Registration Dossier

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

Currently viewing:

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

The PBT assessment of Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

 

Persistence

Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) is readily biodegradable (76 – 81% within 28 d, 301 B, activated sludge, RA CAS 85049 -37-2 and 26399-02-0). Thus, the substance does not meet the screening criterion for persistency and is not considered to be P or vP.

 

Bioaccumulation

Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) has a high log Kow (> 10.0) indicating a potential for bioaccumulation. However, due to the low water solubility, rapid environmental biodegradation and metabolization via enzymatic hydrolysis a relevant uptake and bioaccumulation in aquatic organisms is not expected. Enzymatic breakdown will initially lead to the free fatty acid and the free alcohol. From literature it is well known that these hydrolysis products will be effectively metabolized and excreted in fish (Heymann, 1980; Lech & Bend, 1980; Lech & Melancon, 1980; Murphy & Lutenske, 1990; Sand et al., 1973). Thus, taking all information into account, the substance is not considered to be B or vB.

 

Toxicity

Neither long-term toxicity tests with aquatic invertebrates and algae nor short-term toxicity tests with aquatic organisms from all three trophic levels showed any effects up to the limit of water solubility. Moreover, Fatty acids, C16-18, isononyl esters (CAS 91031-57-1) is not classified according to Regulation (EC) No. 1272/2008 and the following amendments (ATPs). 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.

 

In conclusion the substance is not PBT/vPvB.