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Diss Factsheets
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EC number: 914-103-1 | CAS number: -
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
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:
- 1 980
- 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
- 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
Constituent 1
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.
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