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EC number: 271-867-2 | CAS number: 68610-51-5
- 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
Basic toxicokinetics
Administrative data
- Endpoint:
- basic toxicokinetics
- Type of information:
- other: available information
- Adequacy of study:
- key study
- Study period:
- June - August 2010
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non GLP-assessment report
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
- Objective of study:
- other: toxicokinetic assessment
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Assessment of all available data
- GLP compliance:
- no
Test material
- Reference substance name:
- Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene
- EC Number:
- 271-867-2
- EC Name:
- Phenol, 4-methyl-, reaction products with dicyclopentadiene and isobutylene
- Cas Number:
- 68610-51-5
- Molecular formula:
- C10H12.C7H8O.C4H8
- IUPAC Name:
- 2-(8-{3-[8-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-4-yl]-2-hydroxy-5-methylphenyl}tricyclo[5.2.1.0²,⁶]decan-4-yl)-6-[4-(3-tert-butyl-2-hydroxy-5-methylphenyl)tricyclo[5.2.1.0²,⁶]decan-8-yl]-4-methylphenol
- Reference substance name:
- Phenyl, 4-methyl-, reaction products with dicyclopentadiene and isobutylene
- IUPAC Name:
- Phenyl, 4-methyl-, reaction products with dicyclopentadiene and isobutylene
- Details on test material:
- - Name of test material (as cited in study report): Lowinox CPL
- Physical state: solid
- Analytical purity: treated as 100% pure
Constituent 1
Constituent 2
Test animals
- Species:
- other: none
- Strain:
- other: none
Administration / exposure
- Route of administration:
- other: oral, dermal and inhalation
- Vehicle:
- unchanged (no vehicle)
- Details on exposure:
- see assessment
Results and discussion
Any other information on results incl. tables
The water solubility of Lowinox®CPL is very low (0.01 mg/L). Since in general a compound needs to be dissolved before it can be taken up from the gastro-intestinal tract, it is unlikely that Lowinox®CPL will show a high systemic exposure after oral administration (1). However, its highly lipophilic character (log Po/w 7.17 – 8.17) indicates that uptake by micellular solubilisation may be of particular importance. Lowinox®CPLwith its hydroxyl (OH) groups is potentially ionisable, and ionized substances do not readily diffuse across biological membranes. Also the relative high molecular weight of Lowinox®CPL (MW 700) is not favourable for absorption. For risk assessment purposes oral absorption of Lowinox®CPL is set at 50%. The results of the toxicity studies do not provide reasons to deviate from this proposed oral absorption factor.
Once absorbed the highly lipophilicLowinox®CPL(log P >6) is likely to distribute into cells and the intracellular concentration may be higher than extracellular concentration particularly in fatty tissues. Due to its lipophilicity,Lowinox®CPL may be present at higher concentrations in breast milk than in blood/plasma, and exposure of neonates via nursing to mother’s milk may have toxicological significance. Lowinox®CPLmay tend to concentrate in adipose tissue and depending on the conditions of exposure may accumulate in individuals that are frequently exposed (e.g. daily at work) Once exposure stops, the concentration within the body will decline at a rate determined by the half-life of the substance.Lowinox®CPLwith its hydroxyl (OH) groups may be conjugated as glucuronides and excreted in the bile and potentially undergo enterohepatic circulation.
The very low vapour pressure (< 3.2 x 10-5Pa) and the high boiling point (Decomposition > 300°C) indicate that Lowinox ®CPL is not available for inhalation as a vapour, but Lowinox ®CPL particles have the potential to be inhaled by humans (96.5% < 45 µm) . Particles with aerodynamic diameters below 50μm may reach the thoracic region and those below 15μm the alveolar region of the respiratory tract. Lowinox ®CPL particles depositing in the nasopharyngeal region could be coughed or sneezed out of the body or swallowed. Dusts depositing in the tracheo-bronchial region would mainly be cleared from the lungs by the mucocilliary mechanism and swallowed. The low water solubility of Lowinox ®CPL indicates a potential for accumulation, since the substance will not dissolve easily into the mucus lining of the respiratory tract and will not be transported out of the respiratory tract. Micellular solubilisation may be of particular importance for the highly lipophilic Lowinox ®CPL particles (log P7.17 – 8.17), which may have a longer half-life within the lungs. However a small amount may be taken up by phagocytosis and transported to the blood via the lymphatic system. Lowinox ®CPL dusts depositing in the alveolar region would mainly be engulfed by alveolar macrophages. The macrophages will then either translocate particles to the ciliated airways or carry particles into the pulmonary interstitium and lymphoid tissues. For risk assessment purposes the inhalation absorption of Lowinox ®CPL is set at 100%.
Lowinox®CPLmay penetrate the lipid rich stratum corneum but with a log P value of7.17 – 8.17, the rate of transfer between the stratum corneum and the epidermis will be slow and will limit absorption across the skin. Uptake into the stratum corneum itself may even be slow. At a molecular weight above 500 the molecule may also be too large for dermal uptake. AlthoughLowinox®CPLmay persist in the stratum corneum, it will eventually be cleared as the stratum corneum is sloughed off. With a molecular mass above 500 and log P outside the range [-1, 4],the data meet the criteria for 10% dermal absorption as given in the Guidance for the implementation of REACH (2) The results of the toxicity studies do not provide reasons to deviate from this proposed dermal absorption factor.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): other: see conclusions
For risk assesment purposes, the oral absorption is set at 50%.
For risk assessment purposes the inhalation absorption is set at 100%.
For risk asssessment purposes the dermal absorption is set at 10%.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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