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EC number: 700-627-6 | CAS number: 17270-01-8
- 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:
- other: Well documented and reported study fully adequate for assessment. The study was conducted according to internationally accepted technical guidelines and in compliance with GLP in a recognized contract research organization.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- of 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- of 2004
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- 4'-[(diphenoxyphosphoryl)oxy]-[1,1'-biphenyl]-4-yl diphenyl phosphate
- EC Number:
- 700-627-6
- Cas Number:
- 17270-01-8
- Molecular formula:
- C36H28O8P2
- IUPAC Name:
- 4'-[(diphenoxyphosphoryl)oxy]-[1,1'-biphenyl]-4-yl diphenyl phosphate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Sprague Dawley rats, strain: Crl:CD (SD) IGS BR with appropriate range of bodyweight at study start.
- Source: Charles River UK Ltd., Margate, Kent, UK.
- Age at study start (day of dosing): 8 to 12 weeks.
- Weight at start (day of dosing): Females: minimum 205 g, maximum 243 g.
- Housing: Group housing with up to 4 animals in suspended solid-floor propylene cages.
- Bedding material: Woodflakes.
- Fasting period: Overnight immediately prior to dosing until 3-4 hours post administration.
- Diet (ad libitum, except for fasting period): Commercially available standard laboratory animal diet:
Certified Rat and Mouse Diet
- Water (ad libitum*): Mains drinking water
- Acclimation period: At least 5 days before start of dosing.
* Remark: The study report does not clearly state whether or not water was supplied during the fasting period.
ENVIRONMENTAL CONDITIONS
The animal room was maintained at target ranges of:
- Temperature (°C): 22 ± 3°C
- Relative Humidity (%): 30 to 70%
- Photoperiod: 12 h day / 12 h night
- Rate of air exchange: At least 15 changes/h
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- DMSO
- Details on oral exposure:
- VEHICLE
- Target dose of test material --- Concentration of test material in vehicle: 300 mg/kg bw --- 30 mg/mL
2000 mg/kg bw --- 200 mg/mL
- Amount (dose volume by gavage): 10 mL/kg bw
(individual dose volume was calculated based on individual fasted bodyweight at the time of dosing).
DOSAGE PREPARATION:
The test material, was freshly prepared as a solution in dimethyl sulphoxide (DMSO). DMSO was used as a vehicle, because the test material did not dissolve in distilled water or arachis oil BP.
RATIONALE FOR DOSE SELECTED:
The choice of the limit dose of 2000 mg/kg bw was appropriate in the main test, because doses of 300 mg/kg and 2000 mg/kg did not induce any deaths, clinical signs of toxicity, adverse effects on bodyweight or necropsy findings in sequential preliminary sighting studies with 1 female rat/dose. - Doses:
- 300 mg/kg bw (1 female)
2000 mg/kg bw (5 females) - No. of animals per sex per dose:
- 5 (females only)
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing:
Observation of clinical signs: 0.5, 1, 2 and 4 h post dosing on the day of administration (Day 0) and subsequently once daily for 14 days.
Weighing of each animal: Day 0 for dose calculation and on Days 7 and 14.
- Necropsy performed: yes, of all sighting and main study animals. - Statistics:
- Not applicable, as there were no deaths
Results and discussion
- Preliminary study:
- There were no deaths, clinical signs of toxicity, adverse effects on bodyweight or necropsy findings in a preliminary sighting study at a dose of 300 mg/kg bw administered to 1 female rat.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths at 300 mg/kg (sighting) and at the limit dose of 2000 mg/kg
- Mortality:
- Single Dose at Mortality
300 mg/kg 0/1 (f)
2000 mg/kg 0/5 (f) - Clinical signs:
- other: Clinical signs of systemic toxicity were not evident.
- Gross pathology:
- Necropsy of each animal at the end of the 14-day post treatment observation period did not reveal any macroscopic pathology findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information No deaths at 300 mg/kg (sighting) and at the limit dose of 2000 mg/kg Criteria used for interpretation of results: EU
- Conclusions:
- In view of the oral LD50 > 2000 mg/kg bodyweight attained in the present study, its outcome does not necessitate any classification or labelling regarding acute oral toxicity according to EU regulations (DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008).
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