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PBT assessment

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PBT assessment: overall result

Reference
Name:
293-615-0
Type of composition:
legal entity composition of the substance
State / form:
other: waxy solid
Reference substance:
293-615-0
Reference substance:
293-615-0
Reference substance:
293-615-0
Reference substance:
293-615-0
Reference substance:
293-615-0
Reference substance:
293-615-0
Reference substance:
293-615-0
Reference substance:
293-615-0
Reference substance:
293-615-0
Reference substance:
293-615-0
PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

The substance has been determined to be readily biodegradable and will not persist in the environment.

Bioaccumulation

Log Kow was determined using the HPLC method (OECD 117 and EU Method A.8) and found to be in the range 5.86 to > 10.0. The substance is not expected to bioaccumulate because, in accordance with ECHA Guidance on information requirements and chemical safety assessment Chapter R11: PBT/vPvB assessment (Version 3.0; June 2017), a decreasing relationship between BCF and Log Kow is observed at high Log Kow (> 6) and the aquatic BCF of a substance is likely to be < 2000 if the Log10 Kow value is higher than 10. Further evidence of limited uptake stems from the acute ecotoxicity studies involving three trophic levels (fish, Daphnia and algae) where NOEC values based on loading rates were higher than the limit of water solubility and classification of the substance was not required.

Toxicity

Based on available evidence, and in accordance with Regulation (EC) No. 1272/2008, the substance does not meet the criteria for classification as a carcinogen (category 1A or 1B), germ cell mutagen (category 1A or 1B) or reproductive toxin (category 1A, 1B or 2). Furthermore, there is no evidence of chronic toxicity and the substance does not meet the criteria for classification for specific target organ toxicity (STOT RE 1 or STOT RE 2). With respect to the environment, no toxic effects were reported at saturation in three trophic levels (fish, Daphnia and algae), the substance is not classified as environmentally hazardous when compared to criteria for readily biodegradable substances given in Regulation(EC) No. 1272/2008, and the chemical safety assessment currently raises no concerns. However, present regulatory obligations do not require investigation of long-term exposure to the substance in fish and it is not possible to definitively conclude not T (see ECHA guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 3.0; June 2017).

Likely routes of exposure:

Human exposure via the dermal route plus release to the environment via waste water.