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EC number: 413-850-6 | CAS number: 123968-25-2 SUMILIZER GS
- 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: Toxicokinetic assessment
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Acceptable expert judgement meeting basic scientific principles.
Data source
Reference
- Reference Type:
- other: Expert judgement
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
- Objective of study:
- absorption
- Principles of method if other than guideline:
- Expert judgement and calculation of the absorption of Sumilizer GS based on physico-chemical properties.
- GLP compliance:
- no
Test material
- Reference substance name:
- 2-(1-(2-hydroxy-3,5-di-tert-pentyl-phenyl)ethyl)-4,6-di-tert-pentylphenyl acrylate
- EC Number:
- 413-850-6
- EC Name:
- 2-(1-(2-hydroxy-3,5-di-tert-pentyl-phenyl)ethyl)-4,6-di-tert-pentylphenyl acrylate
- Cas Number:
- 123968-25-2
- Molecular formula:
- C37H56O3
- IUPAC Name:
- 2-{1-[2-hydroxy-3,5-bis(2-methylbutan-2-yl)phenyl]ethyl}-4,6-bis(2-methylbutan-2-yl)phenyl prop-2-enoate
- Reference substance name:
- 2-(1-(2-hydroxy-3,5-di-tert-pentylphenyl)ethyl)-4,6-di-tert- pentylphenylacrylate
- IUPAC Name:
- 2-(1-(2-hydroxy-3,5-di-tert-pentylphenyl)ethyl)-4,6-di-tert- pentylphenylacrylate
Constituent 1
Constituent 2
Results and discussion
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Oral absorption was set at 1 %.
Inhalation absorption was considered negligible.
Dermal absorption of 1 % (equivalent to oral absorption) was considered to be more appropriate, although 10% was derived from physical/chemical properties according to TGD.
Metabolite characterisation studies
- Metabolites identified:
- not measured
Any other information on results incl. tables
Sumilizer GS is a solid with a very low water solubility (< 5x10-6g/L). Since in general a substance needs to be dissolved before it can be taken up from the gastro-intestinal tract (1), it is unlikely that Sumilizer GS will show a high exposure after oral administration. The absorption will furthermore be lowered by the relatively large molecular size (molecular weight of 548 g/mol, estimated Dmaxaverage(average maximum diameter) of 1.5 to 2.5 nm) of this substance limiting the passage through biological membranes. In addition, Sumilizer GS is a lipophilic substance (log POW> 6.2, and calculated as > 10) and in general, highly lipophilic substances (log POW> 4) are not easily absorbed via passive diffusion. Uptake via micellular solubilisation might be restricted due to its relatively large particle size (only 0.3 % < 106 μm). Overall, it is expected that Sumilizer GS will be absorbed to a limited extent in the gastrointestinal tract. For risk assessment purposed the oral absorption of Sumilizer GS is set at 1 %. The results of the toxicity studies do not provide reasons to deviate from this proposed oral absorption.
After absorption of Sumilizer GS from the gastrointestinal tract, metabolism may occur in the liver (3).
The relatively low vapour pressure / high boiling point indicate that the substance is not available for inhalation as a vapour. The particle size (0.3% < 106 μm) indicates that there are no inhalable/respirable particles present. Based on these properties, no respiratory exposure and hence no inhalation absorption is to be expected. If however during use of the product particles between 100 and 10 μm are generated, these will deposit in the nasopharyngeal region and subsequently be coughed or sneezed out of the body or swallowed. Particles below 10 μm might reach the tracheobronchial or pulmonary regions. Based on its low water solubility (<5x10-6g/L) Sumilizer GS will not dissolve into the mucus lining the respiratory tract. Following its lipophilic character (log POW> 6.2) Sumilizer GS has the potential to be absorbed directly across the respiratory tract epithelium, however, the absorption will be lowered for the same reason explained in the above paragraph. It is thus concluded that for risk assessment purposes, the potential for inhalation absorption of Sumilizer GS might be considered negligible.
Sumilizer GS being a solid with a relative high molecular weight has no real potential for dermal absorption. Furthermore, its low water solubility and lipophilic character do not facilitate dermal absorption. As the criteria for 10 % dermal absorption as given in the TGD (2) (MW > 500 and log POW>4) are met, 10 % dermal absorption is proposed for risk assessment purposes. It is, however, generally accepted that dermal absorption is lower compared to oral absorption. The 10 % dermal absorption derive from physical/chemical properties of the substance should therefore be considered as an extreme worst case assumption and for risk assessment purposes a lower dermal absorption of e.g. 1 % might be considered more appropriate. Based on the present available data, no additional conclusion can be drawn on the distribution, metabolism and excretion of Sumilizer GS after dermal absorption.
References
1., Amidon GL. A mechanistic approach to understanding the factors affecting drug absorption: a review of fundamentals. J Clin Pharmacol 2002 Jun;42:620-43.
2. ECB EU Technical Guidance Document on Risk Assessment, 2003
3. A. Parkinson. In: Casarett and Doull's Toxicology. The basic science of poisons. Sixth edition. Ed. C.D. Klaassen. Chapter 6: Biotransformation of xenobiotics.,, 2001.
Applicant's summary and conclusion
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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