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Endpoint:
specific investigations: other studies
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: Unusual animal model, data well documented
Principles of method if other than guideline:
Sheep were exposed to aerosol of ammonium sulfate for 20 min and 4 h. Tracheal mucous velocity was determined.
GLP compliance:
not specified
Type of method:
in vivo
Endpoint addressed:
not applicable
Species:
sheep
Route of administration:
inhalation: aerosol
Analytical verification of doses or concentrations:
yes
Duration of treatment / exposure:
20 min and 4 hours
Dose / conc.:
1.1 other: mg/m³
No. of animals per sex per dose:
6 sheep (experiment 1);
5 sheep (experiment 2)
Control animals:
other: exposure to room air or to an aerosol generated from a 0.1% NaCl solution

Breathing for 20 min of aerosol generated from 0.1% NaCl (mass concentration: 1.0 mg/m³) in conscious sheep did not

significantly affect tracheal mucous velocity over a 3-h observation period, as compared to room air. The 20-min exposure to an aerosol of ammonium sulfate did not significantly alter tracheal mucous velocity. Finally, there were no significant changes of t

racheal mucous velocity with the 4-h exposure to an aerosol of the test substance.

Endpoint:
specific investigations: other studies
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: No standard study, but well documented.
Principles of method if other than guideline:
no data
GLP compliance:
not specified
Type of method:
in vivo
Species:
rabbit
Strain:
New Zealand White
Sex:
male
Details on test animals or test system and environmental conditions:
TEST ANIMALS
male New-Zealand White SPF rabbits
- Weight at study initiation: 3.0 - 3.5 kg
- Housing: individually in stainless-steel cages
- Diet: Purina Rabbit Chow HF, ad libitum
- Water: ad libitum

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C
- Humidity (%): 50%

No further data.
Route of administration:
inhalation: aerosol
Vehicle:
not specified
Duration of treatment / exposure:
14 days
Frequency of treatment:
2 h/day
Dose / conc.:
2 other: mg/m³

The response of respiratory clearance depended on total exposure, i.e., some combination form of C x T, and was also related to relative acidity when sulfuric acid (H2SO4), ammonium bisulfate (HN4HSO4), and ammonium sulfate ((NH4)2SO4) were

investigated. Ammonium sulfate exposure (2 mg/m³) of 5 rabbits for 2 h/d on 14 consecutive days resulted in no statistically significant change in clearance. Respiratory region clearance was measured by evaluating the retention of 85Sr-tagged polystyrene latex microspheres (3.5 µm MMAD) by daily profile scanning.

Description of key information

The effects of inhalation exposure to an aerosol generated from solutions of the test substance on lung functions was studied in sheep (Sackner et al, 1981). The 20-min exposure to an aerosol of ammonium sulfate did not significantly alter tracheal mucous velocity. Finally, there were no significant changes of tracheal mucous velocity with the 4-h exposure to an aerosol of the test substance.
In another study, rabbits were exposed by inhalation to an aerosol of the test substance and the effect on pulmonary clearance was investigated (Schlesinger, 1989). The response of respiratory clearance depend on total exposure, i.e., some combination form of C x T, and was also related to relative acidity when sulfuric acid (H2SO4), ammonium bisulfate (HN4HSO4), and ammonium sulfate ((NH4)2SO4) were investigated. Ammonium sulfate exposure (2 mg/m³) of 5 rabbits for 2 h/d on 14 consecutive days resulted in no statistically significant change in clearance.

Additional information

Acute inhalation exposure to an aerosol of ammonium sulafe did not adversely affect respiratory clearance (see also section 7.2.2)