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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Classification & Labelling & PBT assessment

PBT assessment

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Administrative data

PBT assessment: overall result

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

Summary and conclusions on persistence

The registered substance is a borated ester alkyl amide that hydrolyzes in water to the original starting materials: boric acid, glycerol and coconut fatty acid diethanolamide.Therefore, evaluating the biodegradation in water of the hydrolysis products is an appropriate approach to assessing biodegradation for the registered substance (CAS 1428353-74-5). Proprietary data for a borated alkyl ester (CAS 63310-16-7) supports that the boric acid and glycerol functionality from a borated ester is readily biodegradable but failing the 10 day window.

The remaining hydrolysis product, CAS 68603-42-9, is a fatty nitrogen derived (FND) amide. This category of chemicals was evaluated in an EPA Screening Level Hazard Characterization (Sept., 2010). There is sufficient data available to assess the biodegradation of this material in water. CAS 68603-42-9 is in subcategory 2, group B, of the FND amide category. In a closed bottle test, 51.8% of its theoretical BOD was achieved and was not considered readily biodegradable. However, in a separate test using two different initial concentrations, it achieved 71 and 84% of its theoretical BOD in 28 days and was classified as readily biodegradable. Additionally, 3 other subcategory members (CAS 142-78-9, 120-40-1 and 68140-00-1) were either inherently or readily biodegradable.

 

Biodegradation test data for CAS 63310 -16 -7, was carried forward in the chemical safety assessment. This substance is expected to be readily biodegradable because, while it did not meet the 10 day window validation, it is a UVCB and did exhibit potential for rapid degradation as evidence of >70% degradation was demonstrated over a 28 day period. Based on the weight of evidence from each of the hydrolysis product functionalities, the registered substance is expected to readily biodegrade and therefore does not meet the criteria for persistence.

 

Summary and conclusions on bioaccumulation

 

The log Kow was determined to be 3.57 (OECD 117, weighted average), which is below the screening criteria indicated in Annex XIII (B fulfilled with log Kow of ≥ 4.5). Therefore, the registered UVCB substance is not considered bioaccumulative.

Summary and conclusions on toxicity

Based on the available acute and chronic toxicity data in algae, daphnids, and fish, this substance is expected to cause harmful effects to aquatic organisms in short and long term scenarios. However, experimental results have NOECs greater than 0.01 mg/L and the substance is not expected to be C, M, or R. Therefore, this material does not meet the criterion for toxicity as outlined in ANNEX XIII of Regulation (EC) 1907/2006.