Registration Dossier
Registration Dossier
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EC number: 275-019-2 | CAS number: 70913-98-3
PBT assessment
Administrative data
PBT assessment: overall result
- PBT status:
- the substance is not PBT / vPvB
- Justification:
The PBT Assessment for Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3) is based on the criteria set out in the “Guidance on information requirements and chemical safety assessment, Chapter R.11: PBT Assessment” (ECHA, 2012).
Persistence
Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3) is not readily biodegradable. A degradation rate of 7.6% (CO2 evolution) was determined in a study conducted with a read-across substance according to OECD 301B. Fatty acids, tall oil, esters with dipentaerythritol is hence considered to be P or vP.
Bioaccumulation
Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3) has a log Kow of > 10 (KOWWIN v1.68) indicating a potential for bioaccumulation. But due to the low water solubility and metabolisation via enzymatic hydrolysis of the substance, a relevant absorption and bioaccumulation in aquatic organisms is not expected. This is confirmed by calculated low BCF/BAF values calculated for the main components of the substance (0.89 L/kg; Arnot-Gobas estimate, upper trophic). Please refer to IUCLID Section 5.3 for a detailed overview on bioaccumulation of the substance. In conclusion, the substance is not considered to be B or vB.
Toxicity
Fatty acids, tall oil, esters with dipentaerythritol (CAS 70913-98-3) 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. In addition, the substance is not classified for specific target organ toxicity, carcinogenicity, mutagenicity or reproductive and developmental toxicity in mammals (See CSR Chapter 5.9). The criteria for “T” based on mammalian effects are hence not met.
Conclusion
In conclusion the substance is not considered to meet the criteria to be classified as PBT or vPvB based on the available data.
References
ECHA, 2012. Guidance on information requirements and chemical safety assessment – Chapter R.11: PBT assessment. European Chemicals Agency, Helsinki
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