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Diss Factsheets
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EC number: 262-979-2 | CAS number: 61788-48-5
- 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
The substance is expected to undergo hydrolysis and metabolism but, considering the lack of acute (oral or dermal) or repeat dose toxicity, it is unlikely that metabolites of the registered substance present an additional toxicological hazard.
Key value for chemical safety assessment
- Bioaccumulation potential:
- no bioaccumulation potential
Additional information
No specific toxicokinetic (TK) investigations, or potential metabolite studies, were available at the time of review. However, a substantive volume of physical chemical and toxicity data exits from which a reasoned scientific opinion on the TK parameters (absorption, distribution, metabolism and excretion) of this substance may be derived.
The physio-chemical data demonstrate that this substance (a UVCB) is sparingly soluble in water (< 1.0E-03 g C/L at 20.0 ± 0.5 °C), highly lipophilic (partition coefficient: > 1.0E10, Log10 Pow > 10) and has a low vapour pressure (1.27E-02 Pa at 25 °C). These data strongly suggest that absorption of this substance via the GI tract and skin are likely to be significant. However, inhalation exposure (particle size not relevant) is unlikely to be either an issue or a major route of exposure and therefore of limited concern regarding significant systemic exposure. The data indicate that the substance may have the potential to be widely distributed in the body but have a limited potential for accumulation. Furthermore, the chemistry and physical chemical properties suggest that the substance is likely to undergo extensive metabolism, the liver and kidneys being the most likely major sites. As a result, it may be expected that excretion would be most likely via the urine and to a lesser extent in the faeces.
The substance will hydrolyse in the gut of organisms resulting in the original fatty acid or alcohol structures and their metabolites being produced. As a result, the lanolin fatty acids and lanolin alcohols are the substances representative of what will be available in humans and a read-across from these substances can thus be used to determine the potential toxicity of lanolin acetate. Based on this read-across, the substance is of remarkably low toxicity both acutely (oral or dermal, LD50 > 2000 mg/kg) or after repeat oral dosing (F0 systemic and reproductive, and F1 neonatal NOAEL≥1000 mg/kg bw/day). It is neither genotoxic nor a skin or eye irritant, and was shown not to be a skin sensitiser. As stated, the physio-chemical data suggest significant potential for both oral and dermal absorption and therefore systemic exposure. Exposure to the parent substance, and subsequent metabolism and metabolites was without obvious adverse toxicological consequences (e.g. no in vitro genotoxicity was seen presence of metabolic activation). As it may be reasonably anticipated that the hydrolysis products of the substance undergo metabolism, and considering the lack of acute (oral or dermal) or repeat dose toxicity, it is likely that metabolites of this substance do not present an additional toxicological hazard.
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.
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