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EC number: 224-292-6
CAS number: 4292-10-8
- readily biodegradable under aerobic and
- ultimately biodegradable
in the marine environment
readily biodegradable, biodegradable under anaerobic conditions and
under different environmental conditions (water, seawater, sewage
treatment plants). The ultimate biodegradation was proven and a mean
elimination of 99 % was calculated. Therefore further investigation on
biodegradation in soil does not need to be conducted in accordance with
REACH Regulation Annex IX, 18.104.22.168.
results from several guideline studies (e.g. OECD 301 A, 301 B, 301 D,
301 E) on the aerobic biodegradation of Coco AAPB, C12 AAPB and C8 -18
AAPB are available. Based on the results, Coco AAPB, C12 AAPB, and C8
-18 AAPB can be regarded as readily biodegradable. The inherent
biodegradability of C12-18 AAPB was proven in a Zahn-Wellens Test. Based
on these results, the AAPBs can be regarded as readily biodegradable.
anaerobic biodegradability of Coco AAPB and C8-18 AAPB was investigated
in studies conducted similar to OECD guideline 311. Based on the results
of these studies, the AAPBs are considered to be biodegradable under
the ultimate biodegradation of the AAPBs was proven; a mean elimination
of 99% was calculated for the AAPBs. Based on the results of the
biodegradation study in seawater, the AAPBs are considered as readily
biodegradable in the marine environment.
on substance identity and detailed (eco)toxicological profiles, please
refer also to the general justification for read-across given at the
beginning of the CSR and attached as pdf document to IUCLID section 13.
read-across approach is justified based on structural similarities. All
AAPBs contain the same functional groups. Thus a common mode of action
can be assumed.
deviation within this group of substances is a minor variety in their
fatty acid moiety (chain length and degree of unsaturation), which is
not expected to have a relevant impact on intrinsic ecotoxicological
in several biodegradation screening tests ready or at least inherent
biodegradability was shown for all substances under invesitigation.
Structural similarity and functional groups
betaines (AAPBs) are – with the exception of C12 AAPB - UVCB substances
(Substances of Unknown or Variable composition, Complex reaction
products or Biological materials), which are defined as reaction
products of natural fatty acids or oils with dimethylaminopropylamine
and further reaction with sodium monochloroacetate. AAPBs are amphoteric
surfactants, which are characterized by both acidic and alkaline
general structure is:
R = fatty
acids have a mixed, slightly varying composition with an even numbered
chain length from C8 to C18. Unsaturated C18 may be included.
Consequently, the AAPBs differ by their carbon chain length distribution
and the degree of unsaturation in the fatty acid moiety. However,
Lauramidopropyl betaine (C12 fatty acid derivate) is the major
ingredient of all AAPBs covered by this justification as listed in table
1 “Substance identities” of the general justification for read-across.
substances under evaluation share structural similarities with common
functional groups (quaternary amines, amide bonds and carboxymethyl
groups), and fatty acid chains with differences in chain length and
degree of saturation.
in acute toxicity of the AAPBs could potentially arise from the
amounts of different carbon chain lengths (carbon chain length
amounts of higher chain lengths and corresponding lower amounts of lower
chain length could result in a rising average lipophilicity. However,
the main component for all AAPBs is C12 AAPB. Relevant effects on
biodegradability are not to be expected.
amounts of unsaturated fatty ester moieties:
be expected for e.g. physical state, but are not considered to be of
relevance for biodegradability.
