Registration Dossier

Environmental fate & pathways

Endpoint summary

Administrative data

Description of key information

SPE1415 is a complex UVCB substance. As discussed in the ‘Read-Across Justification Document’ section 13, data provided for the analogue substances are representative of SPE1415 and suitable for assessment purposes. Study data for each analogue or minor constituent has been evaluated and considered together.

A reliable OECD 306 guideline study for biodegradation in seawater for SPE1415 is available and is included in the dossier. The test substance showed maximum degradation of 43%, achieved after 14 days, and therefore can be considered to be inherently biodegradable under the conditions of the test. This study is taken as the endpoint for biodegradation and no additional degradation testing is necessary.

In accordance with Column 2 of REACH Annex IX, the simulation test on ultimate degradation in surface water, soil and sediment (sections 9.2.1.2, 9.2.1.3 and 9.2.1.4, respectively) are waived as the use of SPE1415 in offshore drilling operations means the direct or indirect exposure of surface water, soil and sediment compartments are considered unlikely.In addition, these tests require the use of a suitably radiolabelled substance or detailed knowledge of the fate of the substance in water and sediment. As a complex UVCB, conducting such a test would not be technically feasible. 

Two reliable studies for bioaccumulation in fish (Common carp,Cyprinus carpio) of the analogue test substances, ATMP and DTPMP, are available and are included in the dossier. Neither study indicated that SPE1415 is likely to bioaccumulate in fish tissue. After 14 days depuration between 93 and 96% of the analogue read-across substance ATMP was shown to have been eliminated (EG&G, 1976). This study suggested that the majority of ATMP was found to be present in faecal matter and in the gut with 12% of the nominal dose estimated to be in the visceral tissue. 

These findings are supported by a reliable study estimating the octanol-water partition coefficient (KOW) of SPE1415 (Jein, 2015). At the environmentally relevant pH of 5.0 the partition coefficient was experimentally determined to be <0.01 (Log10KOWless than -2.0) confirming the test substance is unlikely to bioaccumulate in tissue and is below the cut-off criteria of Log Kow <3 in Column 2 of Annex IX of the REACH Regulation. Further bioaccumulation studies using SPE1415 are waived based on the low potential for bioaccumulation in the experimental studies for the analogue read-across substances ATMP and DTPMP and the very low Log Kow for SPE1415 of <3.

The adsorption coefficient (Koc) has been determined to be <17.8 and the Log10 Koc <1.25, using the HPLC screening method (Jein, 2015). These values indicate that SPE1415 will have a very high mobility in the environment.

Information regarding photo-transformation in air, water and soil are waived as they are not mandatory in accordance with Annex X of the REACH Regulation (EC) No 1907/2006.The hydrolysis endpoint is waived on the basis that this study is not scientifically justified. The chemical structure(s) of the substance do not contain any hydrolysable functional groups and therefore the substance will not hydrolyse under normal environmental conditions.

Additional information