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EC number: 275-019-2 | CAS number: 70913-98-3
- 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
Description of key information
Additional information
There are no data available investigating the terrestrial toxicity of Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3). In order to fulfil the standard information requirements set out in Annex VII, 8.5, in accordance with Annex XI, 1.5, of Regulation (EC) No 1907/2006, read-across from one structurally related substance was conducted.
In accordance with Article 13 (1) of Regulation (EC) No 1907/2006, "information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI are met.” In particular for aquatic toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, which includes the use of information from structurally related substances (grouping or read-across).
Having regard to the general rules for grouping of substances and read-across approach laid down in Annex XI, Item 1.5, of Regulation (EC) No 1907/2006 whereby substances may be predicted as similar provided that their physicochemical, toxicological and ecotoxicological properties are likely to be similar or follow a regular pattern as a result of structural similarity.
Ecotoxicological parameters for the aquatic toxicity of the target and the source substance are provided in the following table.
CAS |
70913-98-3 |
68604-38-6 |
Chemical Name |
Fatty acids, tall oil, esters with dipentaerythritol |
Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol |
MW |
1684.73 - 1840.95 |
1684.73 - 1840.95 |
|
|
|
Toxicity to soil macroorganisms except arthropods |
RA: CAS 68604-38-6 |
NOEC (56 d) ≥ 1000 mg/kg dw |
Toxicity to terrestrial arthropods |
Waiving |
-- |
Toxicity to terrestrial plants |
Waiving |
-- |
Toxicity to soil microorganisms |
Waiving |
-- |
The above mentioned substances are considered to be similar on the basis of the structural similar properties and/or activities. The available endpoint information is used to predict the same endpoints for Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3). A detailed analogue approach justification is provided in the technical dossier (see IUCLID Section 13).
Since no studies investigating the toxicity to terrestrial organisms of Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3) are available, a read across to a structurally related substance Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) was conducted in accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5. The target as well as the read-across substance are both characterised by the same fatty acid chain lengths C16, C18 and C18 unsatd. and the same alcohol component (dipentaerythritol) and are hexa-esters.
The toxicity of the read-across substance Fatty acids, C16-18 and C18-unsatd., hexaesters with dipentaerythritol (CAS 68604-38-6) to terrestrial organisms was tested in a long-term toxicity test on earthworms. Eisenia fetida was exposed to the substance in artificial soil according to OECD 222 (Hernádi, 2013). The mortality and growth of adult earthworms was assessed after 28 days and the reproduction rate after 56 days. Adverse effects of the substance were not observed and therefore a NOEC (56 d) ≥ 1000 mg/kg dw soil was determined. Studies on other terrestrial organisms are not available for Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3) but a toxicity of the substance to terrestrial organisms is considered as unlikely. Due to the low water solubility (<0.04 mg/L) and the high log Koc (7.6 - 30.72) the substance will be largely mechanically removed in conventional STPs. Only limited amounts of substance are expected to enter the secondary treatment and get in contact with activated sludge microorganisms. As a result of the high log Koc the substance is expected to be removed from the water column and will adsorb to sludge and suspended matter (Guidance on information requirements and chemical safety assessment, Chapter R.7a, (ECHA, 2012)). Nevertheless, if terrestrial organisms are exposed to the substance toxic effects are not expected as demonstrated by the available data on the acute and chronic toxicity to aquatic and terrestrial organisms. An ingestion of the substance via food particles might be possible due to the high adsorption potential. But as a result of metabolism via enzymatic hydrolysis of the substance relevant absorption and bioaccumulation is not expected. The part of Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3) that have become systemically available, might be hydrolysed and the cleavage products can be further metabolized. However, due to its high molecular weight, absorption of Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3) is not likely and thus, no extensive metabolism is expected but rather direct elimination. In conclusion, a bioaccumulation or biomagnification through the food chain of the substance is not expected. This also supported by the low BCF/BAF values (0.89 L/kg; Arnot-Gobas). For more information on metabolism please refer to IUCLID section 5.3 or Chapter 4.3 of the CSR. In summary, the substance is unlikely to pose a risk for terrestrial organisms based on 1) the lack of exposure and 2) the low toxicity of the substance for terrestrial organisms indicated by the available experimental data, metabolism considerations and the lack of adverse effects in aquatic ecotoxicity tests. As it can be seen in the data matrix of the analogue justification in IUCLID Section 13, all reliable data from the target and the source substance support the read-across for the endpoint long-term toxicity to aquatic invertebrates by showing a consistent pattern of results.
References
ECHA. 2012. Guidance on information requirements and chemical safety assessment – Chapter 7a: Endpoint specific guidance.European Chemicals Agency, Helsinki.
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