Formaldehyde, polymer with benzenamine, hydrogenated

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

Screening-level data indicate that the substance is not readily biodegradable. In the absence of additional information to make a definitive determination, it may be presumed that the substance is presumably “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 K_owof 2.68, which is substantially below the screening criterion (log K_ow≤4.5) for both “not B” and “not vB”.  The definitive determinations are based upon an experimentally-determined BCF in the range of 18-219 in carp (i. e., BCF = 18-22 based on the high concentration test; and BCF = 209-219 based on the low concentration test); all values in the BCF range are substantially below the criteria for both B (BCF > 2000 L/kg) and vB (BCF > 5000 L/kg). In addition, the BCFBAF model contained in the EPI Suite model software predicted a BCF value of 27.2 L/kg, an estimated value which falls within the range of experimentally-determined BCF values in carp, and which is substantially below the criteria for both B and vB.

Definitive data indicate that the substance is “toxic” (“T”). The substance has not been determined to be “CMR”, “T, R48” or “Xn, R48” under the DSD/DPD classification. The substance has not been determined to be carcinogenic (category 1A or 1B), germ cell mutagenic (category 1A or 1B), or toxic for reproduction (category 1A, 1B or 2) under the CLP Regulation. However, the substance has been determined to exhibit chronic toxicity (STOT-RE category 2, H373: May cause damage to kidney, through prolonged or repeated oral exposure) under the CLP Regulation, a definitive determination of “T” with respect to human health endpoints. The short-term screening-level data for aquatic toxicity (i. e., EC₅₀(daphnids) = 15.4 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, the substance has been determined to be toxic (“T”) under the definitive criteria.

Therefore, although a complete definitive determination cannot be made with respect to two endpoints (P and vP), the available screening level and definitive data indicate that the substance is presumably “P”, potentially “vP”, “not B”, “not vB”, and “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” (presumably “P”, “not B”, “T”) and is “not vPvB” (potentially “vP”, “not vB”).