Registration Dossier

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

Screening-level data indicate that the substance N-(2-(dimethylamino)ethoxy)ethyl)-N-methyl-1,3-propanediamine is not readily biodegradable.  Therefore, no conclusions may be drawn with respect to the P/vP properties of the substance.

 

Screening-level data indicate that the substance is “not bioaccumulative” (“not B”) and “not very bioaccumulative” (“not vB”). The screening-level determinations are based on the determined logKow < -3.0 which is substantially below the screening criterion (log Kow4.5) for both “not B” and “not vB”. 

 

Screening-level and definitive data indicate that the substance is “not toxic” (“not T”). The determinations that the substance is “not CMR” (carcinogenic, germ cell mutagenic or toxic for reproduction) and is “not STOT RE” (specific target organ toxicity after repeated exposure“) are definitive determinations of “not T” with respect to human health endpoints. The short-term screening-level data for aquatic toxicity (i.e., EC50(daphnids) = 100 mg/L > 0.1 mg/L) indicate that the substance is “presumably not T” with respect to aquatic toxicity; however, this is not a definitive determination as long-term aquatic toxicity testing data are not available. 

 

Screening level criteria indicate that the substance is “P”, “not vP”, “not B” and “not vB”. The classifications of the substance are definitive determinations that the substance is “not T” with respect to human health endpoints. Although there is not sufficient information to make a determination regarding environmental toxicity, the short-term toxicity data available are not indicative that the substance is “T” and are presumably “not T”.  It is not necessary to have definitive criteria for all five endpoints to make the determinations as to whether the substance is “not PBT” and “not vPvB”. The determination based on screening criteria only requires that “each of the three properties persistency, bioaccumulation and toxicity need to be considered in conjunction” (Chapter R.11, “PBT Assessment”,Guidance on information requirements and chemical safety assessment, version 1.1, ECHA, November 2012, Section R.11.1.2.2, p. 15).

 

In summary, the substance is “not PBT” (“not P”, “not B”, “not T”) and is “not vPvB” (“not vP”, “not vB”).