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Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

Reference
Name:
N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine
Type of composition:
boundary composition of the substance
State / form:
liquid
Reference substance:
N-[3-(dimethylamino)propyl]-N,N',N'-trimethylpropane-1,3-diamine
PBT status:
the substance is not PBT / vPvB
Justification:

Screening-level data indicate that the substance (N-[3-(dimethylamino)propyl]-N,N’,N’-trimethylpropane-1,3-diamine) is not readily biodegradable. In the absence of additional information to make a definitive determination, it may be presumed that the substance is potentially “persistent” (potentially “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, 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” 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 long-term screening-level data for aquatic toxicity (i.e., EC50(daphnids) = 2.2 mg/L > 0.1 mg/L) indicate that the substance is “not T” with respect to aquatic toxicity.

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”).