Reaction mass of Pentaerythritol bis (2-ethylhexanoate) bis (3,5,5-trimethylhexanoate) and Pentaerythritol tris (2-ethylhexanoate) 3,5,5-trimethylhexanoate and Pentaerythritol 2-ethylhexanoate tris (3,5,5-trimethylhexanoate) and Pentaeryhthritol tetrakis(2-ethylhexanoate) and Pentaerythritol tetrakis (3,5,5-trimethylhexanoate)

PBT assessment

PBT assessment: overall result

Reference

Name:

Reaction mass (EC 415-650-4)

Type of composition:

boundary composition of the substance

State / form:

liquid

Reference substance:

Reaction mass (EC 415-650-4)

Reference substance:

Reaction mass (EC 415-650-4)

Reference substance:

Reaction mass (EC 415-650-4)

Reference substance:

Reaction mass (EC 415-650-4)

Reference substance:

Reaction mass (EC 415-650-4)

PBT status:

the substance is not PBT / vPvB

Justification:

P/vP: In a study performed according to OECD 301B it was determined that the substance is not readily biodegradable. Based on this information alone, no definitive conclusion on P/vP can be reached.

B/vB: At very high log Pow, the linear relationship between log BCF and log Pow is not valid. For superlipophilic substances the BCF decreases with increasing log Pow due to limited bioavailability. For substances with a log Pow higher than 10, it is most probably that the aquatic BCF is lower than 2000 L/kg. The calculated log Pow values of the constituents are 12.34 - 13.86. As stated in IR/CSR Guidance R.7c (Section R.7.10.3.4), a calculated log Pow ≥10 is taken as an indicator of reduced bioconcentration. Calculated BCF values for the constituents are indeed low (0.9 - 32.1 L/kg) and far below the criterion of 2000. Moreover, the maximum diameter (Dmax) of the smallest constituent could not be calculated using the OASIS software module incorporated in the OECD QSAR Toolbox, because its SMILES notation was too lengthy. Also demonstrating that the constituents will not pass through the cell membranes. Furthermore, based on the very poor (calculated) water solubilities of the constituents, together with their relatively high molecular weight, it can be deemed acceptable that the bioavailability and thus the bioaccumulation of the substance will be low. Based on these arguments, the substance is considered as not B/vB.

T: In acute tests with 3 trophic levels, no effects were observed at the maximum solubility of the test substance in medium. No chronic effects were observed in a study with algae. Furthermore, the substance is not classified as carcinogen, mutagenic or toxic for reproduction (CMR) and there is no other evidence of chronic toxicity (STOT RE). However, as only one chronic study is available (algae), no definitive conclusion on T can be reached.