AMMONIUM SULFATE CAS N°: 7783-20-2

OECD SIDS
AMMONIUM SULFATE
5. TOXICITY ID: 7783-20-2
DATE: 18.04.2006
Test condition: 13 male healthy volunteers were exposed in chambers of the
U.S. EPA Human Studies facility to ammonium sulfate (0.133
mg/m3). The median mass diameter for the chemical specimen
was 0.55 µm. 10 men were exposed for 4 hours including 15
min treadmill exercise at 30 degrees C and 60 % relative
humidity. 19 parameters of pulmonary function (forced vital
capacity (FVC), forced expiratory volume in 1 sec (FEV1.0),
FEV1.0/FVC, forced expiratory flow at 25 % of FVC (FEF25),
forced expiratory flow at 50 % of FVC (FEF50), peak
expiratory flow (PEF), forced expiratory flow between 25 %
and 75 % of FVC (FEF 25-75), vital capacity (VC),
inspiratory capacity (IC), expiratory reserve volume (ERV),
forced inspiratory capacity (FIVC), forced air inspired at
1 sec (FIV 1.0), FIV1.0/FIVC, peak inspiratory flow (PIF),
forced inspiratory flow between 25 % and 75 % of FIVC
(FIF25-75), and forced inspiratory flow between inspired
volumes of 200 to 1200 ml (FIF200-1200), functional
residual capacity (FRC), airway resistance (RAW), specific
airway resistance (SRAW)) were measured just prior to
exposure (air control), 2 hr into exposure, following the
first exercise session, 4 hr into exposure, following the
second exercise session and 24 hr after exposure.
Reliability:
(2) valid with restrictions
valid with restrictions; no information on purity
Flag:
Critical study for SIDS endpoint
10-NOV-2003 (174)
Type of experience: other: controlled study
Remark:
212
Five normal subjects, 5 sensitive subjects and 6 asthmatics
were studied.
Neither significant functional changes nor consistent
changes in symptom score were found in the normal group at
low humidity. at high humidity, significant variation in
forced expiratory measures was detected, but the changes
were small in magnitude, and the performance tended to be
better on exposure days than on control days.
The sensitive group displayed small but significant
variations in pulmonary function at both low and high
humidity; once again, these appeared to be occurrences not
related to the aerosols. On the last exposure day of the
high-humidity studies, the sensitive subjects reported a
significant increase in total symptom score. Examination of
the individual symptoms reports indicated that his was due
to increased fatigue.
The asthmatic subjects showed a marginal decrease in the
slope of the alveolar plateau of the single breath N2
washout between the beginning and the end of exposure, both
with clean air and with exposure to ammonium sulfate. In
the
absence of other changes in function, this would be
interpreted as representing an increase in uniformity of
ventilation distribution within the bungs, i.e., an
improvement in function. Symptom scores and other pulmonary
function results did not indicate any increase toward
dysfunction.
In conclusion, no evidence of an adverse health effect on
healthy, sensitive and asthmatic adult men was found after
2
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