Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Carcinogenicity
Administrative data
Description of key information
No evidence of a carcinogenic potential was observed in a combined chronic toxicity/carcinogenicity study with rats exposed to ammonium sulphate following closely the requirements of OECD TG 453. Additionally, there are no indications that the substance may cause carcinogenicity by a direct genotoxic mechanism as the results of all genotoxicity studies (mutagenicity and cytogenicity) were negative.
Similarly to other salts, high doses of ammonium sulphate may have the capability of tumour promotion in the rat stomach. It is, however, much less potent than sodium chloride when tested under identical conditions. However, these data need careful evaluation as high salt concentrations were given as a bolus dose directly into the stomach. It is known that high salt concentrations can denature proteins leading to cell injury or cell death. Subsequently cell proliferation might occur as a repair mechanism causing an increase in ornithine decarboxylase in the glandular stomach.
Key value for chemical safety assessment
Carcinogenicity: via oral route
Endpoint conclusion
- Dose descriptor:
- NOAEL
- 1 288 mg/kg bw/day
Justification for classification or non-classification
Based on read-across, the available data on carcinogenicity are conclusive but not sufficient for classification according to the criteria of Directives 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP).
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:
A chronic oral toxicity and carcinogenicity study was conducted in Fischer 344 rats, similar to the requirements of OECD 453 (Ota et al., 2006). In the chronic part of the study, groups of 10 rats/sex were fed a diet containing ammonium sulphate at concentrations of 0.1, 0.6, or 3% for 1 year, corresponding to average daily intakes of 42, 256, and 1527 mg/kg bw/d for males and 48, 284, and 1490 mg/kg bw/d for females, respectively. For investigation of the carcinogenic potential, groups of 50 rats/sex were fed a diet containing the test substance at concentrations of 1.5, or 3% for 2 years. These concentrations corresponded to average daily intakes of 564.1, and 1288.2 mg/kg bw/d for males and 649.9, and 1371.4 mg/kg bw/d for females, respectively. The examinations revealed that the absolute and relative kidney weights were increased at the high dose level for both sexes. Absolute spleen weights were decreased and relative liver weights were increased in high dose males, while no macroscopic changes different from that found in controls were recorded. At histopathological examination, non-neoplastic and neoplastic lesions were noted in the control and treatment groups, with no significant inter-group difference in their incidences or severity. Based on the results it can be concluded that ammonium sulphate is non-carcinogenic under the conditions of the study. Thus, the no observed adverse effect level (NOAEL) of ammonium sulphate regarding carcinogenicity is the highest dose given, which is equivalent to 1288.2 and 1371.4 mg/kg bw/d in males and females, respectively.
In addition, there is no evidence that the substance may cause carcinogenicity by a direct genotoxic mechanism as the results of all genotoxicity studies (mutagenicity and cytogenicity) were negative.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.