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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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January 28 - February 11, 2009
- 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:
- 2 011
- Report date:
- 2011
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- of 1987
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Version / remarks:
- of 2008
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1200 (Acute Dermal Toxicity)
- Version / remarks:
- of 1998
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: Japanese Ministry of Agriculture, Forestry and Fisheries (JMAFF), 12 Nousan, Notification No 8147, November 2000, including the most recent partial revisions.
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- standard acute method
- 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:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Wistar rats, strain: Crl:WI (Han) (outbred, SPF-Quality), with appropriate range of bodyweight at study start.
- Source: Charles River Deutschland, Sulzfeld, Germany.
- Age at study initiation (day of dosing): Approx. 12 weeks.
- Weight at study initiation( day of dosing): Mean (males): 337 g, minimum 324 g, maximum 349 g.
Mean (females): 211 g, minimum 207 g, maximum 217 g.
- Housing: Individual housing in M III type cages. (During acclimatization group housing in M IV type cages).
- Bedding material: Sterilized sawdust (Litalabo, S.P.P.S., Argenteuil, France).
- Cage enrichment: Paper (Enviro-dri, Wm. Lillico & Son (Wonham Mill Ltd), Surrey, UK).
- Diet (ad libitum): Commercially available rodent diet (SM R/M-Z from SSNIFF® Spezialdiäten GmbH, Soest, Germany).
- Water (ad libitum): Tap water
- Acclimation period: At least 5 days before treatment start under laboratory conditions.
Routine analysis of the sawdust, paper, diet and water, did not provide evidence of contamination that might have affected the study integrity.
ENVIRONMENTAL CONDITIONS
Animal housing and environmental conditions were appropriate for acute toxicity testing in the rat: Controlled environment with approximately 15 airchanges per hour, 12 hours artificial fluorescent light and 12 hours darkness per day, 19.0 - 20.5°C and 48 – 78% relative humidity. Due to a technical failure of the temperature and relative humidity sensors in the animal room in which in which the animals were housed, the temperature and relative humidity records were taken from another animal room connected to the same temperature and relative humidity regulation system and therefore considered to be representative for the present study.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- polyethylene glycol
- Remarks:
- 400 (Merck, Darmstadt, Germany)
- Details on dermal exposure:
- TEST SITE
- Preparation: One day before exposure an area of approximately 5x7 cm on the back of the animal was clipped. During health inspection of the animals prior to commencement of treatment, special attention was paid to the skin to be treated, which was intact and fre e from any abnormality.
- Area of treated skin: Ca. 25 cm2 in males, ca.. 18 cm2 in females corresponding to ca. 10% of total body surface.
- Type of wrap used: Surgical gauze patch (Surgy 1 D), successively covered with aluminium foil and Coban elastic bandage. For females additional
fixation of the bandage with Micropore tape.
REMOVAL OF TEST SUBSTANCE
Occlusive treatment of the clipped, intact skin lasted 24 hours. Then the dressings (gauze, foil, bandages, tape) were removed and residual test substance washed off the skin with tap-water.
TEST MATERIAL AND DOSE PREPARATION
- Administered Dose of test substance: 2000 mg/kg bw
- Administration Volume: 10 mL per kg body weight (specific gravity of the vehicle of 1.125 was accounted for)
The formulation (w/w) was prepared within 4 hours prior to dosing. Homogeneity was accomplished to a visually acceptable level.
- Justification for choice of vehicle:
Trial formulations at the testing laboratory and test substance data supplied by the sponsor led to the choice of this vehicle. - Duration of exposure:
- 24 hours
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- Duration of the observation period following administration start (day 1) was 14 days during which mortality/survival and clinical signs were recorded at: 0, 2 and 4 hours after administration start on day 1 and twice daily (mortality/survival) or once daily (clinical signs) thereafter until day 15. Body weight was recorded on days 1 (prior to administration), 8 and 15 for each animal. On day 15, all animals were necropsied and macroscopic pathology findings recorded.
- Statistics:
- Statistical analysis is inappropriate for this study, as there was only one dose group.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: No deaths at the limit dose of 2000 mg/kg.
- Mortality:
- There were no premature deaths.
- Clinical signs:
- other: Clinical signs were confined to Day 2, comprising of: - hunched posture in all animals (Nos. 1 to 10) - piloerection in two male animals (Nos. 1 and 4) and - chromodacryorrhoea (snout), slight in degree, in one male animal (No. 1).
- Gross pathology:
- Necropsy of each animal did not reveal any macroscopic pathology findings.
Applicant's summary and conclusion
- Interpretation of results:
- not classified
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- In view of the dermal LD50 > 2000 mg/kg bodyweight attained in the present study, its outcome does not necessitate any classification or labelling regarding acute dermal toxicity according to EU regulations (DIRECTIVE 67/548/EEC and REGULATION (EC) 1272/2008).
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