Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Environmental fate & pathways

Biodegradation in water and sediment: simulation tests

Currently viewing:

Administrative data

Link to relevant study record(s)

Description of key information

Standard biodegradation studies are not applicable to petroleum UVCB substances, therefore in accordance with Annex XI Section 1.3 testing is not scientifically necessary and the endpoint has been fulfilled using QSAR calculations for relevant constituents. Full justifications for this QSAR are presented in 'Attached justification', but in brief these are justified because:

- the results are obtained from a QSAR model whose scientific validity has been established

- petroleum substances fall within the applicability domain of the QSAR model

- results are adequate for the purposes of risk assessment

- adequate and reliable documentation is provided

Key value for chemical safety assessment

Additional information

The substance is a hydrocarbon UVCB. Standard tests for this endpoint are intended for single substances and are not appropriate for this complex substance. However, this endpoint is characterised using quantitative structure property relationships for representative hydrocarbon structures that comprise the hydrocarbon blocks used to assess the environmental risk of this substance with the PETRORISK model (see Product Library in PETRORISK report attached in IUCLID section 13).  

The compositions of both registrants were available, and both were run. For the composition 1, the model predicted a surface water half life of between 1.02 and 865 days, whereas for the composition 2, a surface water half life of between 1.18 and 28,755 days.  For the composition 1, the model predicted a sediment half life of between 4.07 and 3,459 days, whereas for the composition 2, a sediment half life of between 4.72 and 115,022 days. It should be borne in mind that this is the full range of predicted values, and that this may be misleading or unrepresentative of the properties of the UVCB substance as a whole. The range should therefore be treated with caution and not taken out of context.  

For purposes of PBT assessment, the substance has been assessed using a combination of QSAR predictions and confirmatory experimental testing for representative constituents using a hydrocarbon block approach. For details see report titled 'Evaluation of PBT for Petroleum Substances' in IUCLID section 13.

The half-lives of representative constituents of registration substance have also been estimated using the EPISUITE v4.11 BioHCwin model (2017), which uses methodology described by Howard et al. (2005). For the composition 1, thee estimated BioHCwin half-lives range from 1.02 to 865 days, whereas for the composition 2 - 1.18 to 28,800 days.