Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 482-480-5 | 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
Endpoint summary
Administrative data
Link to relevant study record(s)
- Endpoint:
- basic toxicokinetics, other
- Type of information:
- other: Assessment
- Study period:
- 02 July 2021
- Objective of study:
- toxicokinetics
- Conclusions:
- In conclusion, the available data show that inhalation of the substance is not a concern unless the substance were to be aerosolized intentionally into respirable droplets. Dermal absorption of the substance is unlikely. Oral bioavailability is low, as evidenced by both the acute and systemic in vivo toxicology data. Environmental concern regarding the substance is expected to be limited.
Reference
The substance is of Unknown or Variable composition, Complex reaction products or Biological materials (UVCB) with multiple constituents. The physical state of the substance is liquid. Four constituents of the substance are considered to be of primary interest; vapor pressures of these representative compounds range from 1.96E-7 to 1.40E-6 Pa at 25°C. These values provide evidence that potential inhalation of the substance due to volatilization is negligible.
The substance is essentially insoluble in water, with water solubility < 10.9 µg/mL at 25°C. The partition coefficient (Log Pow) of the material could not be determined by either the Organisation for Economic Co-operation and Development (OECD) Test Guideline (TG) 117 (HPLC Method) or OECD TG 107 (Shake Flask Method). The physicochemical property instead was calculated from the individual solubilities in n-octanol and water, and found to be 4.69, thus the substance is lipophilic. The typical molecular mass of the product is greater than 500 Daltons. When considered in light of the Lipinski Rule Oasis of the OECD Quantitative Structure–Activity Relationship (QSAR) Toolbox, the substance is considered as not bioavailable via the oral route. This is further supported by an acute oral gavage toxicity study in female rats that found no systemic effects up to 2000 mg/kg-bw, the highest dose tested. In a 28-day oral gavage repeat dose study, however, systemic effects including decreased hematocrit in female rats and decreased relative heart weight in male rats were seen in doses as low as 200 mg/kg-bw/d.
Clinical chemistry changes were noted in female rats at doses of 300 mg/kg-bw/d and higher in an OECD TG 422 study. These data suggest that the substance may be absorbed via the oral route. No information is available currently on possible degradation products produced in the gastrointestinal tract.
The extremely low water solubility, very high lipophilicity, and large molecular weight of the substance indicate that it is not expected to be absorbed via the dermal route. An acute dermal toxicity study in rats showed neither mortality nor systemic effects up to 2000 mg/kg, the highest dose tested.
So-called “PBT” characteristics (i.e., persistent, bioaccumulative, and toxic) generally are considered to determine whether a substance poses a significant concern to the environment. The substance was found to be biodegradable within 28 days, per OECD TG 301F, and readily biodegradable per the Chemical Substances Control Law of Japan. Due to the variable composition of the substance, its calculated soil adsorption coefficients (Koc), which often are used as surrogates for bioaccumulation potential, range from < 18 to 6752. The HPLC method found a Koc of 132 for the main peak of the substance, indicating high mobility in soil. There is, therefore, low potential for the substance to bioaccumulate in aquatic organisms. The substance showed low acute toxicity to algae (72-hour ErC50 of > 100 mg/L), daphnia (48-hour EC50 of 56 mg/L), and fish (96-hour LC50 of 42 mg/L) in OECD TG 289, 202, and 203 studies, respectively.
In conclusion, the available data show that inhalation of the substance is not a concern unless the substance were to be aerosolized intentionally into respirable droplets. Dermal absorption of the substance is unlikely. Oral bioavailability is low, as evidenced by both the acute and systemic in vivo toxicology data. Environmental concern regarding the substance is expected to be limited.
Description of key information
The available data show that inhalation of the substance is not a concern unless the substance were to be aerosolized intentionally into respirable droplets. Dermal absorption of the substance is unlikely. Oral bioavailability is low, as evidenced by both the acute and systemic in vivo toxicology data. Environmental concern regarding the substance is expected to be limited.
Key value for chemical safety assessment
Additional information
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.