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EC number: 224-292-6
CAS number: 4292-10-8
Data from a study conducted according to OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test) are available.
experimental data are available for C12 AAPB. However, adequate and
reliable data on the short-term toxicity to terrestrial plants are
available for the closely related source substance C8-18 and C18 unsatd.
justification for read-across is given below.
In a study
(limit test) conducted according to OECD Guideline 208 (Terrestrial
Plants Test: Seedling Emergence and Seedling Growth Test),Triticum
aestivum,Brassica alba and Lepidium
exposed to a nominal concentration of 100 mg Coco AAPB/kg soil. A 17
d-NOEC ≥100 mg dry residue/kg soil d.w. nominal (= 84.6 mg a.i./kg) was
determined for all three plant species in respect to emergence and
growth. Analytical monitoring was not performed.
recommended in R.188.8.131.52, data obtained from the OECD 208 Guideline
study have been used as estimates of chronic toxicity as they cover a
sensitive stage in the life-cycle of a plant. The determined NOEC of
84.6 mg/kg (a.i. nominal) was used for PNEC derivation. In addition
according to REACH Regulation (Annex X, 9.4, column 2), a study on
long-term toxicity on terrestrial organisms does not need to be
conducted if no direct or indirect exposure of soil is to be expected.
Based on the uses of the test substance, soil is not the target
compartment and therefore exposure of soil is expected to be low and
furthermore the test substance proved to be readily biodegradable.
Therefore additional testing is considered not necessary.
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.
of toxicity datato
C8-18 and C18 unsatd. AAPB
Toxicity to terrestrial plants
key.Toxicity to terrestrial plants: 61789-40-0_9.4.3_Hüls_1995_OECD 208
OECD Guideline 208 (Terrestrial Plants Test: Seedling Emergence and Seedling Growth Test),Triticum aestivum, Lepidum sativum, Brassica albaseedling emergence toxicity test, short-term toxicity, laboratory study
17 d NOEC >= 100 mg/kg soil dw,dry residue (nominal) based on: emergence and growth17 d NOEC >= 84.6 mg/kg soil dw,act. ingr. (nominal) based on: emergence and growh
Reliability: 2 (reliable with restrictions), GLP
No data, read-across
d-NOEC>=100 mg dry residue/kg soil d.w. nominal (=84.6 mg a.i./kg soil
dw; growth, emergence) was determined for all three plant species in a
study conducted according to OECD Guideline 208.
of the experimental data of the analogues:
available data are adequate and sufficiently reliable to justify the
wasperformed according to OECD Guideline 208and
wasreliable with restrictions (RL2, 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
substance C8-18 and C18 unsatd. AAPBare
also valid for the target substance C12 AAPB.
The 17 d
NOEC was 84.6 mg a.i./kg soil dw (based
on seedling emergence and growth)
in the tested speciesTriticum
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