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EC number: 308-783-3
CAS number: 98510-75-9
Oral:-LD50 > 2000 mg/kg bw (based on test material) / LD50 > 830 mg a.i./kg bw; OECD TG 423, rat (female) oral: gavage (RL1, GLP); read-across: Formamidopropylbetaine-LD50 = 2335 mg a.i./kg bw; Similar to OECD TG 401, standard acute method, rat oral: gavage (RL1; pre-GLP); read-across: C8-18 and C18 unsatd. AAPBDermal:-LD50 > 2000 mg a.i./kg bw; OECD TG 402, rat, Type of coverage: Occlusive (RL1, GLP); read-across: Formamidopropylbetaine-LD50 > 2000 mg/kg bw (based on test material) / LD50 > 620 mg a.i./kg bw; OECD TG 402, rat, Type of coverage: Occlusive (RL1, GLP); read-across: C8-18 and C18 unsatd. AAPBInhalation-No relevant route of exposure
experimental data are available for the target substance Undecylenamidopropyl
Betaine. However, acute oral and dermal toxicity studies are available
for the closely related source substances C8-18
and C18 unsatd. AAPB (Coco AAPB) and Formamidopropylbetaine. A
justification for read-across is given below.
an acute oral toxicity study according to US Guideline Appraisal of the
Safety of Chemicals in Food, Drugs and Cosmetics, FDA, 1959, which is
comparable to the OECD guideline 401 (1981), 5 male and 5 female Wistar
rats were given a single oral dose of Coco AAPB (30 % a.i.) as delivered
by the sponsor at doses of 5.0, 6.3, 7.94, and 10.0 mL/kg bw. Animals
were then observed for 14 days.
5.0, 6.3, 7.94, and 10.0 ml/kg bw 2/10, 2/10, 6/10, and 8/10 animals
died, respectively. Most animals died within 24 hours p.a.. Weight gains
were normal in all animals. Clinical signs at >= 5 mL/kg bw were
decreased motor activity, coordination disturbances, abnormal body
posture, piloerection, diarrhoea, skin/mucosa cyanosis and decreased
body temperature with dose response relationship. At >= 7.94 mL/kg bw
animals showed prone position. Clinical signs were observed at 20
minutes, 1 h and 3 h after application. Except of slight diarrhoea in
one animal in dose groups 6.3, 7.94 and 10 mL/kg bw, each, all symptoms
were reversible after 24 hours. 7 days after application, all surviving
animals were free of clinical symptoms. Gross pathology examination of
animals found dead revealed reddened gastric and intestinal mucosa.
Animals sacrificed at study termination 14 days p.a. had light reddened
LD50 Combined = 7.45 mL/kg bw after 14 d
LD50 Combined = 8.1 mL/kg bw after 24 h
determined refers to the test substance as delivered by the sponsor.
There is no information on content of active ingredient of the test
substance in the study report. However, according to producer
information tested Coco AAPB has 30% active ingredient. The density is
roughly 1 g/mL. Therefore, the calculated oral LD50 combined referring
to 100% active substance = 2335 mg/kg bw after 14 d.
AAPB is of low toxicity based on the LD50 in males and females.
an acute oral toxicity study according to according to the OECD
Guideline for the Testing of Chemicals No. 423 "Acute Oral Toxicity -
Acute Toxic Class Method” 6 female Wistar rats were given a single dose
of Formamidopropylbetaine (50% based on solid matter, active matter:
test substance was applied by gavage undiluted and as 10% (w/w) solution
in tap water. No toxic symptoms after administration of 300 mg/kg body
weight were observed in six animals. In the next step the test substance
was applied to six rats at a dose level of 2000 mg/kg body weight. No
toxic symptoms were observed in this group, as well. No death occurred
in all groups of the dose levels 300 mg/kg and 2000 mg/kg body weight.
Body weight development of all animals was positive 7 days and 14 days
post application. The necropsy 14 days after oral application showed no
substance related morphological visible pathologic organ findings. Thus,
the LD50-value for the test substance is higher than 2000 mg/kg bw,
corresponding to > 830 mg/kg bw in terms of active substance.
on these results, the oral LD50 of the target substance Undecylenamidopropyl
considered to be >2000 mg/kg bw.
an acute dermal toxicity study according to EU Method B.3 and OECD
Guideline 402, 5 male and 5 female CD rats (Crl:COBS CD(SD)BR) were
dermally exposed to Coco AAPB (a.i 31 %) as delivered by the sponsor for
24 hours to 10% of total body surface at a dose of 2000 mg/kg bw (limit
test). Test sites were covered with an occlusive dressing. After 24
hours, the test sites were rinsed with warm water. Animals then were
observed for 14 days after dosing.
were no clinical signs of systemic reaction to treatment. Sites of
application of the test substance showed slight or well-defined erythema
in all animals on Day 2 and/or 3. On Day 4 and Day 5, slight erythema
were seen in three male and four female rats, sloughing in two male rats
and one female rat and hyperkeratinisation in three female rats. All
skin reactions were completely reversible by Day 6 in all animals.
