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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
Endpoint summary
Administrative data
Description of key information
Based on read-across following an analogue approach:
Oral:
In an oral chronic toxicity study the NOAEL of ammonium sulphate was 256 and 284 mg/kg bw/day in males and females, respectively. Except for changes in organ weights, no treatment-related effects were noted.
Inhalation:
In the available studies, neither local effects in the respiratory tract nor signs of systemic toxicity were observed after repeated subacute exposure of rats to 300 mg/m³ of ammonium sulphate aerosol.
Key value for chemical safety assessment
Repeated dose toxicity: via oral route - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 256 mg/kg bw/day
- Study duration:
- chronic
- Species:
- rat
Repeated dose toxicity: inhalation - systemic effects
Endpoint conclusion
- Dose descriptor:
- NOAEC
- 300 mg/m³
- Study duration:
- subacute
- Species:
- rat
Additional information
Based on the available information on absorption, distribution, metabolism and excretion properties as well as the available toxicological data of all three components of the reaction mass, it can be concluded, that ammonium sulphate is the most critical substance within the reaction mass. Thus, available data on ammonium sulphate will be used for hazard assessment of the toxicological properties of the reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate:
Oral
Oral repeated dose toxicity was evaluated in a study equivalent to OECD guideline 453 (Ota et al., 2006). Groups of 10 male and female Fischer 344 rats were fed with a diet containing 0.1, 0.6, or 3% ammonium sulphate for 52 weeks, while 50 animals per group were fed with a diet containing 1.5 and 3 % ammonium sulphate for 2 years, respectively. While no mortality was observed during and after the 52 week dosing period, the survival rate during the 2 year study for control, 1.5% and 3.0% groups were 88%, 78% and 76% for males, respectively, and 76%, 80% and 80% for females, respectively. At the high dose level, the absolute and relative kidney weights were increased in both sexes, while absolute spleen weights were decreased. The relative liver weights were slightly increased only in the high dose males. No substance-related changes were found in all groups regarding body weight and weight-gain, haematological and clinical parameters, respectively. Gross pathology revealed no macroscopic changes different from that found in controls. The non-neoplastic and neoplastic lesions noted in the control and treatment groups were with no significant inter-group difference in their incidences or severity. Based on the result the NOAEL was estimated to be 0.6% ammonium sulphate in diet, corresponding to 256 mg/kg bw/d for males and 284 mg/kg bw/d for females, respectively.
In a subchronic study, groups of 10 male and female Fischer 344/DuCrj rats were fed with a diet containing 0.38, 0.75, 1.5, 3% ammonium sulphate for 13 weeks (Takagi et al., 1999). No substance-related effects were observed on body and organ weights as well as on haematological, serum biochemical, or histopathological examinations. However, diarrhoea was noted during the observation period in males of the 3% dose group. Based on these results, the NOAEL was set at 3% corresponding to 1792 mg/kg bw/day for males and 1975 mg/kg bw/day for females, respectively.
Inhalation
Groups of ten male rats were whole body exposed to an aerosol-concentration of 300 mg/m³ ammonium sulphate 8 h daily for 3, 7, or 14 days, respectively (Pepelko et al., 1980). The treatment did not alter arterial blood gases, pH, and bicarbonate. When body weights, vital capacity, respiratory volume and wet lung weights of rats exposed for 14 day were compared to controls, none of these parameters were significantly affected by the exposure. Histological examination of the trachea, bronchial lymph nodes and lungs also revealed no changes that could be definitely attributed to exposure. Thus, the NOAEC was set at 300 mg/m³air, the highest dose tested. In a pre-study, six male rats were exposed to an ammonium sulphate aerosol (1000 -1200 mg/m³) for three consecutive days (Pepelko et al., 1980). No gross toxicological effects were noted, so that a NOAEC of 1000 mg/m³ was defined.
Justification for classification or non-classification
Based on read-across, the available data on repeated dose toxicity are conclusive but not sufficient for classification according to the criteria of Directives 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP).
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