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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,N-bis[3-(dimethylamino)propyl]-N',N'-dimethylpropan-1,3-diamine) is not readily biodegradable; a mean degradation rate of 2.4% was observed after 28 days in a ready biodegradability assay. In the absence of additional information to make a definitive determination, it may be presumed that the substance is “persistent” (presumably “P”) and potentially very persistent (potentially “vP”). 

 

Screening-level and definitive data indicate that the substance is “not bioaccumulative” (“not B”) and “not very bioaccumulative” (“not vB”). The screening-level determinations are based on an experimentally-determined log Kowof 0.05, which is substantially below the screening criterion (log Kow4.5) for both “not B” and “not vB”. A definitive determination that the substance is “not B” and “not vB” is based upon the bioaccumulation study in carp, which indicated that bioconcentration is not of concern; the BCF value2 from the low concentration test and BCF≤ 0.7 from the high concentration testare each substantially below the definitive criteria for both “B” (> 2,000 L/kg) and “vB” (>5,000 L/kg). 

 

Screening-level and definitive data indicate that the substance is “not toxic” (“not T”). The determinations that the substance is “not CMR” and “not T, R48” or “Xn, R48” under the DSD/DPD classification, and are not carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), toxic for reproduction (category 1A, 1B or 2) or exhibit chronic toxicity (STOT-RE category 1 or 2) under the CLP Regulation, 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) = 48 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. 

 

Therefore, although a complete definitive determination cannot be made with respect to three endpoints (P, vP, and T), screening level criteria indicate that the substance is potentially “P”, potentially “vP”, “not B”, “not vB”, and “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, ECHA, May 2008, Section R.11.1.2.2, p. 13.

 

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