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EC number: 203-091-7 | CAS number: 103-24-2
- 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
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Toxicity to soil macroorganisms except arthropods
Administrative data
Link to relevant study record(s)
Description of key information
In accordance with Annex IX, column 2 (9.4) of Regulation (EC) No. 1907/2006, testing for toxicity to soil macroorganisms is not required since direct and indirect exposure of the soil compartment is unlikely. Furthermore, Bis(2-ethylhexyl) azelate is unlikely to pose a risk for terrestrial organisms considering the low toxicity as expected for this substance. Therefore, no tests on terrestrial macroorganisms are provided.
Key value for chemical safety assessment
Additional information
In accordance with Annex IX, column 2 (9.4) of Regulation (EC) No. 1907/2006, testing for toxicity to terrestrial organisms is not required since direct and indirect exposure of the soil compartment is unlikely. Furthermore, considering all available related data combined in an expert statement as presented below, all members of the PFAE linear are unlikely to pose a risk to terrestrial organisms.
Intrinsic properties and fate/ exposure
All members of the PFAE linear category are readily biodegradable. According to the Guidance on information requirements and chemical safety assessment, Chapter R.7b, readily biodegradable substances can be expected to undergo rapid and ultimate degradation in most environments, including biological Sewage Treatment Plants (STPs) (ECHA, 2012b). If direct/indirect application of these substances occurs (indirect via sludge application) the substances will again be rapidly degraded until ultimate biodegradation. In addition, for some category member direct and indirect exposure to soil can be excluded (see table above).
Aquatic and terrestrial ecotoxicity data
The PFAE linear is a robust category with sufficient experimental data for the aquatic toxicity covering acid carbon numbers from C6 to C10 and total carbon numbers ranging from C10 to C38. Short-term aquatic toxicity data is available for all trophic levels within the PFAE linear category. Long-term data is available for aquatic invertebrates and algae. Based on the experimental data, the majority of category members exhibit no acute and chronic toxicity to aquatic organisms. Only two ester with Adipic acid (C6) as dicarboxylic acid component and short chain alcohols, are supposed exhibit toxicological effects (CAS 105-99-7, Dibutyl adipate and CAS 6938-94-9, Diisopropyl adipate) to aquatic organisms. Nevertheless, the absence of chronic or long-term toxicological effects in aquatic organisms up to the substance solubility limit, can, as ECHAs Guidance R.7c states, can be used as part of a Weight of Evidence argument to modify/waive the data requirements of Annex IX and X. There are three chronic tests on aquatic invertebrates available for insoluble category members (i.e. CAS 103-23-1 Bis(2-ethylhexyl) adipate; CAS 33703-08-1 Diisononyl adipate and CAS 103-24-2 Bis(2-ethylhexyl) azelate. These substances exhibit log Kow values > 5 and a water solubility < 0.05 mg/L. In none of these tests effects on Daphnia were observed in nominal concentrations well above the limit of water solubility. This result is also supported by algal toxicity data where either all NOEC´s are above 1mg/L or where no toxicity was observed within the water solubility. Therefore, it is assumed that due to the lack of chronic aquatic toxicity, long term tests on terrestrial organisms will not result in a different outcome. Therefore no chronic tests for terrestrial organisms are either provided, or deemed as necessary for the chemical safety assessment.
For the assessment of terrestrial toxicity three studies investigating the acute toxicity to earthworm are available for the category PFAE linear, covering “poorly or insoluble” members (i.e Bis(2-ethylhexyl) adipate CAS 103-23-1 and Bis(tridecyl) adipate CAS 16958-92-2) to “water soluble” members (i.e. Dibutyl adipate CAS 105-99-7). The results of all tests show LC50 values well above 100 mg/kg soil dw for Eisenia fetida.
Available reliable data for toxicity to aquatic microorganisms for the PFAE linear category members support the assumption of a lack of toxicity to soil organisms, including soil microorganisms. No inhibition of respiration rate of aquatic microorganisms was observed in any of the available studies for the PFAE linear members. The Guidance Document (ECHA, 2012) states that a test on soil microbial activity will only be additionally necessary for a valid PNEC derivation if inhibition of sewage sludge microbial activity has occurred and this is clearly not the case.
Metabolisms/Bioaccumulation
After absorption, members of the PFAE linear category are expected to be enzymatically hydrolysed in vivo by the ubiquitary enzyme carboxylesterase, yielding the corresponding alcohols and acid. QSAR estimations using BCFBAF v3.0 support the expected rapid biotransformation of this substance with BCF/BAF values of < 29 L/kg, respectively (Arnot-Gobas estimation including biotransformation, upper trophic level).
The metabolism of the hydrolysis products: alcohol (e.g. Isopropanol) and dicarboxylic acid (e.g. Adipic acid) is well established and not of concern in terms of bioaccumulation (for further information see chapter 5.3 of the technical dossier).
Conclusion
All members of the category PFAE linear are unlikely to pose a risk for terrestrial organisms based on a) the lack of chronic exposure due the ready biodegradation, b) the absence of bioaccumulation potential and c) the low toxicity as expected for this substance for terrestrial organisms based on metabolism considerations and available short term tests to earthworm. In addition available use information on this substance clearly indicates that no direct and indirect exposure of the soil compartment occurs. Taking all the available information into account toxicological effects on soil organisms are thus not expected to be of concern, and consequently, in accordance with Regulation (EC) No. 1907/2006, Annex X, Column 2, 9.4 further studies on the effects on terrestrial organisms do not have to be conducted since the chemical safety assessment indicates that there is no need.
A detailed reference list is provided in the technical dossier (see IUCLID, section 13) and within CSR.
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.
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