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EC number: 231-984-1 | CAS number: 7783-20-2
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Exposure related observations in humans: other data
Administrative data
- Endpoint:
- exposure-related observations in humans: other data
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- no data
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Limited documentation
Data source
Reference
- Reference Type:
- publication
- Title:
- Controlled Exposures Of Human Volunteers To Sulfate Aerosols. Health Effects And Aerosol Characterization.
- Author:
- Avol EL et al
- Year:
- 1 979
- Bibliographic source:
- Am Rev Respiratory Disease 120: 319-327.
Materials and methods
- Type of study / information:
- controlled study
- Endpoint addressed:
- acute toxicity: inhalation
- Principles of method if other than guideline:
- Both healthy and asthmatic adult men were exposed for 2 hour period to ammonium sulfate under controlled conditions (particle size distribution and concentration). Lung function tests were performed.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Ammonium sulphate
- EC Number:
- 231-984-1
- EC Name:
- Ammonium sulphate
- Cas Number:
- 7783-20-2
- Molecular formula:
- H3N.1/2H2O4S
- IUPAC Name:
- diammonium sulfate
- Test material form:
- solid: crystalline
Constituent 1
Method
- Exposure assessment:
- measured
Results and discussion
Any other information on results incl. tables
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.
Table 2 Mean Pulmonary Function measures for normal subjects exposed to ammonium sulfate (31°C)
|
Low Humidity (40%)* |
High Humidity (85%)† |
||||||||
|
condition |
Control Day 1 |
Exp. Day 1 |
Exp. Day 2 |
Exp. Day3 |
Control Day 1 |
Control Day 2 |
Exp. Day 1 |
Exp. Day 2 |
Exp. Day3 |
FVC |
Pre |
5.22 |
5.30 |
5.28 |
5.17 |
5.31 |
5.48 |
5.46 |
5.53 |
5.52 |
|
Post |
5.20 |
5.18 |
5.18 |
5.22 |
5.42 |
5.38 |
5.44 |
5.45 |
5.50 |
FEV1 |
Pre |
4.46 |
4.43 |
4.38 |
4.35 |
4.50 |
4.60 |
4.59 |
4.65 |
4.58 |
|
Post |
4.44 |
4.37 |
4.41 |
4.40 |
4.59 |
4.56 |
4.63 |
4.58 |
4.60 |
FEF |
Pre |
4.67 |
4.58 |
4.61 |
4.63 |
4.78 |
4.82 |
4.77 |
4.78 |
4.54 |
|
Post |
4.80 |
4.70 |
4.69 |
4.66 |
5.03 |
4.88 |
4.93 |
4.88 |
4.77 |
∆N2 |
Pre |
0.87 |
0.79 |
0.79 |
0.73 |
0.69 |
0.59 |
0.69 |
0.65 |
0.58 |
|
Post |
0.78 |
0.75 |
0.73 |
0.73 |
0.59 |
0.59 |
0.71 |
0.68 |
0.53 |
TLC |
Pre |
6.20 |
6.24 |
6.21 |
6.23 |
7.21 |
7.14 |
6.50 |
7.17 |
7.16 |
|
Post |
6.15 |
6.26 |
6.19 |
6.30 |
7.17 |
7.08 |
6.55 |
7.13 |
7.12 |
RV |
Pre |
1.23 |
1.23 |
1.27 |
1.17 |
1.49 |
1.45 |
1.18 |
1.38 |
1.29 |
|
Post |
1.20 |
1.22 |
1.23 |
1.23 |
1.41 |
1.42 |
1.26 |
1.38 |
1.42 |
Rt ‡ |
Pre |
2.30 |
2.38 |
2.27 |
2.38 |
4.37 |
2.95 |
3.10 |
3.31 |
2.56 |
(6Hz) |
Post |
3.13 |
2.32 |
2.33 |
2.55 |
3.77 |
3.45 |
3.19 |
3.06 |
3.28 |
Definitions of abbreviations:Exp. = exposure to aerosol, FVC = forced vital capacity, FEV1= forced expiratory volume in 1s, FEF = forced expiratory flow during the middle half of the FVC,∆N2determined via single-breath N2test, TLC = total lung capacity, RV= residual volume, Rt= total respiratory resistance
*No significant variations,
†Significant (P<0.05) variation among pre-exposure measurements for FVC, FEV1, ∆N2, TLC, and RV; significant variations among pre-to post-exposure changes for FVC.
‡Resistance data were available for only 3 of the 5 subjects exposed to low humidity.
Table 3 Mean Pulmonary Function measures for sensitive subjects exposed to ammonium sulfate (31°C)
|
Low Humidity (40%)* |
High Humidity (85%)† |
|||||||||
|
condition |
Control Day 1 |
Control Day 2 |
Exp. Day 1 |
Exp. Day 2 |
Exp. Day 3 |
Control Day 1 |
Control Day 2 |
Exp. Day 1 |
Exp. Day 2 |
Exp. Day3 |
FVC |
Pre |
5.06 |
5.14 |
5.07 |
5.05 |
5.01 |
5.47 |
5.53 |
5.53 |
5.54 |
5.49 |
|
Post |
5.08 |
5.08 |
5.09 |
5.05 |
4.99 |
5.55 |
5.45 |
5.60 |
5.39 |
5.55 |
FEV1 |
Pre |
3.97 |
4.05 |
3.95 |
4.00 |
3.98 |
4.31 |
4.23 |
4.26 |
4.19 |
4.31 |
|
Post |
4.02 |
4.10 |
4.10 |
4.06 |
4.03 |
4.35 |
4.29 |
4.40 |
4.19 |
4.35 |
FEF |
Pre |
3.60 |
3.65 |
3.54 |
3.74 |
3.63 |
3.57 |
3.51 |
3.55 |
3.49 |
3.74 |
|
Post |
3.75 |
3.90 |
4.05 |
3.90 |
3.91 |
3.68 |
3.77 |
3.88 |
3.55 |
3.74 |
∆N2 |
Pre |
0.73 |
0.70 |
0.71 |
0.71 |
0.72 |
0.82 |
0.73 |
0.76 |
0.77 |
0.83 |
|
Post |
0.67 |
0.64 |
0.68 |
0.65 |
0.73 |
0.64 |
0.73 |
0.73 |
0.82 |
0.82 |
TLC |
Pre |
6.83 |
6.42 |
6.98 |
6.26 |
6.26 |
6.78 |
6.81 |
6.88 |
6.80 |
7.19 |
|
Post |
6.65 |
6.45 |
7.02 |
6.29 |
6.28 |
5.68 |
5.77 |
6.79 |
6.85 |
7.23 |
RV |
Pre |
1.17 |
1.10 |
1.24 |
1.02 |
1.12 |
1.29 |
1.22 |
1.31 |
1.28 |
1.58 |
|
Post |
1.13 |
1.06 |
1.16 |
1.15 |
1.05 |
1.24 |
1.20 |
1.17 |
1.27 |
1.59 |
Rt |
Pre |
3.46 |
2.39 |
2.54 |
2.62 |
2.67 |
2.71 |
3.17 |
2.71 |
2.76 |
2.63 |
(6Hz) |
Post |
3.69 |
2.06 |
2.47 |
2.23 |
2.19 |
1.86 |
2.53 |
2.63 |
3.02 |
2.88 |
*Significant (P<0.05) variation among pre-exposure measurements for TLC, RV and Rt; significant variations among pre-to post-exposure changes for RV.
†Significant (P<0.05) variation among pre-exposure measurements for TLC and RV; significant variations among pre-to post-exposure changes for TLC.
For definitions of abbreviations, see table 2.
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