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Diss Factsheets
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EC number: 292-835-4 | CAS number: 91001-64-8
- 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: expert statement
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well documented expert statement based on a series of physicochemical, environmental and toxicology studies with WS400109 in general performed according to technical guidelines and in compliance with GLP in internationally recognized contract research organizations.
Cross-reference
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
- Objective of study:
- absorption
Test guideline
- Qualifier:
- no guideline required
- Principles of method if other than guideline:
- Expert statement based on a series of physicochemical, environmental and toxicology studies with WS400109. Technical guidelines followed in these experimental studies are cited in the respective endpoint study records.
- GLP compliance:
- no
- Remarks:
- Considered unnecessary for expert statement
Test material
- Details on test material:
- - Name of test material: WS400109
Further details on the test material used in the experimental studies referred to are presented in the respective endpoint study records.
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: Detailed in endpoint study records of in-vivo studies referred to in the present expert statement
- Strain:
- other: Detailed in endpoint study records of in-vivo studies referred to in the present expert statement
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- Detailed in the endpoint study records of in-vivo studies referred to in the present expert statement.
Administration / exposure
- Route of administration:
- other: Detailed in endpoint study records of in-vivo studies referred to in the present expert statement
- Vehicle:
- other: Detailed in endpoint study records of in-vivo studies referred to in the present expert statement, if appropriate
- Details on exposure:
- Detailed in endpoint study records of in-vivo studies referred to in the present expert statement.
- Duration and frequency of treatment / exposure:
- Detailed in endpoint study records referred to in the present expert statement.
Doses / concentrations
- Remarks:
- Doses / Concentrations:
Detailed in endpoint study records of in-vivo studies referred to in the present expert statement.
- No. of animals per sex per dose / concentration:
- Detailed in endpoint study records of in-vivo studies referred to in the present expert statement.
- Control animals:
- other: Detailed in endpoint study records referred to in the present expert statement, if applicable
- Positive control reference chemical:
- Detailed in endpoint study records referred to in the present expert statement, if applicable
- Details on study design:
- Detailed in endpoint study records referred to in the present expert statement, if applicable
- Details on dosing and sampling:
- Detailed in endpoint study records referred to in the present expert statement, if applicable
- Statistics:
- Detailed in endpoint study records referred to in the present expert statement, if applicable. Not applicable for the present expert statement.
Results and discussion
- Preliminary studies:
- Not applicable
Toxicokinetic / pharmacokinetic studies
- Details on absorption:
- Moderate partition coefficient values (Log10Pow ≥ -1 ≤ 4) with molecular weights < 500 are favourable for gastrointestinal absorption [ECHA 2008]. The test material, WS400109, is a complex mixture of components and a number of its components (ca. 80% by chromatographic area) have a Log10Pow > 4.1 at 25°C. In general, its molecular weight range is ca. 370-900, but for ca. 3.7% of it a molecular weight of ca. 100 has been identified. The water solubility of WS400109 is < 1 mg/L at 20°C (pH 4.9 - 6.5). Therefore, in general, absorption of WS400109 after oral uptake is expected to be limited, but in view of the above partition coefficient data and some of the components with a molecular weight < 500, some gastro-intestinal absorption of WS400109 or components thereof after oral uptake cannot be entirely discounted. After repeated oral gavage administration of WS400109 for 5 weeks to male and female rats, a number of haematology and biochemical blood plasma parameters differed statistically significantly from concurrent controls, but these changes were toxicologically irrelevant and it has remained unclear, whether or not they reflect systemic absorption of WS400109 or components of it.
After topical administration to intact skin, the transfer of WS400109 from the stratum corneum to the lower epidermis and dermis is expected to be limited, because of its low water solubility and to some extent the molecular weight [ECHA 2008]. However, some dermal absorption of WS400109 or a fraction of it must have occurred in a Local Lymph Node Assay (LLNA) with mice, because topical administration of undiluted WS400109 to the ears caused increases in ear thickness (> 25%) and of non-irritating test concentrations a dose-related sensitization response.
No data is available on absorption after inhalation. Inhalation of any vapour from WS400109 is an unlikely route of human exposure, because the substance has a very low vapour pressure (7 x 10E-3 Pa at 25°C) and decomposes without boiling at high temperatures (> ca. 215°C) [ECHA 2008]. Exposure of humans to an inhalable aerosol of WS400109 may be unlikely, because it is a viscous liquid (viscosity medium in degree) probably limiting its availability as an inhalable aerosol.
Reference: ECHA 2008, Chapter R.7c: Endpoint specific guidance - Details on distribution in tissues:
- There is no indication in the available study results regarding the metabolism or distribution of WS400109 or components thereof.
- Details on excretion:
- There is no indication in the available study results regarding the excretion of WS400109 or components thereof.
Metabolite characterisation studies
- Metabolites identified:
- not specified
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): bioaccumulation potential cannot be judged based on study results
No specific study was performed on the absorption, distribution, metabolism and/or excretion (ADME) of WS400109. In general, absorption and systemic availability of WS400109 after oral or topical administration are expected to be limited, because of its low water solubility (< 1 mg/L), rather high lipohilicity (for ca. 80% by chromatographic area Log10Pow > 4.1) and, to some extent, its molecular weight (ca. 370 – 900). However, some absorption and systemic availability of WS400109 or components of this complex mixture cannot be entirely discounted, because a number of its components may have a partition coefficient value (Log10Pow) ≤ 4.1 and/or for some the molecular weight is only moderate, i.e. ca. 100 or ca. 370 to < 500.
Effects clearly indicative of absorption and systemic availability of WS400109, components or metabolites of it have not been evident after oral administration to rodents in the available toxicity studies. However, some dermal absorption of WS400109 or a fraction of it after topical administration has been concluded from an irritation response (increased ear thickness) to undiluted WS400109 and from a dose-related sensitization response to non-irritating test concentrations attained in a Local Lymph Node Assay (LLNA) in mice.
Availability of WS400109 under a vapour state is unlikely, because of its low vapour pressure and decomposition without boiling (above ca. 215°C), and its availability as an inhalable aerosol may be unlikely, because it is a viscous liquid.
All available study results gave no indication regarding the metabolic pathway, distribution or excretion of WS400109. Bioaccumulation was not investigated.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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