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EC number: 829-608-1 | CAS number: 106396-29-6
- 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:
- From 2018-06-06 to 2018-06-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Version / remarks:
- 2001
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 2,4,8,10-tetra(tert-butyl)-6-hydoroxy-12H-dibenzo[d,g] [1,3,2]dioxaphosphocin, 6-oxide
- EC Number:
- 829-608-1
- Cas Number:
- 106396-29-6
- Molecular formula:
- C29 H43 O4 P
- IUPAC Name:
- 2,4,8,10-tetra(tert-butyl)-6-hydoroxy-12H-dibenzo[d,g] [1,3,2]dioxaphosphocin, 6-oxide
- Test material form:
- solid: particulate/powder
Constituent 1
- Specific details on test material used for the study:
- Purity: > 99%
Batch No.: 102Z4
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Beijing Vital River Laboratory Animal Technology Co., Ltd.
- Females (if applicable) nulliparous and non-pregnant: yes
- Age at study initiation: 51-60 days on arrival, in the range of 57-68 days at the commencement of each animal’s dosing
- Weight at study initiation: 207-236 g
- Fasting period before study: fasted overnight prior to dosing
- Housing: in suspended, stainless steel cages (L 32.0 cm × W 28.0 cm × H 20.0 cm) on cage racks (L 167.0 cm × W 70.0 cm × H 171.0 cm)
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 23.5 °C
- Humidity (%): 47% - 75%
- Photoperiod (hrs dark / hrs light): 12 hours light, 12 hours dark
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: Ultra-purified water
- Details on oral exposure:
- CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: According to the OECD Guideline for Testing of Chemicals: Acute Oral Toxicity-Acute Toxic Class Method (TG 423, adopted 2001) and relevant toxicity data (the acute oral LD50 of the active ingredient of test item in female rats is greater than 2000 mg/kg b.w.), the dose level of 2000 mg/kg b.w. was selected as the starting dose from one of four fixed dose levels (5, 50, 300, 2000 mg/kg b.w.) - Doses:
- the first step dosing: 2000 mg/kg b.w.
the second step dosing: 2000 mg/kg b.w. - No. of animals per sex per dose:
- three females in each dosing
- Control animals:
- no
- Details on study design:
- - Clinical observations: once during the first 30 minutes and at 1, 2 and 4 hours after application and then once each day for up to 14 days
- General observations: once daily for the animals which have not been administrated with the test item
- Frequency of weighing: on Day 0 (day of dosing), Day 7 and Day 14. At the end of the test surviving animals were weighed
- Necropsy of survivors performed: yes, including eye examinations of the abdominal, thoracic organs and their contents of all animals
- Moribund or Moritality inspection: made twice daily, morning and afternoon, during normal working days (except that it was made once in the dosing and necropsy days), and once daily at weekends and public holidays.
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mL/kg bw
- Based on:
- test mat.
- Mortality:
- The first dosing (2000 mg/kg b.w.): All animals showed no deaths or moribund status during the test.
The second dosing (2000 mg/kg b.w.): All animals showed no deaths or moribund status during the test. - Clinical signs:
- other: The first dosing (2000 mg/kg b.w.): All animals showed no abnormal symptoms during the course of the test. The second dosing (2000 mg/kg b.w.): All animals showed no abnormal symptoms during the course of the test.
- Gross pathology:
- No abnormalities were found in all animals under test at necropsy.
Applicant's summary and conclusion
- Interpretation of results:
- other: Category 5 or Unclassified
- Conclusions:
- The acute oral LD50 in rats for the test substance was estimated to be more than 2000 mg/kg b.w., and the cut-off value of LD50 was estimated to be 5000 or ∞ mg/kg b.w.
- Executive summary:
The study was performed to assess the acute oral toxicity of the test substance in Sprague Dawley rats according to the OECD Guideline for Testing of Chemicals: Acute Oral Toxicity-Acute Toxic Class Method (TG 423, adopted 2001).
The test item was tested using a stepwise procedure and three female animals were used each group. The first and second step dosing were both 2000 mg/kg b.w.. Clinical observations and body weights were monitored during the study. All animals under test were subjected to a gross necropsy at the end of the study.
Both the first dosing and the second dosing, all animals showed no deaths or moribund status during the test. All animals showed no abnormal symptoms during the course of the test in both dosing groups. Most of the surviving animals gained body weights during the test. No abnormalities were found in all animals under test at necropsy.
Based on the results, the acute oral LD50 in rats for the test substance was estimated to be more than 2000 mg/kg b.w. and the cut-off value of LD50 was estimated to be 5000 or ∞ mg/kg b.w..
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