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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 232-445-3 | CAS number: 8030-70-4
- 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
Bioaccumulation: terrestrial
Administrative data
Link to relevant study record(s)
Description of key information
The assessment entity “tall oil” is a mixture of different saturated and unsaturated C16 -C18 fatty acids. Therefore, the endpoint is addressed with publicly available data on fatty acids with the same or similar structure, including conservatively fatty acids with a shorter chain (i.e. C14) if relevant and appropriate in accordance with previously applied read-across approaches (U.S. EPA Fact Sheet, 2008).
A registration dossier shall contain information on the environmental hazard assessment (Regulation 1907/2006, Article 10). For the environmental hazard assessment of tall oil, the standard testing regime set out in Annexes VII to IX is adapted in accordance with Section 1.2 and 1.3 of Annex XI so that “testing does not appear to be scientifically necessary” as follows:
(I) The ecotoxic potential of the fatty acid (tall oil) is assumed to be negligible. Fatty acids are generally not considered to represent a risk to the environment, which is reflected in their exemption from the obligation to register (Annex V, Section 9 and Regulation (EC) No 987/2008).
(II) Fatty acids will rapidly be degraded in soil by the β-oxidation pathway (e.g. essential process in the citric acid cycle) and thus, tall oil is not expected to accumulate in the soil (EU RAR zinc distearate, 2008).
(II) Based on reviews of HERA (2003) and OECD SIDS (2014), the water solubility of fatty acids seems to generally decrease with increasing chain length whereas the octanol-water partition coefficient log Kow seems to increase. Estimated bioconcentration factors (BCF) of aliphatic acids calculated using EPI Suite v4.10 are below 100 indicating a low potential for bioaccumulation OECD SIDS (2014). This is mainly attributable to the fact that fatty acids are readily biodegradable in the environment and will rapidly be degraded in the animal body by the β-oxidation pathway (e.g. essential process in the citric acid cycle). Hence, fatty acids are not expected to bioaccumulate (EU RAR zinc distearate, 2008).
(III) BCF values (BCFBAF v3.01; EPI Suite v4.1; regression-based log BCF estimates) were estimated for tall oil based on QSAR taking into account its major components, oleic and linoleic acid (C18 fatty acids) as well as palmitric acid (C16 fatty acid). Based on experimental log Kow values (amounting to 7.64, 7.05 and 7.17 for oleic, linoleic and palmitric acid, respectively), a regression-based log BCF of 1.75 L/kg (corresponding to a BCF of 56.2 L/kg) was estimated for each of the three fatty acids.
In summary, QSAR-based estimates and a ready biodegradability indicate a low bioaccumulation potential for C16-18 fatty acids. Thus, performing further bioaccumulation tests of tall oil is from a scientific point of view not expected to provide more insight into the environmental fate and is not considered necessary for the environmental hazard assessment.
References:
U.S. Environmental Protection Agency, U.S. EPA (2008). Ammonium nonanoate (031802) Fact Sheet, OPP Chemical Code: 031802, p. 2
OECD SIDS initial assessment profile- aliphatic acids (2014), CoCAM 6 September 30-October 3, Italy/ICCA, p. 41
HERA (2003). Human & Environmental Risk Assessment on ingredients of European household cleaning products. Fatty Acid Salts (Soap) Environmental Risk Assessment
EU Risk Assessment Report, RAR - Zinc distearate (2008), CAS No. 557-05-1 & 91051-01-3. PART 1 Environment, p. 63
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.