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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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Name:
Fatty acids, C16-18 (even numbered), stearyl esters
Type of composition:
boundary composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Fatty acids, C16-18 (even numbered), stearyl esters
Reference substance:
Fatty acids, C16-18 (even numbered), stearyl esters
Reference substance:
Fatty acids, C16-18 (even numbered), stearyl esters
Name:
Fatty acids, C16-18 (even numbered), stearyl esters
Type of composition:
legal entity composition of the substance
State / form:
solid: particulate/powder
Reference substance:
Fatty acids, C16-18 (even numbered), stearyl esters
Reference substance:
Fatty acids, C16-18 (even numbered), stearyl esters
Reference substance:
Fatty acids, C16-18 (even numbered), stearyl esters
Reference substance:
Fatty acids, C16-18 (even numbered), stearyl esters
Reference substance:
Fatty acids, C16-18 (even numbered), stearyl esters
Reference substance:
Fatty acids, C16-18 (even numbered), stearyl esters
Reference substance:
Fatty acids, C16-18 (even numbered), stearyl esters
Reference substance:
Fatty acids, C16-18 (even numbered), stearyl esters
Reference substance:
Fatty acids, C16-18 (even numbered), stearyl esters
PBT status:
the substance is not PBT / vPvB
Justification:

The PBT assessment ofFatty acids, C16-18, stearyl esters (CAS 85536-04-5)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

Fatty acids, C16-18, stearyl esters (CAS 85536-04-5)is readily biodegradable according to the OECD guideline criteria. Thus, the test substance does not meet the screening criterion for persistency and it is not considered to be P or vP.

 

Bioaccumulation

The potential for bioaccumulation was not assessed because bioaccumulation is not a required endpoint according to Regulation (EC) No 1907/2006, Annex VIII. Moreover, based on the ECHA Guidance R.11, chapter R.11.4.1 (ECHA, 2017), it is considered justified to only further assess the bioaccumulation potential of a substance if the substance also meets the P/vP criteria.

  

Toxicity

Available studies for short-term and long-term aquatic toxicity indicate no aquatic hazard up to the limit of water solubility (<< 0.507 mg/L, 20 °C, OECD 105). Furthermore, the substance is not classified according to the consolidated version of Regulation (EC) No 1272/2008 and further amendments (ATPs). Therefore, the criteria set out in Annex XIII of Regulation (EC) No. 1907/2006 are not met and it is concluded thatFatty acids, C16-18, stearyl esters (CAS 85536-04-5) is not T.

In conclusion, the substance is not PBT/vPvB.