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EC number: 425-180-1 | CAS number: 66170-10-3
- 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
Repeated dose toxicity: oral
Administrative data
- Endpoint:
- short-term repeated dose toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- other company data
- Title:
- Unnamed
- Year:
- 2 000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: 96/54/EG, B.7; OECD 407 (1995)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- -
- EC Number:
- 425-180-1
- EC Name:
- -
- Cas Number:
- 66170-10-3
- Molecular formula:
- C6H6Na3O9P
- IUPAC Name:
- trisodium (2R)-2-[(1S)-1,2-dihydroxyethyl]-5-oxo-4-(phosphonatooxy)-2,5-dihydrofuran-3-olate
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- other: rat, Wistar Chbb:THOM (SPF)
- Strain:
- other: Wistar Chbb:THOM (SPF)
Administration / exposure
- Route of administration:
- oral: unspecified
- Details on oral exposure:
- Method of administration:
Trinkwasser (drinking water) - Duration of treatment / exposure:
- Test duration: 28 days
- Frequency of treatment:
- Dosing regime: 7 days/week
- No. of animals per sex per dose:
- Male: 5 animals at 0 mg/kg bw/day
Male: 5 animals at 83 mg/kg bw/day
Male: 5 animals at 424 mg/kg bw/day
Male: 5 animals at 1426 mg/kg bw/day
Female: 5 animals at 0 mg/kg bw/day
Female: 5 animals at 90 mg/kg bw/day
Female: 5 animals at 512 mg/kg bw/day
Female: 5 animals at 1662 mg/kg bw/day
Results and discussion
Results of examinations
- Details on results:
- Clinical observations:
The males (1426 mg / kg) and females (1662 mg / kg) of the 15000 ppm dose showed an increased water consumption. Studies on neurofunction did not reveal any effects on the nervous system.
no. of studies subacute: 1
no. of applications/duration: 28x/28 d recovery period:
14d
species: rat
route of application: oral (drinking water)
Relevant toxic effects:
dose levels (mg/kg): 1000 5000 15000 rec/15000
no. of animals/sex: 5m 5f 5m 5f 5m 5f 5m 5f
water consum increased X X X
organ weight
increased absolute ovary weight X
microscopic findings
-organ system/lesion
urinary bladder/urothel hyperplasia 5X 1X
urinary bladder/cystitis 4X
thymus/starry sky cells increased 3X 4X
Comment:
The substance concentrations were equivalent to 83, 424, and 1426 mg/kg in males and 90, 512, and 1662 mg/kg in females. The primary toxic effect induced by the test substance was urothel hyperplasia in males and one female of the high dose groups and cystitis in high dose males. Increased occurrence of starry sky cells in the thymic cortex indicating increased thymocyte cell death/apoptosis was not corroborated by other immunotoxic effects. Therefore it was considered of minor toxicological significance. Microscopic lesions were absent in the ovaries with lower absolute weights. All effects beside increased water consumption were reversible.
No-observed-adverse-effect-level (NOAEL):
90 mg/kg in female rats, 424 mg/kg in male rats
Laboratory findings:
No treatment related effects.
Effects in organs:
The absolute ovary weight was reduced in the females of the high dosage; there was no morphological correlate.
In the thymus of three females of the 512 mg / kg dose, star sky macrophages were increasingly detected in the cortex area. All males of the 1426 mg / kg dose had mild to moderate diffuse hyperplasia of the urinary bladder epithelium; four males of this dose had cystitis, and one of these males also showed ulceration of the urothelium. Poor multifocal hyperplasia of the urinary bladder epithelium has been demonstrated in a female of the high dose. In four females of this dosage, more starry sky cells were found in the thymus cortex.
After the end of the recovery period, all effects were reversible with the exception of increased water consumption in the females.
Effect levels
open allclose all
- Dose descriptor:
- NOAEL
- Effect level:
- 90 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
- Dose descriptor:
- NOEL
- Effect level:
- 90 mg/kg bw/day (nominal)
- Basis for effect level:
- other: original NCD unit is mg/kg/day.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Classified as: Not classified
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