Reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate

Repeated dose toxicity: inhalation

Administrative data

Endpoint:

short-term repeated dose toxicity: inhalation

Type of information:

migrated information: read-across from supporting substance (structural analogue or surrogate)

Adequacy of study:

weight of evidence

Study period:

no data

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: Only lung, trachea and bronchial lymphnodes examined histopathologically, only one dose tested.

Data source

Reference

Reference Type:

publication

Title:

Toxicology of Ammonium Sulfate in the Lung.

Author:

Pepelko WE et al.

Year:

1980

Bibliographic source:

Bull Environ Contam Toxicol 24: 156-160.

Materials and methods

Principles of method if other than guideline:

Male rats were exposed to an aerosol of ammonium sulphate for up to 14 days.

GLP compliance:

not specified

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Ammonium sulphate

EC Number:

231-984-1

EC Name:

Ammonium sulphate

Cas Number:

7783-20-2

Molecular formula:

H8N2O4S

IUPAC Name:

diammonium sulfate

Details on test material:

- Name of test material (as cited in study report): ammonium sulfate
Particle size average 1-2 µm

Test animals

Species:

rat

Strain:

not specified

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
young adult male rats
- Weight at study initiation: mean weights: 435 +/- 20 g (control animals), 447 +/- 17 g (test animals)
- Housing: 2 per cage in 28-cn (11-inch) square wire cages
- Diet: ad libitum
- Water: ad libitum
No further data.

ENVIRONMENTAL CONDITIONS: no data

Administration / exposure

Route of administration:

inhalation: aerosol

Type of inhalation exposure:

whole body

Vehicle:

other: water

Details on inhalation exposure:

GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
Ammonium sulphate aerosol was generated from an aqueous solution with either one or two Retec nebulizers (Retec Development Laboratory, Portland, Oregon) and dried by mixing with dry air and passing it through a heated glass tube. Two nebulizers were used at concentrations greater than 500 mg/m³. Ammonium sulphate concentration was determined by collecting the aerosol on a Gelman A- E glass fiber filter at a flow rate of 2 l/min for 15 min and weighing the filter. Accuracy of the method was periodically checked by chemical analysis of the filter sample. Particle size was evaluated gravimetrically using an Andersen multi-stage sampler (Andersen Sampler Inc., Atlanta, Georgia).
No further data

Analytical verification of doses or concentrations:

yes

Details on analytical verification of doses or concentrations:

For description of the method, see above (Details on exposure)
Result of the atmosphere analysis: Particle size averaged approximately 1-2 µm diameter at 300 mg/m³. Concentrations of ammonium sulphate during exposures were maintained within +/- 10% of the desired concentration.

Duration of treatment / exposure:

1, 3, 7, or 14 days

Frequency of treatment:

8 h/day

Doses / concentrations

Remarks:

Doses / Concentrations:
300 mg/m³
Basis:
analytical conc.

No. of animals per sex per dose:

10 males per group

Control animals:

yes

Details on study design:

- Dose selection rationale:
The concentrations used were determined on basis of the results from a preliminary study with rats were exposed to the maximum attainable concentration of ammonium sulphate using the same equipment and methods, i.e. a group of 6 male rats were exposed 8 h/day for 3 consecutive days to a concentration of 1000-1200 mg/m³. No toxicological effects were noted in this pretest.

Results and discussion

Effect levels

Dose descriptor:

NOAEC

Effect level:

ca. 300 mg/m³ air

Based on:

test mat.

Sex:

male

Basis for effect level:

other: only one concentration tested, only lung, trachea and bronchial lymphnodes examined histopathologically.

Target system / organ toxicity

Critical effects observed:

not specified

Any other information on results incl. tables

Arterial blood gases, pH, and bicarbonate of rats exposed 1, 3, 7 or 14 days are shown in Table 1 (see attached file). No significant differences could be detected between control and exposed rats for any of the parameters measured.

Body weights, VC, RV and wet lung weights of rats exposed 14 days to 300 mg/m³ ammonium sulphate are shown in Table 2 (see attached file). Again, none of these parameters were significantly affected by exposure.

Histological examination of the trachea, bronchial lymph nodes and lungs revealed no changes that could be definitely attributed to exposure.

Conclusion:

The authors concluded that inhaled ammonium sulphate is relatively non-toxic except at very high concentrations. They also concluded that any concentration of sulfuric acid likely to be present in the atmosphere is probably non-toxic since the chances of neutralization to ammonium sulphate in the respiratory tract is very great.

Applicant's summary and conclusion

Executive summary:

Groups of ten adult male rats were exposed 8 h/day for 1, 3, 7 or 14 days at a concentration of about 300 mg/m³. After exposure, arterial blood samples were collected from the fully conscious animals and analyzed for blood gases, pH, and standard bicarbonate. Residual volume (RV) and vital capacity (VC) were determined in rats exposed for 14 days. Immediately after blood and lung volume measurements, the animals were sacrificed and the lungs fixed, sectioned, and stained with hematoxylin eosin for microscopic observation.

Blood parameters, body weights, VC, RV, and wet lung weights showed no significant differences between control and exposed rats for any of the parameters measured. Histological examination of the trachea, bronchial lymph nodes and lungs revealed no changes that could be definitely attributed to exposure.

The authors concluded that inhaled ammonium sulphate is relatively non-toxic except at very high concentrations. They also concluded that any concentration of sulfuric acid likely to be present in the atmosphere is probably non-toxic since the chances of neutralization to ammonium sulphate in the respiratory tract is very great.