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EC number: 604-012-2 | CAS number: 137296-15-2
- 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
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:
- Fd Chem Toxic Vol 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:
- mammalian erythrocyte micronucleus test
Test material
- Reference substance name:
- Ammonium chloride
- EC Number:
- 235-186-4
- EC Name:
- Ammonium chloride
- Cas Number:
- 12125-02-9
- IUPAC Name:
- ammonium chloride
Constituent 1
- Specific details on test material used for the study:
- - Name of the test substance: Ammonium chloride
- Purity: 99.7%
Test animals
- Species:
- mouse
- Strain:
- other: ddY
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Shizuoka Agricultural Cooperative Association for Laboratory Animals, Shizuoka, Japan
- Age at study initiation: 8 weeks
- Weight at study initiation: no data
- Diet (e.g. ad libitum): food pellets CE-2 (Japan Clea, Tokyo), ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: physiol. saline
- Details on exposure:
- Six male mice per dose group were used and the test item was administered by intraperitoneal injection.
- Duration of treatment / exposure:
- Experiment 1: single exposure plus 24 h post treatment incubation
Experiment 2: multiple dosing (4 times) at 24 h intervals plus 24 h post treatment incubation - Frequency of treatment:
- Experiment 1: once
Experiment 2: 4 times (not specified in detail) at 24 h intervals - Post exposure period:
- 24 hours
Doses / concentrationsopen allclose all
- Dose / conc.:
- 62.5 mg/kg bw/day (nominal)
- Remarks:
- single dosing (experiment 1)
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Remarks:
- single dosing (experiment 1)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Remarks:
- single dosing (experiment 1)
- Dose / conc.:
- 500 mg/kg bw/day (nominal)
- Remarks:
- single dosing (experiment 1)
- Dose / conc.:
- 31.3 mg/kg bw/day (nominal)
- Remarks:
- multiple dosing (experiment 2)
- Dose / conc.:
- 62.5 mg/kg bw/day (nominal)
- Remarks:
- multiple dosing (experiment 2)
- Dose / conc.:
- 125 mg/kg bw/day (nominal)
- Remarks:
- multiple dosing (experiment 2)
- Dose / conc.:
- 250 mg/kg bw/day (nominal)
- Remarks:
- multiple dosing (experiment 2)
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Mitomycin C, 2.0 mg/kg bw
Examinations
- Tissues and cell types examined:
- Tissue: Bone marrow
Cell type examined: Erythrocytes - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The maximum dose of the test item was determined by a pilot experiment using the multi-sampling at multi-dose levels method [Hayashi et al. 1984. Mutation Research 141: 165].
DETAILS OF SLIDE PREPARATION: Mice were killed by cervical dislocation at the appropriate time after administration. Femoral marrow cells were flushed out with foetal bovine serum and smeared on clean glass sides. Cells were fixed with methanol for 5 min and stained with Giemsa.
METHOD OF ANALYSIS: The preparations were coded and analysed without any knowledge of the treatment. One thousand polychromatic erythrocytes per mouse were scored using a light microscope and the number of micronucleated polychromatic erythrocytes (MNPCE) was recorded. The proportion of polychromatic erythrocytes among the total erythrocytes was also evaluated by observing 1000 erythrocytes on the same slide. - Evaluation criteria:
- The frequencies of MNPCEs in concurrent negative and positive control groups were compared with the control charts of our historical data to confirm the technical validity of the experiment.
- Statistics:
- The dose-response relationships were tested using the Cochran-Armitage trend test. A positive dose-response was considered significant at p < 0.05.
Results and discussion
Test results
- Key result
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- See Table 1 (box "any other information on results incl. tables")
Any other information on results incl. tables
Table 1: Summary of the results | ||||||||||||||
Compound | Vehicle | Route | Number of doses | Time between doses (hr) |
Sampling time (hr) |
Dose level (mg/kg bw) |
MNPCE (%) |
PCE (%) |
Mortality | |||||
Single dosing | ||||||||||||||
Ammonium chloride | Saline | ip | 1 | 24 | 0 | 0.18 ± 0.18 | 56.8 ± 4.7 | 0/6 | ||||||
62.5 | 0.12 ± 0.12 | 60.9 ± 4.2 | 0/6 | |||||||||||
125 | 0.15 ± 0.14 | 61.7 ± 3.8 | 0/6 | |||||||||||
250 | 0.13 ± 0.05 | 64.3 ± 2.5 | 0/6 | |||||||||||
500 | 0.12 ± 0.08 | 56.9 ± 6.1 | 0/6 | |||||||||||
Mitomycin C | ip | 1 | 24 | 2.0 | 4.18 ± 1.30* | 52.3 ± 4.6 | 0/6 | |||||||
Repeated dosing | ||||||||||||||
Ammonium chloride | Saline | ip | 4 | 24 | 24 | 0 | 0.20 ± 0.09 | 59.9 ± 8.3 | 0/6 | |||||
31.3 | 0.25 ± 0.19 | 67.2 ± 13.5 | 0/6 | |||||||||||
62.5 | 0.17 ± 0.10 | 63.7 ± 4.5 | 0/6 | |||||||||||
125 | 0.20 ± 0.18 | 64.0 ± 9.2 | 0/6 | |||||||||||
250 | 0.17 ± 0.08 | 61.6 ± 6.9 | 0/6 | |||||||||||
Mitomycin C | ip | 1 | 24 | 2.0 | 7.15 ± 3.92* | 32.2 ± 11.0 | 0/6 |
*= statistically significant (p< 0.01)
Applicant's summary and conclusion
- Conclusions:
- Under the reported experimental conditions Ammonium chloride did not induce structural and/or numerical chromosomal damage in the bone marrow cells of the mouse.
- Executive summary:
In a ddY mouse bone marrow micronucleus test conducted similar to OECD guideline 474, six male mice per dose were treated intraperitoneally with Ammonium chloride (99.7% purity) at doses of 0, 62.5, 125, 250 and 500 mg/kg bw (experiment 1) and at doses of 0, 31.3, 62.5, 125 and 250 mg/kg bw (experiment 2). The animals were injected intraperitoneally with the test substance once (experiment 1) or four times at 24 h intervals (experiment 2) with an additional 24 hours period after the last dosing. The vehicle was physiological saline. Ammonium chloride did not increase the level of micronuclei in comparison to the concurrent vehicle control. Thus, Ammonium chloride is considered to be non-mutagenic according to the results of the in vivo micronucleus test reported.
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