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EC number: 695-097-5
CAS number: 15789-90-9
Based on the key study the registered substance is considered to be
readily biodegradable for the chemical safety assessment.
commercial qualities of the registration substance have been tested in
the OECD 301F Manometric Respiratory Test: Isoraldeine
Cetone Alpha (Key Study, Kreutzer 2012) and Isoraldeine 95 (Supporting
Study, Rudio 1997). The level of biodegradation achieved after 28 days
was 71% and 77% respectively. The 10-day window was fulfilled in the key
study (34% on day 7; 66% on day 17) and only 1% below the pass limit in
the supporting study (5% on day 5, 59% on day 15). The
test concentrations employed in the two studies were 30 mg/L and 100
mg/L respectively. The latter is significantly higher than the water
solubility of Isoraldeine 95, which has been determined to be 23.1 mg/L.
This means that the biodegradation rate will be controlled by the
dissolution rate and likely explains why the 10-day window in the study
performed at 100mg/L was not quite met. For this reason the
biodegradation study on Isoraldeine 95 (Rudio 1997) was considered
reliability with restrictions and used only as a supporting study. Based
on the key study and given that environmentally relevant concentrations
will be significantly lower than even the 30mg/L test concentration used
in this study, the registration substance is considered to be readily
the purposes of the PBT assessment, the impurities present in the
registered substance have also been considered. These are isomers of the
main constituent having the same molecular formulae (C14H12O), same
chemical functionality (ketone) and identical/similar arrangement of
atoms (i.e. carbon skeleton). For two impurities (CAS 51703-99-2 and CAS
138506-81-7), the only structural difference compared to the main
constituent is the position
of the double bond associated with the cyclohexyl ring, which is not
expected to significantly affect biodegradation properties. For the
third impurity (CAS 93303-56-8), the C5 alkyl side chain is linear (“pent-1-en-3-one”)
as opposed to branched (“3-methyl-but-3-en-2-one") which is expected to
improve the biodegradability profile of this impurity. Therefore,
given that the registered substance has passed the stringent criteria of
a ready biodegradability screening test and that any impurities present
are isomers of the main constituent with expected similar or more easily
biodegradable profiles, it
can be concluded that the all underlying components of the registered
substance are readily biodegradable and not persistent.
inhibition control was included in the supporting study (Rudio, 1997).
At the concentration used in the test (100 mg/l), Isoraldeine 95 was not
inhibitory to the micro-organisms. This concentration can be considered
as a NOEC for the toxicity to STP microorganisms.
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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