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EC number: 280-622-9 | CAS number: 83732-72-3
- 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 / bone marrow chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 28.08. - 12.11.2001
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 475 (Mammalian Bone Marrow Chromosome Aberration Test)
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- mammalian germ cell cytogenetic assay
Test material
- Reference substance name:
- Reference substance 002
- Cas Number:
- 90817-34-8
- Test material form:
- solid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Details on species / strain selection:
- The rat is an which has been used for many years as suitable experimental in cytogenetic investigations.
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Number of main animlas: 48 (24 males/24 females (nulliparous and non-pregnant))
Number of main animals per group: 6 and 6 females
Number of pretest animals: 2 and 2 females group
Age at start of acclimatization: 7 -10 weeks
Age at start of treatment pretest/ main study: 7-10 weeks/8-11 weeks
Body weight at start of acclimatization: 173.9-238.9 g
Body weight at start of treatment: 177.2-281.3 g
Acclimatization: Under laboratory conditions, after health examination.Only animals without any visible signs of illness will be used for the study.
Conditions: Air-conditioned with target for room temperature 22+/- 3°C, relative humidity 30-70 % and approximately 10-15 air changes per hour. Room temperature and humidity were monitored continuously and values outside of these occasionally occurred, following room These transient variations are considered not to have any influence on the study and, therefore, these data are not reported but are retained at RCC. The animals were provided with an automaticallylight cycle of 12 hours light and 12 hours dark. Music was played the light period.
Accomodation: Groups of three in Makrolon type-4 cages with wire. mesh top and Standard softwood bedding .
Diet: Pelleted Standard Kliba 3433, ad libitum
Water: tap water, ad libiitum
Administration / exposure
- Route of administration:
- intraperitoneal
- Vehicle:
- Natrium chloratum 0.9 %
- Details on exposure:
- dose volume: 10 ml/kg bw
- Duration of treatment / exposure:
- 24, 48 hours
- Frequency of treatment:
- single administration
Doses / concentrations
- Dose / conc.:
- 50 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 5
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- Substance: CPA; Cyclophosphamide
Dissolved in: NaCl-solution (0.9%)
Dosing: 15 mg/kg bw
Route and frequency of administration: intraperitoneally, once
Volume adminstered: 10 ml/kg bw
Results and discussion
Test results
- Key result
- Sex:
- male/female
- Genotoxicity:
- negative
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- In conclusion, it be stated that the test described and the experimental conditions the test item did not induce chromosome mutations as determined by the chromosome aberration test with bone marrow cells of the rat.
Therefore, the test substance is considered to be non-mutagenic in this chromosome aberration assay in vivo. - Executive summary:
This study was to investigate the potential of A130 to induce chromosome aberrations in bone marrow cells of the rat.
The test item was formulated in physiological (0.9 %) NaCl-solution. The volume asminstered intraperitoneally was 10 ml/kg body weight (b.w.). The animals were treated once. Twenty-four or 48 h, respectively, after the treatment the bone marrow cells were collected for chromosome aberration analysis. Ten animals (5males, 5 females) per test group were evaluated for the occurrence of cytogenetic darnage. Per animal 100 well spread metaphases were scored for gaps, breaks, fragments, deletions, multiple aberrations, and chromosomal disintegrations.
The test item was investigated in this cytogenetic assay at a single dose of 50 mg/kg b.w..
The dose for the cytogenetic assay was determined in pre-experiments for toxicity . 50 mg/kg b.w. were estimated as to be close to the maximum tolerated dose.
As compared to the vehicle control a reduction of the mitotic indices could be observed after treatment with the test item, indicating that the test item was cytotoxic item at the indicated dose in the bone marrow.
No biologically relevant or statistically significant increase in the frequency of aberrant cells occurred after treatment with the test item as compared to the vehicle control.
An appropriate reference mutagen (cyclophosphamide) was used as positive control and showed a distinct and statistically increase of induced aberration frequency.
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