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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 701-182-0 | 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
Ecotoxicological Summary
Administrative data
Hazard for aquatic organisms
Freshwater
- Hazard assessment conclusion:
- no hazard identified
Marine water
- Hazard assessment conclusion:
- no hazard identified
STP
- Hazard assessment conclusion:
- no hazard identified
Sediment (freshwater)
- Hazard assessment conclusion:
- no hazard identified
Sediment (marine water)
- Hazard assessment conclusion:
- no hazard identified
Hazard for air
Air
- Hazard assessment conclusion:
- no hazard identified
Hazard for terrestrial organisms
Soil
- Hazard assessment conclusion:
- no exposure of soil expected
Hazard for predators
Secondary poisoning
- Hazard assessment conclusion:
- no potential for bioaccumulation
Additional information
Studies are available for short term toxicity to Daphnia, fish and algal growth for aluminum, benzoate C16-18-fatty acids complexes (Harlan 2013), which have been read across to the registered substance. These proprietary studies were conducted as Water Accommodated Fractions (WAF) at a GLP-compliant laboratory following OECD guidelines in standard water with a hardness of approximately 150 mg/L CaCO3. No effects were seen in any of the tests at up to 100 mg/L (WAF) and the substance shows no toxicity at its limit of solubility.
Although the substance in isolated form (i.e. extracted from base oil) is considered readily biodegradable based on data read across from aluminium salts of benzoate and fatty acids C16-18 complexes, the substance tested as a 50% w.w. concentration in pharmaceutical white oil (representative of the substance in an inert carrier, typically base oil, the form in which it is marketed and used) is considered not readily biodegradable.
The substance will dissociate and degrade in the environment to CO2, H2O and, at pH7, insoluble hydrated aluminium oxide species. Equilibrium partitioning method could not be applied for this substance but while adsorption of hydrated aluminium oxide is possible, this is not expected to be hazardous as the aluminium species occur naturally in the environment.
The substance is not considered to bioaccumulate in the aquatic environment. The fatty acid components are either natural substances or chemically indistinguishable from natural substances with a long history of safe use in foods. Aluminium, with a BCF of 36 at pH 7.2 in freshwater fish, is also not expected to bioaccumulate.
The substance is not applied directly to soil and, furthermore, in realistic use scenarios, the aluminium thickener will be contained in base oil, with the formulated greases specifically designed to minimise the leaching of the thickener. Therefore, during use, the concentrations of the substance which would be released into the environment are further limited.
The substance is not expected to be bioavailable in the environment. The substance does not meet the criteria for environmental or human health classification and is not considered PBT/vPvB. As no hazard has been identified and there is no potential exposure, PNECs have not been derived.
Conclusion on classification
Based on read across, the substance is not expected to show acute toxicity to aquatic organisms at up to 100 mg/L (WAF) and therefore does not meet the criteria for classification as acutely toxic to the aquatic environment.
The substance is poorly soluble with no acute toxicity at levels up to the water solubility limit and is considered not readily biodegradable in the form in which it is marketed and used. However, it is not considered to meet the criteria for classification as chronic category 4 (the safety net classification) as it is not expected to bioaccumulate. The fatty acid components are either natural substances or chemically indistinguishable from natural substances with a long history of safe use in foods and the BCF for aluminium is 36, which is significantly below the BCF criteria of 500.
This is supported by the available data on the potential for chronic toxicity of the substance. Chronic aquatic toxicity data are only available for the structural analogue aluminium benzaoate C16-18 fatty acids complexes for algae (72 hour NOELR of 100 mg/L WAF) and these data would not result in a chronic classification.
The organic moieties of the substance, and the structural analogue Aluminum, benzoate C16-18-fatty acids complexes, are namely stearic acid, palmitic acid, benzoic acid and isopropyl alcohol (2-propanol). The organic moieties are known to have low toxicity to aquatic organisms and are not classified for the environment. Therefore, it is assumed that any potential for long-term ecotoxicity would be due to the Aluminium (Al) component of thesubstances. The available data show that, under reasonable, normal environmental conditions, Al will not cause a concern for chronic toxicity at concentrations below 74.4 μg/L. The ERGTC have generated data to show that the substance has a low water solubility of ≤ 12.5 µg/L at 20°C based on total Al concentration and, therefore, is unlikely to occur in water at concentrations high enough to cause a toxicity concern.
Furthermore, the substance is not used in isolated form but as a grease thickener within base oil. The ERGTC have conducted leaching studies in deionised water which show that, when present within a grease base, the grease thickeners are not bioaccessible. The leaching studies used a concentration of base grease (thickener in a base oil to form a grease matrix) of 1000 mg/L, with the substance being present at 50% in medicinal white oil. In the leaching studies, no Al was detected in water at the limit of detection of the analytical method of 5 µg/L. The substance would therefore not be expected to cause a concern for chronic toxicity.The screening ecotoxicity data in the leaching studies, using SPME-GC and the in vitro Microtox assay, confirm a lack of toxicity of the greases.
This substance has been registered by a Member of the European REACH Grease Thickeners Consortium (ERGTC). A number of decisions have been made in the dossier with regard to the approach taken for registering the substance including the testing strategy and the justification for waiving certain endpoints. Several of the decisions reflect the technical difficulties of testing the substance and the relevance of data with regard to the potential for exposure, given that the substance typically occurs in situ in base oil. A face to face meeting between the ERGTC and ECHA was held in Helsinki on 8th September 2016 which discussed many of these topics and a copy of the minutes from the meeting are attached to the dossier (See section 13 of IUCLID). Therefore, if there are any queries or concerns which arise when the dossier is reviewed, it is requested that the reviewer discuss these with the ERGTC (ERGTC@wca-consulting.com) as there may be background information and previously discussions between the ERGTC and ECHA available which are relevant.
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.