Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

Administrative data

PBT assessment: overall result

PBT status:
the substance is not PBT / vPvB
Justification:

Persistence

 

Not p or vP

 

The test item attained only 17 % biodegradation after 28 days (OECD 301B and EU Method C.4-C) and is a complex mixture for which investigation of hydrolysis via OECD test guidelines is not recommended due to non-pseudo first order hydrolysis plots and hydrolysis products that can be analytically indistinguishable from the starting components. However, the main functional groups within the components of the test item are esters (which usually hydrolyse at environmentally relevant pH and temperature) plus carboxylic acids (which will be hydrolytically stable at environmentally relevant pH and temperature). It is therefore expected that the test item will hydrolyse at environmentally relevant pH and temperature.

 

Bioaccumulation

 

Not B or vB

 

Since the test item is a complex UVCB, Log Kow was determined using the HPLC method (OECD 117 and EU Method A.8) and the weighted value was reported as 4.65. However, the mean Log Kow for two out of three samples was less than 4.5 indicating that uptake of the organic components of the test item is unlikely and that the aquatic BCF will be below the 2000 L/kg threshold where bioaccumulation becomes a concern (see ECHA Guidance on Information requirements and chemical safety assessment Chapter R11: PBT assessment (Version 2.0; November 2014). Further evidence for low bioaccumulation potential is provided by the most abundant UVCB component (25 %) where EPISuite BCFBAF v3.01predicts BCF as 3.16 L/kg wet weight based on SMILES for the component even though Log Kow for the same component is estimated as 4.85. As a result, bioaccumulation of the UVCB test item is not expected to occur as the result of exposure to substance or its constituents.

 

Toxicity

 

Potentially T

 

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) or germ cell mutagen (category 1A, 1B or 2).Effects on the liver observed during investigation of repeated dose toxicity via the oral route cannot be completely explained by direct irritancy of the test item but the toxicological significance of these findings were considered to be equivocal.Hence 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, short-term results required by present regulatory obligations provide no evidence of environmental toxicity and the chemical safety assessment gives no cause for concern. However, these data are considered screening information and cannot be used to definitively conclude not T (see ECHA guidance on Information Requirements and Chemical Safety Assessment Chapter R.11: PBT/vPvB assessment (Version 2.0; November 2014)).

Likely routes of exposure:

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