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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Endpoint summary
Administrative data
Key value for chemical safety assessment
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:
In vitro Studies
Ammonium sulphate (purity 99.5%) was not mutagenic in bacteria when tested in the standard plate and pre-incubation Ames test performed according to OECD 471 (BASF, 1989). Four bacteria strains of Salmonella typhimurium (TA1535, TA100, TA1537, TA98) were treated with and without a metabolic activation system up to and including 5000 µg/plate. Besides the absence of mutagenicity, no cytotoxic effects were observed.
Ammonium sulphate (food grade) up to 50 mg/mL was also not mutagenic in bacteria strains Salmonella typhimurium TA1535, TA1537 and TA1538 when tested with and without metabolic activation systems (Litton Bionetics Inc., 1975). Again, no cytotoxic effects were observed up to the highest dose tested.
The potential of ammonium sulphate to induce gene mutations at the HPRT locus in V79 cells of the Chinese hamster was investigated in a study according to OECD 476 (BASF, 2010). The assay was performed in two independent experiments, using two parallel cultures. The first experiment was performed with and without liver microsomal activation and a treatment period of 4 h. The second experiment was performed with an exposure time of 4 h with metabolic activation and 24 h without metabolic activation. The highest test concentration of 1320 µg/mL was equal to a molar concentration of about 10 mM. No dose dependent increase of the mutation frequency was observed in both experiments. Thus, ammonium sulphate was found to be not mutagenic in this assay.
Chromosome aberration by ammonium sulphate was evaluated in a study similar to OECD 473 (Obe et al., 1986). Human lymphocytes were treated with ca. 423 mg/mL (3.2 M) ammonium sulphate without metabolic activation. While the effects of the restriction endonuclease Alu I on chromosomes were more pronounced when the cells were treated additionally with ammonium sulphate, no increase in chromosomal aberrations was found.
In another chromosome aberration test, treatment of Chinese Hamster Ovary (CHO) cells with ca. 105, 210 and 420 mg/mL (0.8, 1.6 and 3.2 M) ammonium sulphate in the absence of a metabolic activation system did not result in chromosomal aberrations (Tuschy and Obe, 1988). Ammonium sulphate again increased the frequency of chromosome type aberrations, which had been induced by the restriction endonuclease Alu 1. However, such an effect was also observed with other salts (magnesium chloride, calcium chloride and sodium chloride) demonstrating that this effect is not indicative of a direct genotoxic effect of ammonium sulphate but is attributed to the osmolarity of these salts.
Short description of key information:
Based on the read-across data from ammonium sulphate, the reaction mass of ammonium sulphate and potassium sulfate and sodium sulphate is considered not mutagenic in vitro.
Endpoint Conclusion: No adverse effect observed (negative)
Justification for classification or non-classification
Based on read-across, the available data on genetic toxicity are conclusive but not sufficient for classification according to the criteria of Directives 67/548/EEC (DSD) and Regulation 1272/2008/EC (CLP).
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.