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EC number: 231-968-4 | CAS number: 7782-89-0
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- study well documented, meets generally accepted scientific principles, acceptable for assessment
Data source
Reference
- Reference Type:
- publication
- Title:
- Micronucleus Tests in Mice on 39 Food Additives and Eight Miscellaneous Chemicals
- Author:
- Hayashi, M. et al.
- Year:
- 1 988
- Bibliographic source:
- Food and Chemical Toxicology, 26(6): 487-500
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- other: micronucleus assay
Test material
- Reference substance name:
- Ammonium chloride
- EC Number:
- 235-186-4
- EC Name:
- Ammonium chloride
- Cas Number:
- 12125-02-9
- Molecular formula:
- ClH4N
- IUPAC Name:
- ammonium chloride
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- other: ddY strain
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Laboratory Animals, Japan
- Age at study initiation: 8 weeks
- Diet: ad libitum, CE-2 pellets (Japan Clea, Tokyo)
- Water: ad libitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle used: no data
- Duration of treatment / exposure:
- 24 hours
- Frequency of treatment:
- singly within 24 hours; and 4 injections within 24 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 31.3 mg/kg bw (total dose)
- Dose / conc.:
- 62.5 mg/kg bw (total dose)
- Dose / conc.:
- 125 mg/kg bw (total dose)
- Dose / conc.:
- 250 mg/kg bw (total dose)
- Dose / conc.:
- 500 mg/kg bw (total dose)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
Examinations
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
The doses were determined via pre-tests. Up to the maximum tolerated dose was used.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): Two experimental set ups were performed. A single dose was applied in the first experiment at dose levels of 0, 62.5, 125, 250 or 500 mg/kg bw. In the second experiment four injections were given within 24 hours using dose leves of 31.3, 62.5, 125 or 250 mg/kg bw.
DETAILS OF SLIDE PREPARATION: The bone marrrow cells were rinsed with foetal bovine serum. Afterwards the cells were fixed with methanol and stained with Giemsa.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- not examined
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
Micronucleated erythrocytes occurred to a degree of 0.12 % after single injection. 0.17 % were observed after four injections.
Applicant's summary and conclusion
- Conclusions:
- No genotoxicity was observed during the micronucleus test with ammonium sulfate.
- Executive summary:
In a mouse bone marrow micronucleus assay equivalent or similar to OECD guideline 474, 5 male ddY mice per dose were treated intraperitoneal (ip) with ammonium chloride at doses of 0, 62.5, 125, 250 or 500 mg/kg bw or as four injections within 24 hours at dose levels of 31.3, 62.5, 125 or 250 mg/kg bw. Bone marrow cells were harvested at 24 hours post treatment. No vehicle was indicated. The maximum tolerated dose was tested. 1000 PCEs were evaluated per animal and the number of micronucleated erythrocytes was recorded. Based on the findings no evidence of genotoxicity has been observed under the experimental conditions described.
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