Registration Dossier
Registration Dossier
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EC number: 940-510-9 | CAS number: 103043-58-9
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Bis(2-propylheptyl) hexanedioate (DPHA) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).
Persistence
DPHA is readily biodegradable in one study according to OECD 301B (90 - 100% (CO2 evolution) after 28 d). Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be P or vP.
Bioaccumulation
DPHA is not expected to be bioaccumulative. Due to their readily biodegradable nature, extensive degradation of the substance in conventional STPs will take place and only low concentrations are expected to be released into the environment. Once present in the aquatic compartment, further biodegradation will occur and, depending on their log Pow, water solubility and adsorption potential, DPHA will be bioavailable to aquatic organisms such as fish mainly via water or on the other hand via feed and contact with suspended organic particles. After uptake by fish species, extensive and fast biotransformation of DPHA by carboxylesterases into adipic acid and via 2-propylheptanol to 2-propylheptanoic acid is expected. The alcohol is used by these organisms as their main source of energy throughout all the different life stages (early development, growth, reproduction, etc.). Adipic acid does not have the potential to accumulate in adipose tissue due to their low log Pow. The key study with the read across substance reports a BCF value of 27, which clearly indicate that rapid metabolism takes place even when log Pow values are above the trigger value of 4.5. Supporting BCF/BAF values estimated using BCFBAF v3.01 confirm the experimental result (all well below 2000). The information above provides strong evidence supporting the statement that rapid metabolism and low bioaccumulation potential can be expected for DPHA and its metabolites.
Toxicity
Experimental data forDPHAare available investigating the long-term toxicity to algae, fish and invertebrates. No effects on survival and reproduction up to the solubility of the substance in water were observed for all trophic levels. The available data indicate that long-term toxicity to aquatic organisms in the range of its water solubility is not to be expected. Moreover, DPHA is not classified according to Directive 67/548/EEC and Regulation (EC) No. 1272/2008. Thus, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and the test substance is not considered to meet the T criterion.
Conclusion
In conclusion DPHA is not considered to meet the criteria to be classified as PBT or vPvB based on the available data.
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