Reaction products of methyloxirane with formaldehyde, oligomeric reaction products with aniline and reaction products of methyloxirane with 2,2'-oxydiethanol

PBT assessment

PBT assessment: overall result

PBT status:

the substance is not PBT / vPvB

Justification:

An evaluation of the inherent properties of the test substance is performed against the ANNEX XIII criteria. If insufficient data were available, the screening criteria as laid down in ECHA Guidance on information requirements and chemical safety assessment Chapter R.11: PBT Assessment (2008) were applied.

Based on the results of the available biodegradation screening tests in water, the substance DADPM/DEG/PO is concluded not to be readily biodegradable however it exhibits inherent (primary) biodegradability, and therefore is not expected to persist indefinitely in the environment. The substance is identified as not P according to the PBT screening criteria.  

Based on the average log Pow of 3.48, not fulfilling the screening criterium, the substance DADPM/DEG/PO can be concluded to have a low potential for bioaccumulation (not B/vB). 

 

Finally, because the substance does not fulfill the screening criterium based on acute toxicity for being considered as T, and does not fulfill two of the three Annex XIII criteria (classification for hazardous properties for human health), enough evidence is available for concluding that the substance is not T.

In addition, the EAWAG-BBD PPS tool was used to predict biotransformation products likely or very likely to be formed through aerobic microbial degradation. A total of 546 possible transformation products that were identified, were assessed for potential PBT/vPvB properties using appropriate QSAR models. The biodegradability, log Kow and BCF of the modelled (end) products were predicted using the relevant models available in the EPI Suite software. The vast majority of the degradation (end) products were predicted not to be readily biodegradable and are therefore considered to be potentially P/vP. The log Kow values for all the predicted metabolites were estimated to be less than 4.5 (a maximum Log Kow of 3.34 was predicted) and therefore none of those metabolites is expected to have a high potential for bioaccumulation. This was confirmed by their predicted BCF values, which ranged from 0.9 to 233. In addition, their aquatic toxicity was also very low (not B/vB). Further supporting QSAR calculations were made to estimate the aquatic toxicity of the predicted biotransformation products. This assessment pointed out that the aquatic toxicity was of the biotransformation products was overall low. The lowest EC50 predicted was 0.997 mg/L, which is almost an order of magnitude above the screening cutoff value to consider a chemical as potentially T. As such, based on their predicted aquatic toxicity, none of the biotransformation products should be considered to meet the T criterion.

Based on the available data it can be concluded that neither of the potential degradation (end) products are likely to be PBT/vPvB. As none of the metabolites is a potential PBT/vPvB substance, this further supports the conclusion that the substance should not be considered as a PBT/vPvB substance.