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EC number: 253-462-2
CAS number: 37321-62-3
For detailed information on the results please refer to the attached
The temperature exceeded 24 °C on one day of the test. This has not
affected the outcome of the study since the biodegradation of the
reference substance was normal.
Table 1: Biodegradation (%) of test substance (TS) and reference
The chemical oxygen demand (COD) was defined using the Kelkenberg-method
but there are indicators that is was not defined well (compared to the
calculation of the theoretical oxygen demand (ThOD)). Anyway the COD was
used for calculation.
According to “OECD Guidelines for the testing of chemicals –
Revised introduction to the OECD guidelines for testing of chemicals,
Section 3 – Part 1: Principles and strategies related to the testing of
degradation of organic chemicals degradation” published by OECD (2006)
the ready biodegradability data
for mixtures of
structurally similar chemicals should be evaluated carefully.
For substances with different chain lengths the 10-day window should not
be used for the interpretation of results. It is possible that a
sequential biodegradation took place which might have led to a prolonged
lag-Phase and therefore a slower biodegradation period although the test
substance was biodegraded in a large amount after the test duration. In
this case the pass level can be applied at 28 days and is therefore
readily biodegradable (61% after 28 days).
Readily biodegradable: ≥60% in 28 days
The hazard assessment is based on the currently available data.
New studies with the registered substance and/or other member substances
of the glycol esters category will be conducted in the future. The
finalised studies will be included in the technical dossier as soon as
they become available and the hazard assessment will be re-evaluated
For further details, please refer to the category concept document
attached to the category object (linked under IUCLID section 0.2)
showing an overview of the strategy for all substances within the glycol
The biodegradability of dodecanoic acid, ester with 1,2-propanediol (CAS
37321 -62 -3) was assessed in the frame of a weight of evidence using
read-across data from the structurally similar source substances
decanoic acid, mixed diesters with octanoic acid and propylene glycol
(CAS 68583-51-7) and Fatty acids, C16-18, esters with ethylene glycol
(CAS 91031-31-1) as well as appropriate QSAR calculations for the two
main constituents of the substance.
Read across was performed in accordance with Regulation (EC) No
1907/2006 Annex XI, 1.5. The source substances are characterized by
similar fatty acid chain lengths as well as alcohol components and are
therefore considered suitable representatives for the assessment of the
biodegradability of the target substance. Both studies were performed
according to international accepted guidelines and GLP.
The study with the read across substance decanoic acid, mixed diesters
with octanoic acid and propylene glycol (CAS 68583-51-7) was conducted
according to the EU Method C.4-C (GLP) under aerobic conditions using
domestic activated sludge as inoculum (1995). A mean biodegradation of
82% was recorded after 28 d. The substance reached the biodegradation
pass level of > 60% within the 10-day window and therefore considered as
readily biodegradable. Similar results were obtained from the study with
the second read across substance Fatty acids, C16-18, esters with
ethylene glycol (CAS 91031-31 -1). The biodegradability was evaluated
according to an international guideline (ISO 10708) and GLP (1998).
Non-adapted activated sludge from a domestic sewage treatment plant was
used as inoculum. The test substance, which was applied at a
concentration of 100 mg/L was degraded to an extent of 61% (O2
consumption) after 28 d and 75% after 56 d. Since the substance reached
the pass level of biodegradation of > 60%, it is considered readily
biodegradable according to international guideline criteria.
The biodegradability of the two main constituents (monoester and diester
of dodecanoic acid, ester with 1,2-propanediol) of the substance was
furthermore assessed using the QSAR model on ready biodegradability
(v1.0.9) incorporated within the VEGA software (v1.1.4). The model is
considered appropriate for the evaluation of the biodegradability of the
constituents with strongly similar substances in the training set and
the results are adequate and reliable for assessment. Both constituents
were predicted to be readily biodegradable, which is in line with the
results given by the analogue substances.
Based on the results of the read across substances and the QSAR
predictions, the target substance dodecanoic acid, ester with
1,2-propanediol (CAS 37321 -62 -3) is considered readily biodegradable.
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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