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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
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EC number: 604-612-4 | CAS number: 147900-93-4
- 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 from an internationally recognized contract research organization. This expert statement has been based on a series of physicochemical and toxicology studies with WS400151 or a formulation of it, 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:
- 2 011
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 and toxicology studies with WS400151 or a formulation of it. 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: WS400151 or a formulation of it
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 vitro and 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 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 in-vivo 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:
- The test material, WS400151, is a complex mixture of components. The low water solubility (< 1 mg/L at 20°C), the high lipophilicity (Log10Pow > 5.7 at 20°C) and to some extent the molecular weight (ca. 280 – 810) of WS400151 would be expected to limit its rate of transfer between the stratum corneum and the lower epidermis and dermis after topical administration, and to limit its absorption after oral administration [ECHA, Chapter R.7c: Endpoint specific guidance]. Consequently the above physicochemical properties of WS400151 are considered to limit its systemic availability both, after topical and after oral administration. This is consistent with the absence of any signs of absorption or of relevant skin irritation in the available toxicity studies with WS400151, except the sensitization response attained in a Local Lymph Node Assay (LLNA) in mice at non-irritating test concentrations of WS400151. Therefore, in the latter study some dermal absorption must have occurred, although this may have been only a small fraction of the administered test material.
Inhalation exposure to WS400151 is unlikely, because it has a very low vapour pressure (5 x 10E-3 Pa at 25°C) limiting its availability under a vapour state, and because it is a highly viscous liquid limiting its availability as an inhalable aerosol. - Details on distribution in tissues:
- There is no indication in the available study results regarding the metabolism or distribution of WS400151 or components thereof.
- Details on excretion:
- There is no indication in the available study results regarding the excretion of WS400151 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
Systemic availability of WS400151 after topical or oral administration is expected to be limited, because of its low water solubility, high lipohilicity and to some extent its molecular weight (ca. 280 – 810). However, some dermal absorption of WS400151 or of a fraction of this complex mixture has been concluded from the sensitization response attained in a Local Lymph Node Assay (LLNA) in mice at non-irritating test concentrations.
Availability of WS400151 under a vapour state is unlikely, because of its low vapour pressure, and its availability as an inhalable aerosol is unlikely, because it is a highly viscous liquid.
All available study results gave no indication regarding the metabolic pathway, distribution or excretion of WS400151 or its bioaccumulation potential.
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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