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PBT assessment

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PBT assessment: overall result

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

The PBT assessment for Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2017).

Persistency assessment

Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) is not readily biodegradable. A degradation rate of 7.6% (CO2 evolution) was determined in a study according to OECD 301B. Thus, the substance is considered to be P and vP. 

Bioaccumulation

Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) is characterized by a low water solubility (< 1.7E-4 mg/L), high log Kow (> 10) and high molecular weight (1853.05 g/mol). In accordance with the guidance document R.11 (ECHA, 2017) the screening criterion for a potential accumulation in water (log Kow > 4.5) is met. However, further evidence clearly indicates that the substance has a limit potential for bioaccumulation in aquatic organisms.
The uptake of the substance by adsorbtion is considered to be very limited due to sterical hindrance to cross biological membranes. A log Kow of > 10 (15.68 - 48.16) in combination with no toxicity in mammalian toxicity studies are considered as indicators for a limited potential for absorption. A potential for absorption of the substance is further limited by the high molecular weight (1853.05 g/mol). In addition it is clearly stated within the guidance document R.11 that substances with a log Kow > 10 are unlikely to meet the B-criterion.

It can be concluded that the bioaccumulation potential of Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] is negligible.

Toxicity

Octadecanoic acid, ester with 2,2'-[oxybis(methylene)]bis[2-(hydroxymethyl)-1,3-propanediol] (CAS 70969-57-2) is considered to be not toxic. The assessment is based on a chronic toxicity study on Daphnia magna according to OECD 211 determining a NOEC (21 d) of ≥ 100 mg/L. Furthermore the substance is not classified for specific target organ toxicity, carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals (See Section 5.9). The criteria for “T” based on mammalian effects are therefore not met.

Conclusion

In conclusion, the substance is not PBT/vPvB.