Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

Additional information

In a closed bottle test for ready biodegradability following OECD 301D, the test substance degraded up to 21.8% by day 28.  The test material was considered not readily biodegradable under the conditions of the test system. QSAR estimated primary and ultimate biodegradation indices range from days to months. From the EPIWIN model (Meylan and Howard, 1999a) the fate and behavior of the test material in wastewater treatment facilities (WWTF) have been estimated. According to the EPIWIN wastewater estimates, 65.1 and 88.7% of the total mass of the C12 and C14 isomers, respectively, entering a WWTF would ultimately be removed. Biodegradative losses would be low equaling 0.56 and 0.74% of the total with the predominant loss mechanism being adsorption to sludge material accounting for 61.95 and 87.2% of the removed C12 and C14 isomer, respectively.

No further biodegradation testing is regarded to be necessary for the test material, for the following reasons:

1.  All PEC/PNEC ratios are <1.

2.  The PBT assessment indicated that this material is not a PBT and likely not persistent.

3.  Direct and indirect exposure of sediment and soil is unlikely.

1.  All PEC/PNEC ratios are <1

 

For each Emission Scenario (ES), ES1, 2 and 3, formulation into fuel additives, derivative manufacture and formulation into additives for use in lubricants, greases, etc., respectively, PEC/NEC ratios were below 1.0. The PEC/PNEC ratios below 1.0 indicate that for STP, freshwater, freshwater sediment, soil, marine water and marine sediment,the potential for adverse environmental effects as a consequence of the appropriate use of the test material is considered negligible.

2. The test material does not fulfill the PBT criteria

3. Direct and indirect exposure of sediment and soil

 

In the Reach Document “Guidance on information requirements and chemical safety assessment Chapter R.7b: Endpoint specific guidance” (2008) simulation testing on ultimate degradation in soil or sediment need not be completed if direct and indirect exposure of soil or sediment is unlikely. According to the guidance document:

“If there is no exposure of the soil (or sediment), or the exposure is so low that no refinement of the PECregionalis required, then this test may not be necessary. If the substance is considered a PBT/vPvB candidate, then it may be necessary to consider this test if soil is environmental compartment of concern (see Section R.7.9.6).”

 

In addition, according to Table R.16-1of the ECHA Guidance[Direct releases to environmental compartments in different scenarios], direct release to soils in the industrial setting (local scale) is not supported. Therefore, for industrial processes, direct application to soil would not be acceptable.

Primene™ 81R amine is not sold directly to consumers but is formulated industrially into end-use products such as fuel additives, lubricants and greases, etc. Once derivatized and/or formulated into all end-use products such as additive packages, un-reacted Primene™ 81R is present at trace levels(<0.1 wt%).

The CSR states for each ES and with regard to RMMs associated with “Conditions and measures related to external treatment of waste” that “No application of sludge to soil” would be permitted.

Taken in total, during industrial processing direct application to soil would not be anticipated. Application of sludge to soil is addressed for each ES via the RMM prohibiting land application of sludge to soil. Finally, the percentage of Primene™ 81R in end use products (<0.1 wt%) precludes any significant deposition of this materailto soil via disposal of end use products and subsequent land application of STP biosolids.

Hence, the endpoints 'biodegradation in water and sediment' as well as 'biodegradation in soil' are waived.