Registration Dossier
Registration Dossier
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EC number: 251-646-7 | CAS number: 33703-08-1
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Diisononyl adipate (DINA, CAS 33703-08-1) 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
DINA 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
DINA 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, DINA (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 DINA by carboxylesterases into adipic acid and isononanol 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 for the suitable read across substance DEHA 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 EPISuite and Catalogic models, 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 DINA and its metabolites
Toxicity
Experimental data investigating the long-term toxicity to algae and invertebrates are available for DINA and the suitable read across substance Bis(2-ethylhexyl) adipate (CAS 103-23-1), respectively. No effects on survival and reproduction up to the solubility of the substances 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, DINA 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 DINA is not considered to meet the criteria to be classified as PBT or vPvB based on the available data.
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