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EC number: 442-450-4 | CAS number: -
- 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:
- 20 Feb - 13 Mar 2003
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 003
- Report date:
- 2003
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Version / remarks:
- adopted in 1987
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)
- Version / remarks:
- adopted in 2017
- Deviations:
- yes
- Remarks:
- no stepwise dosing approach, 5 animals/sex used
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- The Swiss GLP Monitoring Authorities, Bern, Switzerland
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- -
- EC Number:
- 442-450-4
- EC Name:
- -
- Cas Number:
- 203255-81-6
- Molecular formula:
- C42H61O4P
- IUPAC Name:
- 6-(3-(3-tert-Butyl-4-hydroxy-5-methylphenyl)propoxy)-2,4,8,1 0-tetra-tert-butyldibenz(d,f)(1,3,2)dioxaphosphepin
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Remarks:
- HanBrl: WIST
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: RCC Ltd, Biotechnology and Animal Breeding, Füllinsdorf, Switzerland
- Age at study initiation: 8 weeks (males) and 12 weeks (females)
- Weight at dosing: 249.3 - 290.2 g (males) and 190.6 - 207.8 g (females)
- Housing: During acclimatization in groups of 5/sex in Makrolon type-4 cages with standard softwood bedding. Individually in Makrolon type-3 cages with standard softwood bedding during treatment and observation.
- Diet: Pelleted standard Provimi Kliba 3433 rat/mouse maintainance diet (Provimi Kliba AG, Kaiseraugst, Switzerland), ad libitum
- Water: Community tap water, ad libitum
- Acclimation period: 20 - 26 Feb 2003
- Microbiological status when known : SPF
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70 (values > 70% during cleaning process possible)
- Air changes (per hr): 10 - 15
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Type of coverage:
- semiocclusive
- Vehicle:
- polyethylene glycol
- Remarks:
- PEG 300
- Details on dermal exposure:
- TEST SITE
- Area of exposure: clipped skin on the back of the animals
- % coverage: approximately 10%
- Type of wrap if used: The test material was held in contact with a semi-occlusive dressing. The dressing was wrapped around the abdomend and fixed with an elastic adhesive bandage.
REMOVAL OF TEST SUBSTANCE
- Washing: The skin was flushed with lukewarm tap water and dried with disposable paper towels.
- Time after start of exposure: 24 h
TEST MATERIAL
- Amount applied: 4 mL/kg bw
- Concentration: 0.5 g/mL
- Constant volume or concentration used: yes
VEHICLE
- Amount applied: 4 mL/kg bw - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- 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: The animals were observed daily during acclimatisation and twice daily during Days 1-5 for mortality and viabilitx. Clinical signs of toxicity were recorded daily during acclimatisation and at approx. 1, 2, 3 and 5 h after administration in test Day 1. Thereafter, the animals were observed once daily during Days 2-15.
- Frequency of weighing: On test Days 1 (prior to administration), 8 and 15
- Necropsy of survivors performed: Yes. All animals were killed at the end of the observation period by an intraperitoneal injection of Vetanarcol at a dose of at least 2.0 mL/kg body weight (equivalent to at least 324 mg sodium pentobarbitone/kg body weight) and underwent macroscopic examinations. No organs or tissues were retained. - Statistics:
- No statistical analysis was used.
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- No mortality occurred during the study period.
- Clinical signs:
- other: No systemic or local signs of toxicity were observed during the study period.
- Gross pathology:
- Necropsy and histopathological examination revealed no substance-related findings.
Applicant's summary and conclusion
- Interpretation of results:
- other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No. 1272/2008
- Conclusions:
- CLP: not classified
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