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EC number: 806-801-9 | CAS number: 1539267-56-5
- 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:
- 28 October 2014 to 02 December 2014
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 014
- Report date:
- 2014
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Version / remarks:
- 2001
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- Version / remarks:
- 2008
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- yes
Test material
- Reference substance name:
- ethyl (3-benzoyl-2,4,6-trimethylbenzoyl)(phenyl)phosphinate
- EC Number:
- 806-801-9
- Cas Number:
- 1539267-56-5
- Molecular formula:
- C25H25O4P
- IUPAC Name:
- ethyl (3-benzoyl-2,4,6-trimethylbenzoyl)(phenyl)phosphinate
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Appearance: Off white powder.
- Storage conditions: Room temperature in the dark.
Constituent 1
- Specific details on test material used for the study:
- STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: For the purpose of the study the test material was freshly prepared as required as a suspension in arachis oil BP.
- Stability under storage conditions: The test material was formulated within two hours of being applied to the test system. It is assumed that the formulation was stable for this duration.
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source : Harlan Laboratories UK Ltd., Oxon, UK.
- Females nulliparous and non-pregnant: Yes
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: The body weight variation did not exceed ± 20 % of the body weight of the initially dosed animal.
- Fasting period before study: Yes. Animals were fasted overnight immediately before dosing and for approximately 3 - 4 hours after dosing.
- Housing: Animals were housed in groups of up to 4 in suspended solid-floor polypropylene cages furnished with woodflakes.
- Diet: Ad libitum, 2014C Teklad lobal Rodent diet (Harlan Laboratories UK Ltd., Oxon, UK).
- Water: Ad libitum
- Acclimation period: At least 5 days.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 - 25 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): At least 15 air changes per hour.
- Photoperiod (hrs dark / hrs light): 12 hours continuous light and 12 hours darkness.
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- arachis oil
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 200 mg/mL
- Justification for choice of vehicle: The vehicle was selected as the test material did not dissolve/ suspend in distilled water.
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg - Doses:
- 2 000 mg/kg bw
- No. of animals per sex per dose:
- 5 females
- Control animals:
- no
- Details on study design:
- All animals were dosed once only by gavage, using a metal canula attached to a graduated syringe. The volume administered to each animal was calculated according to the fasted body weight at the time of dosing. Treatment of animals was sequential. Sufficient time was allowed between each dose level to confirm the survival of the previously dose animals.
- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations were made half, 1, 2, and 4 hours after dosing and then daily thereafter for 14 days. Morbidity and mortality checks were made twice daily. Individual body weights were recorded on the day of dosing and on days 7 and 14.
- Necropsy of survivors performed: Yes. At the end of the observation period the animals were killed by cervical dislocation and all animals were subjected to gross necropsy, which consisted of an external examination and opening of the abdominal and thoracic cavities. The appearance on any macroscopic abnormalities was recorded.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD0
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None of the animals died during the study.
- Clinical signs:
- other: Hunched posture and exophthalmos were noted in all animals. Tiptoe gait was also noted in two animals. Animals appeared normal 4 hours, 1 or 4 days after dosing.
- Gross pathology:
- No abnormalities were noted at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Under the conditions of the study the acute oral LD0 of the test material was determined to be higher than 2 000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the test material was investigated in a study which was conducted in accordance with the standardised guidelines OECD 420 and EU Method B.2 bis, under GLP conditions.
Following a sighting test at a dose level of 2 000 mg/kg, an additional four fasted female Wistar strain rats were given a single oral dose of test material, as a suspension in arachis oil BP, at a dose level of 2 000 mg/kg bw. Clinical signs and bodyweight development were monitored during the study. All animals were subjected to gross necropsy.
Under the conditions of the study, none of the animals died. Hunched posture and exophthalmos were noted in all animals. Tiptoe gait was also noted in two animals. Animals appeared normal 4 hours, 1 or 4 days after dosing. Three animals showed expected weight gains over the observation period. Two animals showed body weight loss during the first week with expected gain in body weight during the second week. No abnormalities were noted at necropsy.
The acute oral LD0 of the test material was therefore determined to be higher than 2 000 mg/kg bw.
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