Ammonium sulphate

Specific investigations: other studies

Link to relevant study record(s)

Reference

Reference 1

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.

Reference 2

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)