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EC number: 228-532-0
CAS number: 6290-03-5
The ready biodegradability of the source substance
(R/S)-1,3-butanediol was studied in a Modified Sturm Test following OECD
301B. The test substance was degraded to 81% (CO2/ThCO2) after 29 days.
The 10-days window was met. The source substance 1,3-butanediol is
readily biodegradable according to OECD criteria.
It is considered appropriate and scientifically justifiable to use
the available ready biodegradability data for the source substance to
address the ready biodegradability endpoint for the target substance. In
this regard, based on the results of a key GLP-compliant study that was
conducted according to OECD guideline 301 B / EU Method C.4-C, the
target substance can be concluded to be readily biodegradable.
HYPOTHESIS FOR THE ANALOGUE APPROACH
Data for butane-1,3-diol (CAS No. 107-88-0) is used to address the ready
biodegradability data requirement for (R)-(-)-butane-1,3-diol (CAS No.
6290-03-5) in an analogue read-across approach. The basis for this
read-across approach is the extreme structural similarity of the source
and target substances, in that the source substance is a racemic mixture
of a pair of enantiomers, whereas the target substance is solely the
R-enantiomer of that source pair. Two compounds that are enantiomers of
each other have the same physical properties, except for the direction
in which they rotate polarized light and how they interact with
different optical isomers of other compounds (ECHA, 2008). Passive
absorption of a substance into a test species and distribution through
its tissues are governed by the physical-chemical properties of the
substance, particularly its molecular size, log P, and water solubility
(ECHA, 2014), and are therefore expected to be exactly the same for both
enantiomers. The R-enantiomer half of the source substance and all of
the target substance have been shown to metabolise in a mammalian system
to a physiological ketone body, whereas the S-enantiomer of that ketone
body derived from the other half of the source substance has been shown
to metabolise into a compound that is not naturally present, but which
can still be utilized by a less direct pathway (Desrochers et al.,
1992). On the premise that the mixed microbial inoculum used in
biodegradation studies will possess a considerably broader range of
enzymes than a mammalian system, the minor difference in the rates of
metabolism of the two enantiomers observed by Desrochers et al. (1992)
is not expected to exist in their biodegradation rates, and the
experimentally determined “readily biodegradable” result for the source
substance is therefore directly applicable to the target substance.
The biodegradation in water - simulation testing on ultimate
degradation in surface water and sediment simulation testing studies do
not need to be conducted because the substance is readily biodegradable
(study scientifically not necessary). Identification of degradation
products does not need to be conducted because the substance is readily
biodegradable - [study scientifically not necessary]
The biodegradation in soil: simulation testing study does not need
to be conducted because the substance is readily biodegradable (study
scientifically not necessary). Identification of degradation products
does not need to be conducted because the substance is readily
biodegradable - [study scientifically not necessary].
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.
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