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EC number: 203-372-4 | CAS number: 106-20-7
- 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: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
Accumulation in organisms is possible.
Key value for chemical safety assessment
Additional information
Quantities of non-intermediate uses are below 100 t/yr. Hence, additional standard information requirements according to Annex IX and Annex X are not to be fulfilled.
However, data will be provided in order to discuss the bioaccumulation potential within the PBT assessment.
QSAR-disclaimer
In Article 13 of Regulation (EC) No 1907/2006, it is laid down that information on intrinsic properties of substances may be generated by means other than tests, provided that the conditions set out in Annex XI (of the same Regulation) are met. Furthermore according to Article 25 of the same Regulation testing on vertebrate animals shall be undertaken only as a last resort.
According to Annex XI of Regulation (EC) No 1907/2006 (Q)SAR results can be used if (1) the scientific validity of the (Q)SAR model has been established, (2) the substance falls within the applicability domain of the (Q)SAR model, (3) the results are adequate for the purpose of classification and labeling and/or risk assessment and (4) adequate and reliable documentation of the applied method is provided.
For the assessment of (CAS 106-20-7) (Q)SAR results were used for aquatic bioaccumulation. The criteria listed in Annex XI of Regulation (EC) No 1907/2006 are considered to be adequately fulfilled and therefore the endpoint(s) sufficiently covered and suitable for risk assessment.
Therefore, and for reasons of animal welfare, further experimental studies on aquatic bioaccumulation are not provided.
Results and assessment of bioaccumulation
The log Kow of the substance was measured to be 7.3 at 25 °C and pH 7.5 (Oxea AN-ASB 0496, 2010), indicating a potential for bioaccumulation.
Experimental data on bioaccumulation are not available for di-(2-ethylhexyl)amine (CAS 106-20-7). However, in order to assess the bioaccumulation potential of the substance, the BCF was calculated with the Catalogic estimation model provided by OASIS. The table below lists the applied (Q)SAR models, the estimated BCF values and basic information on the applicability domain (AD). Detailed information on the model’s results and the AD are given in the endpoint study records of IUCLID Chapter 5.3.1. The selected models comply with the OECD principles for (Q)SAR models.
Summary of relevant information on aquatic bioaccumulation of the substance: Predicted BCF values for applied QSAR models sorted in ascending order by BCF (AD = Applicability Domain)
Model |
BCF [L/kg] |
In AD |
Restraints |
BCF base-line model v04.11 (OASIS Catalogic v5.14.1.5): incl. mitigating factors |
562 |
yes |
Mainly metabolism and molecular size are the effective mitigating factors for the Substance. The substance is completely within the applicability domain of the model (parametric, structural, metabolic). |
BCF base-line model v04.11 (OASIS Catalogic v5.14.1.5): not considering mitigating factors |
22131 (max. BCF) |
yes |
This BCF value is given only as a reference value as it was calculated without considering any mitigating factors. The assessment of the bioaccumulation potential should be based on the BCF value considering all mitigating factors. |
The BCF base-line model v04.11 (OASIS Catalogic v5.14.1.5) takes several mitigating factors into consideration in the calculation of the bioaccumulation potential. The model calculated a BCF of 562 L/kg when considering mitigating factors like metabolism, molecular size and water solubility. Metabolism had the highest mitigating effect on the bioaccumulation potential, followed by molecular size and, to a minor extent, water solubility. According to the OECD 305 technical guidance document, the degree of transformation of the parent is decisive for the effect of metabolism (i.e. the reproduction of subsequent steps is less critical for the prediction of the BCF). The BCF base-line model identified aliphatic N-oxidation as the relevant phase I reaction for the substance. Further identified transformations are aliphatic C-hydroxylation, N-dealkylation, and omega oxidation. Without these mitigating factors, a BCF of 22131 was calculated. However, this value is not relevant for the assessment of the bioaccumulation potential as the relevant mitigating factors were not considered. This maximum BCF is a theoretical bioconcentration factor for a given log Kow value assuming that the only driving force of bioconcentration is lipophilicity and the effect of any other factors is insignificant.
Molecular size and water solubility are discussed within the literature whether certain threshold values are suitable as cut-off criteria for indication of limited bioaccumulation. Regarding molecular size, the PBT working group on hazardous substances discussed a maximum diameter of > 17.4 Å (Comber et al., 2006). The average diameter of the molecules is slightly lower, but the maximum diameter exceeds this critical value; therefore, the bioaccumulation potential of the Substance is reduced as the molecules would pass less easily through cell membranes.
Conclusion
Summing up the available estimated data on the bioaccumulation potential of di-(2-ethylhexyl)amine (CAS 106-20-7), it can be concluded that accumulation in organisms is possible. However, taking into consideration mitigation factors like metabolism by organisms and molecular size, the substance does not fulfill the B criterion in the PBT assessment as the relevant BCF is < 2000 L/kg (see IUCLID Ch. 2.3).
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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