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EC number: 232-304-6
CAS number: 8002-26-4
A complex combination of tall oil rosin and fatty acids derived from acidulation of crude tall oil soap and including that which is further refined. Contains at least 10% rosin.
2: BOD removal from the test flasks during the 28 day exposure
BOD Test substance
BOD Reference article
removal = BODtestsubstance
193.8 mg O2/L or 1.896 mg O2/mg test substance.
A Final Decision letter
(CCH-D-2114412576-50-01-F) was received for this substance on 09 July
2018 which requested further information on the PBT properties of the
Block 10 Aldehyde consituents in this substance. As a first step Abietal
was chosen to represent the Aldehyde Block 10 consituents and a ready
biodegradation study was comissioned and depending on the outcome of
that study the requirement for further testing for Persistence,
Bioaccumulation and Toxicity would not be required.
The results show that Abietal meets the
criteria in the OECD 301B to be labelled readily biodegradable e.g. at
least 60% biodegradation in 28 days. Meeting the 10-day window was not a
requirement according to both the ECHA Final Decision Letter and OECD
The test item is non-persistent, and
satisfies the criteria to be labelled readily biodegradable based on the
results obtained in the second experiment.
Abietal is representative of the Block 10
consituents and is therefore as it is readily biodegradable it is not
considered PBT or vPvB.
First, Abietal was put through a feasibility
study in which 3 different inoculum were tested. The objective of this
study was to evaluate the feasibility of the proposed adaptations, and
to determine the optimal experimental conditions to assess
biodegradability of Abietal (test item) in aerobic aqueous medium, with
inoculation using activated sludge, standardized soil, or a mixture of
these two. Adaptations are in accordance with OECD 301 B and/or
enhancements described in ECHA Guidance. The duration of the test was
extended to 42 days, which makes this an enhanced ready biodegradability
study, as described in ECHA Guidance.
The test item did
not meet the criteria to be classed as readily biodegradable under the
conditions of the test whilst using any of the tested inocula. However,
the study was conducted under the strict conditions of an OECD 301B
ready biodegradation test, while Abietal achieved significant ultimate
biodegradation across all inocula (>50 – 86% degradation) in less than
60 days. These results indicate that there is a strong potential for
Abietal to ultimately biodegrade rapidly in the environment and
therefore it may not have to be classified as persistent.
A full OECD 301B
study under GLP, with potential extension to 60 days, is proposed to
determine whether the substance can be classified as readily
biodegradable or if it can be classified as not persistent according to
the ECHA Guidance Chapter R.7b and R.11.
The objective of the study was to evaluate
test item Abietal for its ready or ultimate biodegradability in an
aerobic aqueous medium with microbial activity introduced by inoculation
with activated sludge.
In total, two experiments were performed.
The first experiment showed high test item variability. Therefore, the
experiment was repeated. The variability was confirmed to be test item
related in the second experiment. Since both experiments provide
valuable information to support the overall conclusion, both experiments
are reported in this report. With the exception of the difference
between replicate values, the study met the validity criteria prescribed
by the Study Plan and was considered to be valid.
47.9 % (19 % to 79 %) after 42 days. (Repeated due to high variability between replicates, significant degradation observed)
66.8 % (42 % to 104 %) after 48 days (non-persistent criteria met)
60.4 % (45 % to 83 %) after 28 days, with exclusion of replicate B (readily biodegradable criteria met)
No inhibition of microbial activity.
Formation of CO2was not observed in the abiotic controls
Abietal met the criteria to be classified as readily biodegradable.
The high rate of degradation observed in both experiments supports the conclusion that Abietal can be classified as non-persistent in accordance with the ECHA information requirements guidance R.11.
biodegradation value of 73.2% (measured
as percentage of theoretical oxygen demand) was achieved in 28 days
using a method consistent with OECD Guideline 301 F (manometric
respirometer) for Distilled Tall Oil (DTO).
Although, information about the 10-day window was not available, the
degradation rate is very rapid for a very poorly soluble substance. The
reference substance attained 92% degradation by Day 14 and percentage
degradation between replicate test samples was ± 20%, satisfying the
validity criteria of the test.
supporting studies, DTO was readily biodegradable in a GLP test
conducted according to OECD 301D (Closed Bottle Test) using an equal
volume mixture of three commercially available products. The substance
achieved significant levels of biodegradation (60% in 28 days) but
failed to meet the 10-day window. The biodegradability of a commercial
grade of DTO was measured in a GLP test according to OECD Guideline 301E
(Modified OECD Screening Test). The test medium comprised an aqueous
extract of the product, prepared by loading culture medium with 10 g/l
test substance and stirring for 23 hours, standing for 1 hours and
removing the aqueous extract by siphoning. The aqueous extract attained
64% degradation in 28 days.
assessment of biodegradability of the test substance is based on the
test conducted in accordance to OECD 301F because this is more
applicable to a poorly soluble substance like DTO. As
a whole, it can be concluded that DTO is readily biodegradable for
purposes of classification and labelling.
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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