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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 is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2014).

Persistence (P) Assessment:

The substance Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol is expected to be readily biodegradable. Therefore, the substance is not expected to be persistent in the environment and it does not meet the Persistent (P) or very Persistent (vP) criteria.

Bioaccumulation (B) Assessment:

Due to the low water solubility, rapid environmental biodegradation a relevant uptake and bioaccumulation in aquatic organisms is not expected. This is supported by low BCF values <2000 L/kg (BCFBAF v3.01, Arnot-Gobas, including biotransformation, upper trophic). Even though Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol is outside the applicability domain of the model, the estimation can be used as supporting indication of low bioaccumulation potential. The model training set is only consisting of substances with log Kow values of 0.31 - 8.70. But it supports the tendency that substances with high log Kow values (> 10) have a lower potential for bioconcentration as summarized in the ECHA Guidance R.11 and they are not expected to meet the B/vB criterion (ECHA, 2014).

Toxicity (T) Assessment:

Fatty acids, C18-unsatd., dimers, reaction products with fatty acids, C14-18 and C16-18-unsatd. and propylidynemethanol is considered not toxic. Long-term toxicity testing with Daphnia magna resulted in a NOELR (21 d) ≥ 0.11 g/L (read across). The substance is furthermore not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity according to the 6th ATP of Regulation (EC) No. 1272/2008 (CLP). The criteria for “T” are therefore not met.

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