Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 945-893-6 | CAS number: -
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
Standard bioaccumulation 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). 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.
The compositions of both registrants were available, and both were run in PETRORISK (v7.04) . For the composition 1, the model predicted a BCF of between 0 and 75, whereas for the composition 2, a BCF of between 0 and 29.
The bioconcentration factor (BCF) values of representative constituents of registration substance has also been estimated using the EPISUITE v4.11 BCFBAF (2017) model. For the composition 1, the estimated BCF values of representative constituents of range from 13.5 to 70,794 L/kg ww and 0.43 to 2,627 L/kg ww Regression based estimation and Arno-Gobas method (upper trophic) (5% lipid normalisation), respectively, whereas for the composion 2, the estimated BCF values of representative constituents of range from 12.9 to 19,055 L/kg ww and 0.43 to 6,304 L/kg ww Regression based estimation and Arno-Gobas method (upper trophic) (5% lipid normalisation), respectively.
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.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
