Registration Dossier
Registration Dossier
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EC number: 614-590-8 | CAS number: 68552-19-2
PBT assessment
Administrative data
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, 2017).
Persistence (P) Assessment:
The substance Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol (CAS 68552-19-2) 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, polymers with 2-ethylhexanol and neopentyl glycol 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, 2017).
Toxicity (T) Assessment:
Fatty acids, C18-unsatd., dimers, polymers with 2-ethylhexanol and neopentyl glycol is considered not toxic. Acute toxicity tests determined no toxicity of the substance up to the limit of water solubility (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 consolidated version of Regulation (EC) No. 1272/2008 (CLP) considering all further amendments. The criteria for “T” are therefore not met.
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