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PBT assessment

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PBT assessment: overall result

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

1,1'-[iminobis(ethyleneiminoethylene)]bis[3-(octadecenyl)pyrrolidine-2,5-dione] is considered to be potentially persistent (P) or very persistent (vP), not bioaccumulative (B) or very bioaccumulative (vB) and not toxic (T). Based on this, the substance is not a PBT/vPvB.

Persistence Assessment

The OECD 301 B test conducted determined that the substance is not readily biodegradable. Therefore the substance is regarded as being potentially persistent (P) or very persistent (vP).

Bioaccumulation Assessment

The substance has a Log Kow of 13.9396 which is sufficiently high so as to be regarded as a physicochemical indicator for hindered uptake and distribution in general (Figure R.11-4 of Chapter R11: PBT/vPvB assessment; version 3.0, 2017).Based on this, the substance was initially considered to be potentially bioaccumulative (B) or very bioaccumulative (vB). No bioaccumulation experimental studies are known to have been undertaken. Therefore the following Bioconcentration Factors (BCF) have been estimated using EPI Suite, based on a log Kow of 13.9396, and using the regression-based and Arnot-Gobas methods:

Regression-based method:

o       Log BCF:  0.72  (BCF = 5.29 L/kg wet-wt)

Arnot-Gobas BCF & BAF Methods (including biotransformation rate estimates):

o       Log BCF (upper trophic) =  -0.045  (BCF = 0.9017 L/kg wet-wt)

o       Log BAF (upper trophic) =  1.645  (BAF = 44.2 L/kg wet-wt)

o       Log BCF (mid trophic)   =  -0.025  (BCF = 0.9447 L/kg wet-wt)

o       Log BAF (mid trophic)   =  1.293  (BAF = 19.64 L/kg wet-wt)

o       Log BCF (lower trophic) =  -0.020  (BCF = 0.9552 L/kg wet-wt)

o       Log BAF (lower trophic) =  1.029  (BAF = 10.7 L/kg wet-wt)

Arnot-Gobas BCF & BAF Methods (assuming a biotransformation rate of zero):

o       Log BCF (upper trophic) =  -0.044  (BCF = 0.9028 L/kg wet-wt)

o       Log BAF (upper trophic) =  1.704  (BAF = 50.61 L/kg wet-wt)

The regression-based and Arnot-Gobas methods, indicated that the substance has BCF << 2000 L/kg; therefore it can be concluded that the substance does not meets the B or vB criteria.

Toxicity Assessment

The substance does not demonstrate signs of acute aquatic toxicity in either the studies required as a part of the standard Annex VII and VIII information requirements or any other available information. There are no long term NOEC or EC10 values for marine or freshwater organisms less than 0.01 mg/L, and the substance does not meet the criteria for classification as carcinogenic, mutagenic or toxic for reproduction and there is no evidence of chronic toxicity meeting the criteria for classification in appropriate repeated exposure studies.

Comparison of the available data on the substance against the both the screening criteria and assessment criteria set out respectively in Sections 3.1.3 and 1.1.3 of Annex XIII to the REACH Regulation indicates that the existing data demonstrate a lack of applicable hazard classification and thus (1,1'-[iminobis(ethyleneiminoethylene)]bis[3-(octadecenyl)pyrrolidine-2,5-dione] does not meet the Toxicity (T) criterion.