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EC number: 224-292-6
CAS number: 4292-10-8
In a study conducted according to OECD Guideline 210 (Fish, Early-Life
Stage Toxicity Test) and EPA OPPTS 850.1400 (Fish Early-life Stage
Toxicity Test), the
100– day chronic toxicity of C8 -18 AAPB to early life stage of rainbow
trout (Oncorhynchus mykiss) was investigated under flow through
conditions and analytical monitoring of test material concentrations. The
mean recovery rates for all concentrations were in the range of 81 – 100
%. Therefore all effect values are based on nominal concentrations.
toxicity study is classified as reliable without restriction and
satisfies the requirements of the guideline..
Organism Size/Age: freshly fertilized eggs
Test Type: Flow-through
100 d-LOEC: 0.405 mg a.i./
0.135 mg a.i./l
Endpoint(s) Effected: egg hatch, length, dry weight, morphological and
behavioural effects, post hatch success and overall survival
One study for long-term toxicity to fish is available, investigating the 100– day chronic toxicity of C8 -18 AAPB conducted according to OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test).
life stage test as well as a prolonged 28-d toxicity study conducted
with C8-18 AAPB are available. An early life stage test with C12 AAPB is
ongoing; the dossier will be updated after the results are available.A
justification for read-across is given below.
In a study
conducted according to OECD Guideline 210 (Fish, Early-Life Stage
Toxicity Test) and EPA OPPTS 850.1400 (Fish Early-life Stage Toxicity
Test), the 100 day chronic toxicity of C8 -18 AAPB to early life stage
of rainbow trout (Oncorhynchus mykiss) was investigated under
flow through conditions and analytical monitoring of test material
concentrations. The mean recovery rates for all concentrations were in
the range of 81 – 100%. Therefore all effect values are based on nominal
concentrations. The 37 day NOEC and LOEC values, based on egg hatch,
were 0.135 and 0.405 mg a.i./L respectively. The 100 day overall NOEC
and LOEC values were 0.135 and 0.405 mg a.i./L, respectively. The
effects included were length, dry weight, morphological and behavioral
effects, post hatch success and overall survival.
data are available from a prolonged 28-d toxicity study conducted
according to OECD Guideline 215 Draft 'Juvenile growth test: 28 d'
(1992): Rainbow trouts (Oncorhynchus mykiss) were exposed to
C8-18 AAPB under flow through conditions. A 28-d NOEC = 0.16 mg a.i./L
nominal was determined based on growth (body length and mean body wet
weight). At higher test concentrations of 0.5 and 1.6 mg a.i./L nominal,
the growth rates could not be determined, since all fish died during the
obtained NOECs of 0.135 and 0.16 mg a.i./L of C8-18 AAPB were in the
same range. The obtained results were considered to be valid for the
The NOEC of
0.135 mg a.i./L obtained from the long-term study including early
life-stage was selected for further assessment and derivation of the
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 long-term fish toxicity data
Long-term toxicity to fish
key.Long-term toxicity to fish: 97862-59-4_220.127.116.11_THG_2008_OECD 210
OECD Guideline 210 (Fish, Early-Life Stage Toxicity Test)
Oncorhynchus mykiss, flow-through, freshwater
37 d NOEC = 0.135 mg/Lact. ingr. (nominal) based on: egg hatch
37 d LOEC = 0.405 mg/Lact. ingr. (nominal) based on: egg hatch
100 d NOEC = 0.135 mg/Lact. ingr. (nominal) based on: length, dry weight, morphological and behavioural effects, post hatch success, overall survival
100 d LOEC = 0.405 mg/Lact. ingr. (nominal) based on: length, dry weight, morphological and behavioural effects, post hatch success, overall survival
Reliability: 1 (reliable without restriction), GLP
No data, read-across
Sup.(prolonged fish test: 28 d).Short-term toxicity to fish.97862-59-4_9.1.3_IUA_1995_OECD_204
OECD Guideline 204 (Fish, Prolonged Toxicity Test: 14-day Study)
28 d NOEC = ca. 0.16 mg/L act. ingr. (nominal) based on: mortality
28 d LOEC = ca. 0.5 mg/L act. ingr. (nominal) based on: mortality
No deaths < 1.6 mg/L; 10/10 fish died within 4 d at >/= 1.6 mg/L
obtained NOECs of 0.135 and 0.16 mg a.i./L in both studies were in the
same range. The NOEC of 0.135 mg a. i./L obtained from the long-term
study including early life-stages was selected for further chemical
of the experimental data of the analogues:
available data are adequate and sufficiently reliable to justify the
study was conducted according toOECD
Guideline 210 (Fish, Early-Life Stage Toxicity Test; RL1, GLP). The
supporting study wasconducted
Guideline 204 (RL1,
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
AAPB are also valid for the target substance C12 AAPB.
The 100 d
NOEC of C8-18
AAPB to Oncorhynchus
0.135 mg a.i./L(nominal)
based on length, dry weight, morphological and behavioural effects, post
hatch success, overall survival.
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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