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EC number: 239-937-7
CAS number: 15834-04-5
Readily biodegradable: 71.9 - 99.8% (CO2 evolution) after 28 d (OECD 301B)
In accordance to Regulation (EC) No. 1907/2006 Annex XI, 1.5 a read
across to structurally related category members pentaerythritol
tetraesters of n-decanoic, n-heptanoic, n-octanoic and n-valeric acids
(CAS-No. 68424-31-7), reaction mass of Heptanoic acid
3-pentanoyloxy-2,2-bis-pentanoyloxymethyl-propyl ester, Heptanoic acid
and Heptanoic acid
(CAS 68441-94-1), decanoic acid, mixed esters with heptanoic acid,
octanoic acid, pentaerythritol and valeric acid (CAS 71010-76-9) and
fatty acids, C16-18 and C18-unsaturated, tetraesters with
pentaerythritol (CAS 68604-44-4) and pentaerythritol tetraoleate (CAS
19321-40-5) was conducted. The read-across substances are characterized
by the same alcohol component (pentaerythritol) tetra-esterified with
similar fatty acids (C5-C10) or with longer fatty acids (C16 and C18)
and can therefore be used for read-across – in the latter case as worst
case approach since the chain length is the determining factor for
biodegradation. The first step of biodegradation is the enzyme-catalysed
cleavage of the ester bond by lipase or esterase which are synthesized
by a wide range of microorganisms (Boczar et al., 2001). The free fatty
acids (C4 to C24 incl. C18 unsatd.) are known to be degraded rapidly and
utilized as substrates by activated sludge microorganisms (Kangala &
Medrzycka, 2008). In the first study conducted with CAS 68424-31-7 the
biodegradation was tested in a CO2 Evolution Test according to OECD 301B
using domestic activated sludge (non adapted) as inoculum (Häner, 2006).
At test termination after 28 days Häner observed a mean degradation of
96% and the 10-day-window was reached even though this is a UVCB
substance and thus consist of constituents with different chain-lengths,
hence sequential (instead of concurrent) biodegradation can take place.
Thus, the read across-substance is readily biodegradable according to
The second study investigating the ready biodegradability of CAS
68441-94-1 was also conducted according to OECD 301B (CO2 Evolution
Test) using domestic activated sludge (non adapted) as inoculum
(Bouillon and Defleur, 1999). A test concentration of 20 mg/L (TOC) was
applied. A mean biodegradation of 75.7% based on O2 consumption was
observed after 26 d. Within the 10-day time window the 60% level was not
passed, nevertheless according to Annex I to the OECD Guideline for
Testing of Chemicals ‘Revised introduction to the OECD guidelines for
testing of chemicals, section 3’ (OECD, March 2006), the 10-day window
should not be considered for this UVCB substance and due to a
degradation of >60 % within 28 days the substance can be regarded as
The third study was conducted with Decanoic acid, mixed esters with
heptanoic acid, octanoic acid, pentaerythritol and valeric acid (CAS
71010-76-9) (Febbo, 2006). This study was conducted according to OECD
301F under aerobic conditions using fresh activated, non-adapted sludge
from a municipal sewage treatment plant (STP) as inoculum. A test
concentration of 50.2 mg/L (test material) was applied. A mean
biodegradation of 84% based on O2 consumption was observed after 28 d.
Since the substance reached the pass level for OECD 301F (biodegradation
is > 60% after 28 d) the substance is stated to be readily biodegradable
according to the OECD criteria. The fourth study selected for read
across was conducted with fatty acids, C16-18 and C18-unsatd.,
tetraesters with pentaerythritol (CAS 68604-44-4) according to OECD
Guideline 301B under aerobic conditions using non-adapted activated
sludge as inoculum (Häner, 2007). A test concentration of 22.8 mg/L
(TOC) was applied. Based on CO2 evolution a mean biodegradation of 76%
was observed after 28 days. Hence, the substance is determined to be
readily biodegradable according to OECD criteria.
These results are supported by a further GLP-Guideline study according
to OECD 301B with pentaerythritol tetraoleate (CAS-No. 19321-40-5) using
non-adapted activated sludge as inoculum (Desmares-Koopmans, 1997). A
test item concentration of 15.6 mg/L was applied. Based on CO2 evolution
biodegradation was observed to be in the range of 71.9 to 99.8 % after
28 days. Hence, the substance is determined to be readily biodegradable
according to OECD criteria.
Based on the results from structurally related read-across substances
(in accordance to Regulation (EC) No 1907/2006 Annex XI, 1.5) it can be
concluded that 2,2-bis[[(1-oxopentyl)oxy]methyl]propane-1,3-diyl
divalerate (CAS-No. 15834-04-5) is readily biodegradable according to
the OECD criteria.
A detailed reference list is provided in the technical dossier (see
IUCLID, section 13) and within CSR.
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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