dose level was
determined in preliminary experiments to produce a
predictable degree of emphysema without inducing significant
mortality. 40 rats received saline.
Sterile elastase or saline solutions, standardized for
activity (in the case of elastase), osmolarity, pH, and
temperature, were administered intratracheally to
ether-anesthetized animals. The total volume of the
instillate varied slightly, depending on animal weight;
however, concentration/volume was constant. Following
recovery from anesthesia, the animals were caged for a
3-week recovery period, during which (as in the initial
isolation period) rats were maintained on tetracycline
administered via drinking water. This procedure was found
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