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PBT assessment

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PBT assessment: overall result

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

Persistence Assessment

Amides, C16-C18 (even) , N,N'-ethylenebisis not readily biodegradable according to OECD criteria ( ca 15 % degradation in 28d) but the substance is hardly soluble in water and the very low solubility of the test substance may reduce the availability of the substance in the test medium.

Therefore, an additional calculation was used to investigate the biodegradation of Amides, C16-C18 (even) , N,N'-ethylenebis. A QSAR prediction using the following models shows that the substance is not persistent in the environment.

 

BIOWIN v4.10 Results:

Biowin1 (Linear ModelPrediction)   : Biodegrades Fast

Biowin2 (Non-Linear Model Prediction): Biodegrades Fast

Biowin3 (Ultimate Biodegradation Timeframe): Weeks-Months

Biowin4 (Primary Biodegradation Timeframe): Days

Biowin5 (MITI Linear Model Prediction)   : Biodegrades Fast

Biowin6 (MITI Non-Linear Model Prediction): Biodegrades Fast

Biowin7 (Anaerobic Model Prediction): Does Not Biodegrade Fast

Ready Biodegradability Prediction: NO

The calculation is scientifically accepted and reliable and the estimation results clearly indicate that the substance is not persistent and the biodegradation takes place in a time frame of weeks, further information will not be required for the assessment. The substance is not fulfilling the B and T criteria and it may be considered as not fulfilling the criteria for P.

Amides, C16-C18 (even) , N,N'-ethylenebis is expected to be stable in water and hydrolysis is not expected. If the substance is released to air, the phototransformation is fast and the calculated half life is only 0.2 days.Based on the estimated atmospheric half-life, the substance has a no potential for long-range atmospheric transport, if emitted to air.

 

Bioaccumulation Assessment

A bioaccumulation study is available forAmides, C16-C18 (even) , N,N'-ethylenebis and revealed a BCF of < 6.2. Therefore, the test substance did not exhibit potential for bioconcentration in fish species. Additional information about this endpoint could be gathered through BCF calculation using BCFBAF (v3.00), a subroutine of the EPI Suite™ computer program. The BCF estimated value, based on whole body wet weight, was 5.048, and thus it supports the experimental result.

In conclusion,Amides, C16-C18 (even), N,N'-ethylenebis does not meet the B criterion.

Toxicity Assessment

Amides, C16-C18 (even), N,N'-ethylenebis shows no toxicity in the range of water solubility.

All data give comparable results for fish, invertebrates and aquatic plants.

The substance is not classified as carcinogenic, mutagenic or toxic for reproduction nor is there any evidence of chronic toxicity, as identified by the classifications: T, R48, or Xn, R48 according to Directive 67/548/EEC.

Therefore, Amides, C16-C18 (even), N,N'-ethylenebis does not meet the T criterion.