Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

Reference
Name:
bis(2-ethylhexyl) adipate
Type of composition:
legal entity composition of the substance
State / form:
liquid
Reference substance:
bis(2-ethylhexyl) adipate
PBT status:
the substance is not PBT / vPvB
Justification:

The PBT Assessment for bis(2 -ethylhexyl) adipate (DEHA, CAS 102-23-1) 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

DEHA is readily biodegradable in one study according to OECD 301F (> 90% (O2 consumption) 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

Neither DEHA nor its primary degradation products are expected to be bioaccumulative. Due to their readily biodegradable nature, extensive degradation of these substances 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, DEHA (and its metabolites) 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 DEHA by carboxylesterases into adipic acid and via 2-ethylhexanol to 2-ethylhexanoic 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 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. The supporting BCF/BAF values, estimated with the BCFBAF v3.01 program, 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 DEHA and its metabolites.

 

Toxicity

Experimental data forDEHAare available investigating the long-term toxicity to algae and invertebarates. No effects on survival and reproduction up to the solubility of the substance in water were observed for both algae and invertebrates. The available data indicate that long-term toxicity to aquatic organisms in the range of its water solubility is not to be expected. Moreover, DEHA 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 DEHA is not considered to meet the criteria to be classified as PBT or vPvB based on the available data.

Categories Display