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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 903-161-3 | 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)
Description of key information
Short description of key information on bioaccumulation potential result:
An assessment of the toxicokinetic behaviour of the substance has been conducted to the extent that can be derived from relevant available information.
Key value for chemical safety assessment
- Bioaccumulation potential:
- low bioaccumulation potential
Additional information
TEST MATERIAL
The substance is solid in it's pure form, however all testing has been conducted on a sample of the neat substance with refined mineral oil (approx 60% EC 903-161 -3 and 40% refined mineral oil). This was deemed the most appropriate sample to test as the material will be exclusively present in solvent oil during synthesis and handling.
TOXICOKINETICS ASSESSMENT
There were no toxicokinetic studies that directly addressed absorption, distribution, metabolism, or excretion of EC-903 -161 -3. However, information is available from existing toxicology studies and the physical chemical properties to infer potential toxicokinetic properties.
Significance of Route of Exposure
Dermal route: This is considered the principle route for occupational exposure.
Oral route: This is not considered a relevant route for occupational exposure or the general population. Slight exposure may occur via accidental hand-to-mouth contact, but this isn’t expected to contribute significantly to exposure.
Inhalation route: Under conditions of normal handling and use, the registered substance will not be aerosolized and, based on its physico-chemical properties, there is negligible potential for volatilisation and inhalation exposure.
ABSORPTION
Dermal route: According to ECETOC Monograph 20: Percutaneous Absorption, the physical chemical properties that influence dermal absorption are molecular weight, water and lipid solubility, and degree of ionization. The molecular weight of the substance is variable given that it is a UVCB; however, it is expected the majority of components will be larger than 500 g/mole, which is the generally accepted limit for size exclusion by the skin.
EC 903-161-3 is very lipophilic, with a log Kow>6.33. Maximum absorption is generally between log Kow1 and 2 and therefore the substance is too lipophilic to be readily absorbed. This is because the penetrant has to be lipophilic enough to cross the lipophilic portion of the membrane, but hydrophilic enough to pass the hydrophilic portion.The water solubility of this substance is approximately <0.5 mg/L. This indicates that the Registration substance is likely to have very low solubility in water, thus further decreasing the potential for complete penetration. The material is exclusively synthesised and handled in base oil, it is considered the material will preferentially remain within this solvent and is unlikely to favour partitioning into the stratum corneum. Based on these physical chemical properties, this material is predicted to be absorbed very slowly and no significant systemic uptake is expected.
An acute dermal study conducted on EC-903-161-3 did not show any evidence that the material was dermally absorbed as no signs of toxicity were seen in any aspect of the study. The Local Lymph Node Assay on material EC 903-161-3 was negative, but the results suggest that some test material or component may be getting absorbed through the skin.
Oral Route: The same physical and chemical factors that affect dermal absorption also affect absorption from the gastrointestinal (GI) tract. The difference being that log Kow between 0 and 4 are optimal for GI absorption. The high lipophilicity, low water solubility, and large molecular weight of the registered substance are not favourable for GI absorption. However it is possible that a very small percentage of components of the UVCB registration material maybe of low enough molecular weight to favour absorption across the GI tract. Results obtained from acute animal toxicity tests in which the Registration substance was administered via oral gavage and in which acute toxicity was not observed (i.e., LD50s were greater than 2000 mg/kg) provide no evidence of significant absorption across the GI tract. A sub-acute study conducted on the Registration substance showed a low order of toxicity (i.e., minimal effects at 1000 mg/kg/day), again providing no evidence of significant absorption across the GI tract.
DISTRIBUTION
Some of the factors that affect absorption will also affect the distribution of chemicals within the body. In general, the more lipophilic the substance, the more readily it will move into the tissues, especially fatty tissues and the more highly perfused tissues such as heart, liver and kidney. Plasma protein binding can influence the movement of chemicals from blood to tissue; however no information on the materials ability to bind to plasma proteins is available. No tissue effects were seen in any of the in vivo studies conducted therefore it is not clear whether EC 903-161-3 is absorbed and whether it partitions into any specific tissues.
METABOLISM
The results of the sub-acute 28-day oral toxicity study show no evidence of an adaptive response in the livers of rats, which is normally associated with enhanced metabolism. The results of the in vitro genotoxicity assays do not show any evidence that addition of the S9 metabolising system either enhances or diminishes the activity of the substance and therefore does not give any indication as to whether the material is metabolised. It was not possible to ascertain the hydrolytic stability of the material as it is of very low water solubility. However, approximately 21% degradation occurred over 28 days in the ready biodegradation study, and this was attributed to both biotic and abiotic degradation. Therefore, no data exist to suggest that EC 903-161-3 is significantly metabolised within the body.
EXCRETION
There is no data to indicate the main route of excretion but poorly water soluble products with high molecular weight are unlikely to be excreted in the urine. Therefore, if material is absorbed and is not extensively metabolised biliary excretion may be a significant route for this material. Any test material that is not absorbed will be excreted in the faeces.
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.