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Toxicological information

Exposure related observations in humans: other data

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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:
1979
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

Constituent 1
Chemical structure
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:
Monochloramine generated from ammonium sulphate and a chlorine source
Test material form:
solid: crystalline

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.

Applicant's summary and conclusion