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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 267-041-6 | CAS number: 67763-18-2
Bioaccumulation: aquatic / sediment
Administrative data
Link to relevant study record(s)
Description of key information
The bioaccumulation potential of Diisooctadecyl malate (CAS 67763-18-2) is expected to be very low.
Key value for chemical safety assessment
Additional information
Experimental data investigating the bioaccumulation potential of
Diisooctadecyl malate (CAS 67763-18-2) are not available. The substance
has a log Pow > 10 indicating a potential to bioaccumulate in biota.
However, the information gathered on environmental behaviour and
metabolism in combination with the QSAR-estimated BCF values provide
enough evidence (in accordance with REACh Regulation (EC) No. 1907/2006,
Annex XI General rules for adaptation of the standard testing regime set
out in Annexes VII to X, 1.2, to cover the data requirements of
Regulation (EC) No. 1907/2006, Annex IX) to state that the substance is
not likely to bioaccumulate. The substance is considered to be readily
biodegradable and is insoluble in water (WS: 6.5-13.5 µg/L at 20 °C).
According to the Guidance on information requirements and chemical
safety assessment, Chapter R.7b, readily biodegradable substances can be
expected to undergo rapid and ultimate degradation in most environments,
including biological Sewage Treatment Plants (STPs). The guidance
document states furthermore that once insoluble chemicals enter a
standard STP, they will be extensively removed in the primary settling
tank and fat trap and thus, only limited amounts will get in contact
with activated sludge organisms (ECHA, 2016). Therefore, after passing
through conventional STPs, only low concentrations of these substances
are likely to be (if at all) released into the environment.
According to the Guidance on information requirements and chemical
safety assessment, Chapter R.7c (ECHA, 2014), even though ready
biodegradability does not per se preclude bioaccumulation potential,
generally (depending on exposure and uptake rates) ready biodegradable
substances are likely to be rapidly metabolised, and therefore,
concentrations stored in aquatic organisms will tend to be low.
A relevant uptake and bioaccumulation in aquatic organisms is not
expected, due to the rapid environmental biodegradation and
metabolization of the substance via enzymatic hydrolysis. Enzymatic
breakdown will initially lead to the free malic acid and isostearyl
alcohol. These hydrolysis products will be metabolised and excreted in
fish effectively (Tocher, 2003).
Estimated bioconcentration (BCF) and bioaccumulation (BAF) values were
calculated for the substance using the BCFBAF v3.01 program (Estimation
Programs Interface Suite™ for Microsoft® Windows v 4.10., US EPA),
assuming biotransformation (Arnot-Gobas method). The estimated BCF
values for the main substance components were 0.89 L/kg.
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.
