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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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute 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:
- 2 019
- Report date:
- 2019
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- GLP compliance:
- yes
- Test type:
- fixed dose procedure
- 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
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- lot No. of test material: 44216018
- Purity test date: 99.9 %
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: The test substance was put into an air-tight brown container and stored in test substance storage room at room temperature (acceptable range: from 10°C to 30°C).
- Stability under test conditions: Stable against water and heat
FORM AS APPLIED IN THE TEST: Vehicle of the dosing formulation was examined under non-GLP. Although the test substance did not dissolve and was not suspended to purified water at a concentration of 20 w/v%, the test substance was suspended to olive oil at a concentration of 20 w/v%. The condition of the formulation such as color did not change at room temperature four hours after the preparation. Therefore, olive oil was selected as a vehicle.
Test animals
- Species:
- rat
- Strain:
- Crj: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories Japan (Hino Breeding Center)
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: eight or nine weeks old
- Weight at study initiation: 196.8 g for the 1st sighting study, 207.8 g for the 2nd sighting study and from 216.3 g to 222 g for the main study
- Fasting period before study: 17 to 18 hours before the administration, and for three to four hours after the administration.
- Housing: stainless steel cages with mesh-floor (260W×380D×180H mm) before the group allocation and in stainless steel cages with mesh-floor (165W×300D×150H mm) after the group allocation allocation
- Diet (e.g. ad libitum): pelleted diet (MF, lot number 181224181224, Oriental Yeast) ad libitum
- Water (e.g. ad libitum): Chlorinated water in which chloric level maintained from 3 to 5 ppm by adding sodium hypochlorite (Purelox) to Hita City supply water was used as drinking water ad libitum
- Acclimation period: one week
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 - 25
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- olive oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 3 and 20%
MAXIMUM DOSE VOLUME APPLIED: 10 ml/kg
DOSAGE PREPARATION (if unusual):
- Rationale for the selection of the starting dose: Since no toxic ity information about the test substance was available, the dose level of the 1st sighting study was set at 3 00 mg/kg. The dose level of the 2nd sighting study and main study were set at 2000 mg/kg a ccord ing to the test method. - Doses:
- 300 and 2000 mg/kg
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed continuously for 10 minu tes after the administration, and observed 30 minutes and three hours after the administration on the administration day. The animals were observed once in the morning from 1 to 14 days after the administration. Body weights were measured 0 (before administration), 1, 7 and 14 days after the administration.
- Necropsy of survivors performed: yes/
- Other examinations performed: clinical signs, body weight, organ weights, histopathology
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality or moribundity occurred.
- Clinical signs:
- other: No abnormalities associated with test substance dosing were observed in the general clinical observation.
- Gross pathology:
- No abnormalities associated with test substance dosing were observed in necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The hazard class of the acute oral toxicity of 3,9-dibenzyl-2,4,8,10-tetraoxa-3,9-diphosphaspiro[5.5]undecane 3,9-dioxide in rats under the tested conditions was classified to “unclassified” of Globally Harmonized System of Classification and Labelling of Chemicals, because no mortality or moribundity occurred and no evident toxicity was observed in the sighting study or main study at 2000 mg/kg.
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