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EC number: 243-869-3 | CAS number: 20544-37-0
- 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
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)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 407 (Repeated Dose 28-Day Oral Toxicity Study in Rodents)
- GLP compliance:
- yes
- Limit test:
- no
Test material
- Reference substance name:
- 3,9-dibenzyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
- EC Number:
- 243-869-3
- EC Name:
- 3,9-dibenzyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
- Cas Number:
- 20544-37-0
- Molecular formula:
- C19H22O6P2
- IUPAC Name:
- 3,9-dibenzyl-2,4,8,10-tetraoxa-3λ⁵,9λ⁵-diphosphaspiro[5.5]undecane-3,9-dione
- Test material form:
- solid: particulate/powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Hino Breeding Center, CHARLES RIVER LABORATORIES JAPAN, INC.
- Numbers and sex of animal received: 32 females and 32 males
- Age: at arrival: 5 weeks; at administration initiation: 6 weeks
- Weight range at arrival: males 119.2 - 136.9 g (Allowable range: 100 - 150 g); females 93.2 - 106.8 g (Allowable range: 70 - 120 g)
- Acclimation: The duration of quarantine is 5 days after the arrival and the duration of assimilation is 7 days (including that of the quarantine).
- Housing: cage stainless steel (W226 x D346 x H198 mm), individually breeding
ENVIRONMENTAL CONDITIONS
- Temperature: 23.5 - 24.4°C (measured) (allowable range: 21 - 27°C)
- Humidity: 51.1 - 64.9% (measured) (allowable range: 35 - 75%)
- Ventilation: 10 - 20 / hour
- Lighting: 7 - 19 o'clock lighting
Administration / exposure
- Route of administration:
- oral: gavage
- Details on route of administration:
- Oral administration (gavage oral administration) was performed using a disposable syringe fitted with a gastric tube for rat. The administration solution was used after well stirring with a magnetic stirrer.
It was administered once a day for 28 days at a time between 8:34 to 12:56 (allowable range: 8:00 to 14:00). - Vehicle:
- CMC (carboxymethyl cellulose)
- Remarks:
- 0.5%CMC-Na aqueous solution
- Duration of treatment / exposure:
- 28 days
- Frequency of treatment:
- everyday
Doses / concentrationsopen allclose all
- Dose / conc.:
- 100 mg/kg bw/day (nominal)
- Dose / conc.:
- 300 mg/kg bw/day (nominal)
- Dose / conc.:
- 1 000 mg/kg bw/day (nominal)
- No. of animals per sex per dose:
- 3 dose groups plus control
control: 10
100 mg/kg bw: 5
300 mg/kg bw: 5
1000 mg/kg bw: 10 - Control animals:
- yes, concurrent vehicle
Results and discussion
Results of examinations
- Clinical signs:
- no effects observed
- Description (incidence and severity):
- For all groups no special toxicological impact has been observed.
- Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Clinical biochemistry findings:
- no effects observed
- Urinalysis findings:
- no effects observed
- Behaviour (functional findings):
- no effects observed
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Gross pathological findings:
- no effects observed
Effect levels
- Key result
- Dose descriptor:
- NOEL
- Effect level:
- 1 000 mg/kg bw/day (nominal)
- Based on:
- test mat.
- Basis for effect level:
- clinical signs
- mortality
Target system / organ toxicity
- Key result
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- For all groups no special toxicological impact has been observed. From these results, the NOEL for repeated dose toxicity are considered to be 1000 mg/kg/day.
- Executive summary:
The test substance was repeatedly administered at 0 (control), 100, 300 and 1,000 mg/kg to male and female rats Cri: CD (SD) (SPF) everyday for 28 days to observe changes in the function and morphology of the body and their toxicity and recovery ere examined. In the control group, only vehicle (0.5 %(w/v) CMC-Na aqueous solution) was administered. The number of animals in each group was 5 males and 5 females, and in the control group and 1,000 mg / kg group, 14 days recovery group ( male and female, 5 animals/group each)) were designed.
As a result, all examination items, general clinical observation, functional observation examination, body weight, food consumption, hematological examination, blood biochemistry examination, urinalysis, organ weight, pathological anatomical examination and pathological examination, no changes were found due to the administration of the test substance.
Therefore, the no observed effect level (NOEL) of 3,9-dibenzyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide
under this test condition was judged to be 1,000 mg/kg body weight for male and female each.
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