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EC number: 231-984-1 | CAS number: 7783-20-2
- 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

Endpoint summary
Administrative data
Description of key information
There are no data available concerning the skin sensitation potential of ammonium sulfate. A read across from an analogous substance was used. Thereby, in an in vivo study, a guinea pig maximization test, for the structural analogue ammonium chloride no skin sensitizing potential was reported (Hoechst AG, 1986).
There are no animal studies available
concerning the respiratory sensitation. In a study on humans, both
healthy, "sensitive" and asthmatic adult men were exposed to ammonium
sulfate, ammonium bisulfate, and sulfuric acid (Alvol E.L. et al.,
1979). In a second study, pulmonary function and bronchial reactivity to
metacholine was studied after exposure to an ammonium sulfate aerosol
(Kulle et al., 1984). In a third study, thirteen male healthy volunteers
were exposed to ammonium sulfate (Stacy R.W. et al. 1983). In a forth
study a panel of 16 laboratory workers inhaled ammonium sulfate (Utell
M.J. et al. 1982). No sensitizing effect was observed in all studies
after exposure to ammonium sulfate.
Key value for chemical safety assessment
Skin sensitisation
Link to relevant study records
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Qualifier:
- according to guideline
- Guideline:
- other: EPA 540/9-82-025
- GLP compliance:
- yes
- Type of study:
- guinea pig maximisation test
- Justification for non-LLNA method:
- The Guinea Pig Maximazitation Test met the previous requirements before the entry into force of REACH. The GPMT is suitable and reliable to cover this endpoint. For this reason and for animal welfare reasons, no further in vivo study (LLNA test) needs to be performed.
- Species:
- guinea pig
- Strain:
- other: Pirbright-White
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: breeder
- Age at study initiation: about 8 weeks
- Mean weight at study initiation: 240 g
ENVIRONMENTAL CONDITIONS: not reported - Route:
- other: 1st: intracutaneous, 2nd: occlusive epicutaneous
- Vehicle:
- other: 0.9% NaCl solution
- Concentration / amount:
- 1st Induction: 5%, 2nd Induction 25 %, 3rd: Challenge: 10 %.
- Route:
- epicutaneous, occlusive
- Vehicle:
- other: 0.9% NaCl solution
- Concentration / amount:
- 1st Induction: 5%, 2nd Induction 25 %, 3rd: Challenge: 10 %.
- No. of animals per dose:
- 20
- Details on study design:
- MAIN STUDY
A. INDUCTION EXPOSURE
1st application: Induction 5 % intracutaneous
2nd application: Induction 25 % occlusive epicutaneous
B. CHALLENGE EXPOSURE
3rd application: Challenge 10 % occlusive epicutaneous
METHOD
Day 1 : Intradermal induction exposure (Injection): The injection sites were not covered.
Day 1-7: The application area was investigated.
Day 9 : Dermal induction exposure: 0.5ml of the test substance preparation were applied to a cellulose patch of 2x4 cm. This patch covered
the area of the intradermal injection sites. An occlusive dressing with impermeable foil and an elastic bandage sealed the application site for 48 hours.
Day 11 : Removal of the occlusive dressing. Recording of the irritation.
Day 22 : Dermal challenge exposure. 0.5ml of test substance preparation were applied to a cellulose patch and placed onto the clipped skin of the flank. An occlusive dressing with impermeable foil and an elastic bandage sealed the application site for 24 hours.
Day 23 : Removal of the occlusive dressing.
Day 24-25: Assessment of the skin. - Key result
- Reading:
- other: 1st and 2nd reading
- Group:
- test chemical
- Dose level:
- ca. 76.5 mg
- No. with + reactions:
- 2
- Total no. in group:
- 20
- Clinical observations:
- 24 and 48 hours after removal of the occlusive dressing, very slight, hardly perceptible erythema
- Remarks on result:
- other: see Remark
- Remarks:
- Reading: other: 1st and 2nd reading. Group: test group. Dose level: ca. 76.5 mg. No with. + reactions: 2.0. Total no. in groups: 20.0. Clinical observations: 24 and 48 hours after removal of the occlusive dressing, very slight, hardly perceptible erythema .
Reference
1) The treated animals did not show any
signs of toxicity throughout the study period.
2) Induction: Very slight to slight edema were observed in the treatment
group.
3) Challenge: 24 and 48 hours after removal of the occlusive dressing, a
total of 2 animals (in 20) of the treatment group showed
very slight, hardly perceptible erythema.
Ten percent of the animals of treatment group demonstrated a positive
reaction after the challenge exposure
(the criteria: the limit value of 30 percent).
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Animal Data
In a guinea pig maximization test (Hoechst AG, 1986) conducted with the analogous substance ammonium chloride according GLP and according to EPA 540/9-82-025, a test group of 20 animals received 5% ammonium chloride in vehicle (physiological saline) for intracutaneous induction, followed by epicutaneous induction with 0.5 ml 25% ammonium chloride in vehicle under occlusive dressing for 48 hours. For challenge, 0.5 ml of a 10% solution in vehicle was applied to the intact clipped skin with a 24 hour covered patch (occlusive). Ten percent of the animals demonstrated a positive reaction after the challenge exposure (below the limit value of 30 percent). The study showed that the substance had no sensitizing potential.
Respiratory sensitisation
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed (not sensitising)
- Additional information:
Human data
In a study on humans, both healthy, "sensitive" and asthmatic adult men were exposed to nominal (100 µg/m³) concentrations of ammonium sulfate, ammonium bisulfate, and sulfuric acid with a mass median aerodynamic diameter (MMAD) of 0.3-0.6 µm and a relative humidity ranging between 40 and 85% (Alvol et al., 1979). The study showed no evidence of an adverse health effect on healthy, sensitive and asthmatic adult men.
In the second study (Kulle et al., 1984), pulmonary function and bronchial reactivity to metacholine was studied in 20 non-smoking subjects after a 4 -hour exposure to an ammonium sulfate aerosol (528 +/- 39 µg/m³, mass median diameter: 0.97 +/- 0.05 µm) and was shown not to be affected.
In a third study (Stacy et al., 1983), thirteen male healthy volunteers were exposed to ammonium sulfate (0.133 mg/m³) with a MMAD for the chemical specimen of 0.55 µm for 4 hours including 15 min treadmill exercise at 30°C and 60% relative humidity. Exposure to ammonium sulfate caused no significant effects on any pulmonary function of healthy men.
In a forth study (Utell et al., 1982), 16 normal (mean age 27 years) subjects inhaled a control NaCl aerosol followed by ammonium sulfate (particles with an average MMAD of approximately 0.5-1.0 µm and concentrations of 0.1 and 1 mg/m³). At 1 mg/m³ quite small changes in flow on the maximum expiratory flow-volume (MEFV) and partial expiratory flow-volume (PEFV) curves was observed, which may be based on improved flow rates caused by sodium chloride inhalation resulting in statistical significance, despite the relatively small reduction in flow.
For details see Section 7.10.5 Exposure related observations in humans.
Justification for classification or non-classification
Classification,
Labelling, and Packaging Regulation (EC) No 1272/2008
The available experimental test data are reliable and suitable for classification purposes under Regulation (EC) No 1272/2008. The substance is not considered to be classified for skin sensitisation under Regulation (EC) No 1272/2008, as amended for the ninth time in Regulation (EU) No 2016/1179. Based on the human data, classification concerning respiratory sensitisation is not warranted.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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