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EC number: 224-292-6
CAS number: 4292-10-8
Acute toxicity data from a study in marine sediment to the intertidal amphipod Corophium volutator are available. No long-term data are available. However, a long-term toxicity study on sediment organisms is not justified.
No data on
toxicity to sediment dwelling organism are available for C12 AAPB.
However, adequate and reliable short-term toxicity data on marine
sediment organisms are available for the closely related source substanceC8-18
and C18 unsatd. AAPB.
No data are
available for toxicity to freshwater sediment organisms.
toxicity of Coco AAPB to the intertidal amphipod Corophium
investigated in a study conducted according to OSPARCOM (1995) 'A
sediment bioassay using a amphipod Corophium sp.'. Corophium volutator
were exposed for 10 d under static conditions to the test item. The 10 d
NOEC and LC50 values were determined to be 14248 mg product/kg sediment
dw (5129 mg a.i./kg sediment dw) and >14248 mg product/kg sediment dw
(>5129 mg a.i./kg sediment dw nominal), respectively.
No data on
long-term toxicity to sediment-dwelling organisms are available. In
Annex IX of Regulation (EC) No 1907/2006, it is laid down that sediment
toxicity tests shall be proposed by the registrant if the chemical
safety assessment indicates the need to investigate further the effects
on sediment organisms. According to Annex I of this regulation, the
chemical safety assessment triggers further action when the substance or
the preparation meets the criteria for classification as dangerous
according to Directive 67/548/EEC or Directive 1999/45/EC or is assessed
to be a PBT or vPvB. The hazard assessment of AAPB reveals neither a
need to classify the substance as dangerous to the environment, nor is
it a PBT or vPvB substance, nor are there any further indications that
the substance may be hazardous to the environment. Furthermore, the
substance is not persistent in this compartment, due to physico-chemical
properties and the proven rapid biodegradability. Therefore, a long-term
toxicity study on sediment organisms is not justified.
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
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 ecotoxicity of the AAPBs could potentially arise from the following
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
ecotoxicity 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 ecotoxicity.
C8-18 and C18 unsatd. AAPB
key (marine).Sediment toxicity.61789-40-0_9.5.1_Marine_10d_Corophium volutator_Rhodia_Mirataine-BET-C-37_2008
OSPARCOM guidelines (1995) A sediment bioassay using a amphipod Corophium sp.
Corophium volutator, short-term toxicity, static
10 d NOEC = 14248.1 mg/kg sediment dwtest mat. (nominal) based on: mortality
10 d NOEC = 5129 mg/kg sediment dwact. ingr. (nominal) based on: mortality
10 d LC50 > 14248.13 mg/kg sediment dwtest mat. (nominal) based on: mortality
10 d LC50 > 5129 mg/kg sediment dwact. ingr. (nominal) based on: mortality
Reliability: 1 (reliable without restriction), GLP
No data, read-across
The 10 d
LC50 exceeded the highest tested concentration of5129
mg a.i./kg sediment dw. No effects were observed at any concentration
of the experimental data of the analogues:
available data are adequate and sufficiently reliable to justify the
was performed according toOSPARCOM
guidelines and was reliable without restrictions (RL1, GLP).
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, it can be concluded that the available data from the source
and C18 unsatd. AAPB are also valid for the target substance C12 AAPB.
The 10 d
NOEC and LC50 values ofC8-18 and C18 unsatd. AAPB to Corophium
determined to be 5129 mg a.i./kg sediment dw (nominal) and >5129 mg
a.i./kg sediment dw (nominal), respectively.
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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