A mixture of: 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C16)alkylacetamide; 2,2',2'',2'''-(ethylenedinitrilotetrakis-N,N-di(C18)alkylacetamide

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

"P/vP"

It cannot be ruled out that the substance may be a potential P or a vP.

This is based upon the available data (OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test and EU Method C.4-D (Determination of the "Ready" Biodegradability - Manometric Respirometry Test, see section 5.2.1) it is to be concluded that no biodegradation was observed in either study.

Furthermore, Biowin 2 (Non-Linear Biodeg Probability) predicts a probability of 0.0004 which indicates that the substance does not biodegrade fast although Biowin 3 is equivocal owing to the different chemical entities anticipated to be present within the UVCB substance. Biowin 6 (MITI Non-Linear Biodeg Probability) with a predicted probability of 0.2315 indicates the substance to be NOT Readily Biodegradable.

However, there are no inherent biodegradation studies available nor simulation of biodegradation studies available. In addition, the water solubility is negligible (< 0.05 mg/l), see section 4.8.

Therefore, to be conclusive on persistence simulation studies should be considered based upon Figure R. 11-3 in the ECHA "Guidance on Information Requirements and Chemical Safety Assessment; Chapter R. 11: PBT/vPvB assessment; Version 2.0: November 2014.

"B/vB"

The substance is NOT a B/vB.

For several analytical and physical reasons a valid bioaccumulation study cannot be performed. An analytical detection method is not available, neither for the substance itself nor the radio labelled substance. Moreover, due to the low water solubility and the high molecular weight range, a homogeneous distribution of the substance in the test medium cannot be guaranteed.   Furthermore, due to the physico-chemical properties of the substance, bioaccumulation testing is not reasonable. As the substance is neither soluble in water nor in octanol, the analytically determination of the log Pow is technically not feasible. Therefore the log Pow was calculated according to Rekker, in the range from 41 to 67 [BASF AG, 1994]. The substance with a very high calculated log Pow > 10, reduced bioaccumulation is expected.  Additionally a high molecular weight between 1630 and 2310 g/mol and the medial molecular length above 1.7 nm, indicates a low bioavailability. As described in the “Guidance on information requirements and chemical safety assessment (Chapter R.11: PBT Assessment) a low bioaccumulation potential can be assumed.

In addition, BCFBAF predicts the BCF to be 3.16 L/Kg indicated very low potential for bioaccumulation.

"T"

The substance is NOT a T.

The NOEC (fish) is > 10 mg/l (nominal) - see section 6.1.2; the NOEC for aquatic invertebrates is > 10 mg/l - see section 6.1.4 and the EC50 for aquatic algae and cyanobacteria is > 80 mg/l - see section 6.1.5.

Furthermore, the substance does NOT meet the criteria for classification as carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) according to the CLP Regulation.

In addition, there is other evidence of chronic toxicity, as identified by the substance meeting the criteria for classification: STOT RE 1, or STOT RE 2 according to the CLP Regulation.