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EC number: 277-633-6 | CAS number: 73912-21-7
- 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
- Study period:
- 1988-04-26 - 1988-05-10
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- Study conducted under GLP according to EU method B.1 on the registered substance itself. The method is to be considered scientifically reasonable with negligible deficiencies and methodological variations due to the intrinsic properties of the test item, which are foreseen in the guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- as published in 84/449/EWG
- Deviations:
- yes
- Remarks:
- limit dose only 2000 mg/kg
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin
- EC Number:
- 277-633-6
- EC Name:
- 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl-12H-dibenzo[d,g][1,3,2]dioxaphosphocin
- Cas Number:
- 73912-21-7
- Molecular formula:
- C27H35O3P
- IUPAC Name:
- 7,13-dicyclohexyl-5,15-dimethyl-9,11-dioxa-10-phosphatricyclo[10.4.0.0³,⁸]hexadeca-1(12),3(8),4,6,13,15-hexaen-10-ol
- Test material form:
- solid: flakes
- Details on test material:
- - Name of test material (as cited in study report): 12H-Dibenzo(d,g)(1,3,2)dioxaphosphocin, 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl
- Substance type: pure substance
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: strain Bor: WISW (Spf Cpb) from Breeder Winkelmann, Borchen, Germany
- Age at study initiation: 9 weeks (males), 14 weeks (females)
- Weight at study initiation (average): 172g (males), 173g (females), weight variation < ±20% of mean value
- Fasting period before study: 16h
- Housing: in groups of five in Makrolon cages Type III on dust-free wood pellets (Ssniff, Soest/Westfalen)
- Diet (e.g. ad libitum): fixed-formula standard diet Altromin 1324 Pellets (Altromin GmbH, Lage, Germany) ad libitum
- Water (e.g. ad libitum): tap water ad libitum
- Acclimation period: min. 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22±2°C
- Humidity (%): ca. 50±10%
- Air changes (per hr): ca. 10
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- polyethylene glycol
- Remarks:
- 400
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage): 20 ml/kg bw
MAXIMUM DOSE VOLUME APPLIED: 2 x 20 ml/kg bw
DOSAGE PREPARATION (if unusual): suspension - Doses:
- 2000 mg/kg, applied as 2 x 1000 mg/kg with a 6h interval
- 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: inspections twice daily (once on weekends and bank holidays), weighing prior application, after 1 week and at the end of the study
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight
Results and discussion
Effect levelsopen allclose all
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Sex:
- male
- Dose descriptor:
- LD0
- Effect level:
- >= 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- On the second day after treatment one female died.
- Clinical signs:
- other: Beginning ca. 1h after the first application of 1000 mg/kg a slightly ruffled fur was observed on all animals. This effect was rather slight and persisted until day 5 after application. One female was on the day after application in a poor general conditi
- Gross pathology:
- A pathological/anatomical examination of the dead female was not possible due to cannibalism.
All sacrificed animals at the end of the study were without pathological/anatomical findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: EU-GHS criteria not met
- Conclusions:
- The study was conducted under GLP according to EU method B.1 on the registered substance itself. The method is to be considered scientifically reasonable with negligible deficiencies and methodological variations due to the intrinsic properties of the test item, which are foreseen in the guideline. Hence, the results can be considered as sufficiently reliable to assess the acute oral toxicity in rats. The determined LD50 value is >2000 mg/kg bw, the LD0 ≥ 2000 mg/kg in male rats, as only one female died after gavage of 2000 mg/kg bw. The result is suitable to determine the classification of 12H-Dibenzo(d,g)(1,3,2)dioxaphosphocin, 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl. According to Directive 79/831/EWG, no classification is required. According to Regulation (EC) No. 1272/2008, the substance does not need to be classified as acute toxic cat. IV or higher.
- Executive summary:
In an acute oral toxicity study under GLP according to EU method B.1, groups of fasted 9-14 weeks old Wistar Bor: WISW (SPF Cpb) rats (5/sex) were given a single oral dose of 12H-Dibenzo(d,g)(1,3,2)dioxaphosphocin, 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl (2 x 1000 mg/kg bw with 6h interval) in polyethylenglycol 400 at a limit dose of 2000 mg/kg bw and observed for 14 days.
Oral LD50> 2000 mg/kg bw
Oral LD0≥ 2000 mg/kg bw (males)
One female died during the test after 2 days. One hour after application, ruffled fur was observed in all animals and lasted until day 6. At the end of the test, all animals were without pathological/anatomical findings.
12H-Dibenzo(d,g)(1,3,2)dioxaphosphocin, 4,8-dicyclohexyl-6-hydroxy-2,10-dimethyl is of low Toxicity based on the LD50 and does not need to be classified as acute toxic cat. IV or higher.
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