of biodegradation data
C8-18 and C18 unsatd. AAPB
(further supporting studies are presented in the General Justification for Read-Across)
key.Biodegradation in water: screening tests: 63641-59-8_22.214.171.124a_Hoechst_1986_OECD 302B
equivalent to OECD TG 302 B (Zahn-Wellens/EMPA Test), inherent biodegradability, aerobic
activated sludge, industrial, non-adapted
% Degradation of test substance:89.4 after 15 d (DOC removal)
Reliability: 2 (reliable with restrictions), no GLP
key.Biodegradation in water: screening tests.97862-59-4_126.96.36.199_EOC_Hydrotox_1992_OECD 301 B
OECD Guideline 301 B (Ready Biodegradability: CO2 Evolution Test), ready biodegradability, aerobic
activated sludge (adaptation not specified)
% Degradation of test substance: 91.6 after 28 d (CO2 evolution)
Reliability: 1 (reliable without restriction), GLP
key.Biodegradation in water: screening tests.61789-40-0_188.8.131.52_Stepan_2000_ISO/DIS 14593
ISO/DIS 14593, ready biodegradability, aerobic
% Degradation of test substance: 87.2 after 28 d (CO2 evolution)
Reliability: 1 (reliable without restriction), no GLP
key.Biodegradation in water: screening tests.4292-10-8_184.108.40.206_DAC_1996_EEC 92-69 C4f
EU Method C.4-F (Determination of the "Ready" Biodegradability - MITI Test), ready biodegradability, aerobic
inoculum taken from a purifying plant for municipal and industrial effluents, from an industrial effluent purifying plant and surface water and surface soil from a river bank
% Degradation of test substance:82 after 28 d (O2 consumption) (biodegradation based on ThOD)
95 after 28 d (O2 consumption) (biodegradation based on COD)
key(anaerobic)_Biodegradation in water: screening tests: 97862-59-4_9.3.4_THG_2000_ECETOC TG 28
ECETOC Anaerobic Biodegradation (Technical Report No. 28),anaerobic biodegradability
% Degradation of test substance:
ca. 80 after 62 d (DOC removal)
well biodegradable under anaerobic conditions
key (anaerobic).Biodegradation in water: screening tests: 61789-40-0_9.3.4_Colgate-Palmolive_2002_ISO 11734
ISO 11734,anaerobic biodegradability
80 — 90 after 60 d (biogas production and TIC)
biodegradable under anaerobic conditions
Biodegradation in water and sediment: simulation tests
key(seawater).Biodegradation in water and sediment: simulation tests.61789-40-0_9.2.1_Stepan_2007_JC_OECD 306-CONF
similar to OECD Guideline 306 (Biodegradability in Seawater),aerobic
% Degradation of test substance:76 after 28 d (O2 consumption)
Reliability: 2 (reliable with restrictions), GLP
No data, read-across
WoE.Biodegradation in water and sediment: simulation tests.61789-40-0_220.127.116.11_Biodeg_Unilever_A20_TR-474-01
weight of evidence
similar to OECD Guideline 303 A (Simulation Test - Aerobic Sewage Treatment. A: Activated Sludge Units), aerobic
% Degradation of test substance: 96.8 — 105.2 after 161 d (DOC removal)
WoE.Biodegradation in water and sediment: simulation tests: 61789-40-0_18.104.22.168_Henkel_2001_OECD 303A
OECD Guideline 303 A (Simulation Test - Aerobic Sewage Treatment. A: Activated Sludge Units), aerobic
% Degradation of test substance: 97 after 35 d (DOC removal)
sup(seawater).Biodegradation in water and sediment: simulation tests.61789-40-0_9.2.1_Stepan_2003_JC_OECD 306-CONF
similar to OECD Guideline 306 (Biodegradability in Seawater), aerobic
% Degradation of test substance: 54 after 28 d (O2 consumption)
C8-18 and C18 unsatd. AAPB and C12 AAPB were shown to be readily
biodegradable under aerobic conditions. For C8-18 AAPB as well as C8-18
and C18 unsatd. AAPB the biodegradation under anaerobic conditions was
proved as well.
C18 unsatd. AAPB was shown to be ultimately biodegradable in seawater as
well as in a simulation test with seage.
of the experimental data of the analogues:
available data are adequate and sufficiently reliable to justify the
were performed according to or similar toguidelines
and werereliable or reliable with restrictions (RL1-2).
materials used in the respective studies represent the source substance
as described in the hypothesis in terms of substance identity and minor
the study results are adequate for the purpose of classification and
labelling and risk assessment.
structural similarities of the target and source substancesas
presented above and in more detail in the general justification for read
across as well ason
the similar results from the screening tests,
it can be concluded that the available data on ultimate biodegradation
from the source substance C8-18 and C18 unsatd. AAPBare
also valid for the target substance C12 AAPB.
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