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Diss Factsheets
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EC number: 940-936-5 | 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- The study is considered as reliable with restrictions since the study is conducted for the read-across substance, sodium hypochlorite. However, the data presented in the publication are sufficient and scientifically acceptable. Read-across justification: The target substance is a reaction mass from blending of two components (bentzotriazole solid and 25 % tetramethylammonium hydroxide water solution) followed by reaction with chlorine gas. The main constituent of this multi-constituent are tetramethylammonium hypochlorite and tetramethylammonium chloride. Based on the chemical structure and chemical reactions of chlorine compounds the target substance and the source substances (chlorinated bleaching agents such as sodium hypochlorite) meet the same toxicological behaviour in the physiological conditions. Their irritation and skin sensitisation as well as acute and long-term adverse effects to human health are similar. Therefore, and in order to avoid the unnecessary animal testing, the read-across data from sodium hypochlorite and chlorine is used to evaluate the toxicokinetics, the genetic toxicity, the sensitisation potential of the target substance.
Data source
Reference
- Reference Type:
- publication
- Title:
- Micronucleus Test in Mice on 39 Food Additives and Eight Miscellaneous Chemicals.
- Author:
- Hayashi et al
- Year:
- 1 988
- Bibliographic source:
- Fd. Chem. Toxic. Vol. 26, No. 6, pp. 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:
- micronucleus assay
Test material
- Reference substance name:
- Sodium hypochlorite
- EC Number:
- 231-668-3
- EC Name:
- Sodium hypochlorite
- Cas Number:
- 7681-52-9
- IUPAC Name:
- sodium hypochlorite
- Details on test material:
- - Name of test material (as cited in study report): sodium hypochlorite
- Composition of test material, percentage of components: 6.6 % as available Cl
Constituent 1
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 week old
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- - Vehicle(s)/solvent(s) used: saline
- Details on exposure:
- Number of doses: 1 (0, 312.5, 625, 1250, 2500 mg/kg)
4 (300 mg/kg) - Duration of treatment / exposure:
- single injection
- Frequency of treatment:
- Time between doses 24 hours (300mg/kg)
- Post exposure period:
- 24 hours
Doses / concentrationsopen allclose all
- Remarks:
- Doses / Concentrations:
0, 312.5, 625, 1250, 2500 mg/kg
Basis:
nominal conc.
one dose
- Remarks:
- Doses / Concentrations:
300 mg/kg
Basis:
nominal conc.
four doses
- No. of animals per sex per dose:
- 6
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- mitomycin C
Examinations
- Tissues and cell types examined:
- Mortality was observed during study. Bone marrow cells were collected and analyzed.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION:
The maximum dose were selected based on pilot experiment.
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields):
The sampling time after the administration was 24 hours.
DETAILS OF SLIDE PREPARATION:
Femoral bone marrow cells were flushed out with foetal bovine serum and smeared on clean glass slides. Cells were fixed with methanol for 5 min, and stained with Acridine orange for the pilot experiment and with Giemsa for the full scale test.
METHOD OF ANALYSIS:
One thousand polychromatic erythrocytes per mouse were scored using a light microscope with a high power objective (x100), and the number of micronucleated polychromatic erythrocytes (MNCPEs) was recorded. The proportion of polychromatic erythrocytes (PCEs) among the total erythrocytes was also evaluated by observing 1000 erythrocytes on the same slide.
OTHER:
Results and discussion
Test results
- Sex:
- male
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- Mortality (6/6) observed at highest concentration tested (2500 mg/kg)
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF DEFINITIVE STUDY
- Induction of micronuclei (for Micronucleus assay): No
- Ratio of PCE/NCE (for Micronucleus assay): see table below
Any other information on results incl. tables
Results of the micronucleus test with sodium hypochlorite in mice
Dose |
MNPCE [%] |
PCE [%] |
Mortalities |
0 |
0.17 ± 0.16 |
56.7 ± 14.8 |
0/6 |
312.5 |
0.20 ± 0.09 |
61.3 ± 3.8 |
0/6 |
625 |
0.22 ± 0.20 |
56.2 ± 9.8 |
0/6 |
1250 |
0.17 ± 0.08 |
29.3 ± 11.8 |
0/6 |
2500 |
-a |
- |
6/6 |
positive controlb |
3.77 ± 1.08 |
47.7 ± 18.9 |
0/6 |
300c |
0.17 ± 0.12 |
47.3 ± 9.8 |
0/6 |
MNPCE micronucleated polychromatic erythrocytes
PCE polychromatic erythrocytes
a Not evaluated due to mortalities
b 2.0 mg/kg bw Mitomycin C
c 4 doses of 300 mg/kg bw each, 24 hours spacing
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Read-across substance, sodium hypochlorite, was tested in mouse bone marrow micronucleus test. The test substance did not induce micronuclei in the bone marrow erythrocytes in mice. - Executive summary:
Six male mice of eight weeks old were intraperitoneally administered a single dose of sodium hypochlorite at concentrations of 0, 312.5, 625, 1250, 2500 mg/kg bw. In a second trial 4 doses of 300 mg/kg bw spaced by 24 hours were similarly administered. Femoral bone marrow cells were flushed out with foetal bovine serum and smeared on clean glass slides. Cells were fixed with methanol for 5 min, and stained with Acridine orange for the pilot experiment and with Giemsa for the full scale test. One thousand polychromatic erythrocytes per mouse were scored using a light microscope with a high power objective (x100), and the number of micronucleated polychromatic erythrocytes (MNCPEs) was recorded. The proportion of polychromatic erythrocytes (PCEs) among the total erythrocytes was also evaluated by observing 1000 erythrocytes on the same slide.
Based on this study no signs of genotoxicity was observed.
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