Slightly low bodyweight gains were recorded for three females on Day 8.
All other rats achieved anticipated bodyweight gains throughout the
study. Terminal autopsy findings were normal.
LD0 Combined: 2000 mg/kg bw
LD50 Combined: > 2000 mg/kg bw
and LD50 determined refer to the test substance as delivered by the
sponsor. Amount of active ingredient in test substance is 31 %.
Therefore the calculated oral LD0and LD50 combined referring to 100 %
active substance is 620 and > 620 mg/kg bw, respectively.
AAPB (a.i. 31 %) is of low toxicity based on the LD50 in males and
an acute dermal toxicity study according to OECD Guideline 402 (1987)
"Acute Dermal Toxicity" and EC, Council Directive 67/548/EEC, Annex V,
B.3 (1992) Formamidopropylbetaine was administered to five Wistar rats
of each sex by a single dermal application at 2000 mg/kg body weight for
24 hours. Animals were subjected to daily observations and weekly
determination of body weight. Macroscopic examination was performed
after terminal sacrifice (day 15). No mortality occurred,
Chromodacryorrhoea was noted among the animals on days 1 and 2, Scales
were seen in the treated skin-area of some animals between days 3 and
12. The body weight gain during the observation period was within the
range expected for rats used in this type of study. No abnormalities
were found at macroscopic post mortem examination of the animals. The
dermal LD50 value of Formamidopropylbetaine in Wistar rats was
established to exceed 2000 mg/kg body weight (corrected for purity of
the test substance).
on these results, the dermal LD50 of the target substance Undecylenamidopropyl
considered to be >2000 mg/kg bw.
toxicity studies by inhalation route are unjustified. Due to its very
low vapour pressure, an exposure to Undecylenamidopropyl
is negligible. Generation of aerosols may be theoretically possible,
however the estimated exposure is very low. Furthermore, systemic
toxicity relevant to humans did not appear neither in acute nor in
repeated dose toxicity studies by other exposure routes. Considering the
exposure probability and the available information on the intrinsic
toxic activity of the substance, an inhalative risk to humans is
unlikely and therefore, conduct of an inhalative toxicity study is
is no evidence on relevant intrinsic acute toxic activity of Undecylenamidopropyl
a hazard to human health. The acute toxicity of closely related source
substance in rats was demonstrated to be low, with a dermal LD50 > 2000
mg/kg bw, and an oral LD50 value of 2335 mg/kg bw.
are no data gaps for the endpoint acute toxicity. No human data are
available. However, there is no reason to believe that these results
from rat would not be applicable to humans.
details on substance identity and detailed 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
read-across approach is justified based on structural similarities. The
target and source substances contain the same functional groups. Thus a
common mode of action can be assumed.
only deviation within this group of substances is a variety in their
carbon chain length, which obviously does not have a relevant impact on
acute toxicity as demonstrated by the available data on the source
similarity and functional groups
target substance Undecylenamidopropyl
a monoconstituent substance manufactured from undecylenic acid
N-dimethylpropylenediamine (DMAPA) and
further reacted with monochloroacetic acid.
source substance C8-18
and C18 unsatd. AAPB is a UVCB
natural fatty acids or oils with N,
N-dimethylpropylenediamine (DMAPA) and
further reacted with sodium monochloroacetate. As their origin is from
natural sources, the used fatty acids may have a mixed slightly varying
composition with an even numbered chain length from C8 to C18, including
unsaturated C18 chains.
source substance Formamidopropylbetaine is
a monoconstituent substance manufactured from formic
N-dimethylpropylenediamine (DMAPA) and further
reacted with sodium monochloroacetate.
in chemical and other intrinsic properties of the target and source
substances could potentially arise from the following facts:
amounts of different carbon chain lengths (carbon chain length
amounts of higher chain lengths and corresponding lower amounts of lower
chain length lead to a rising average lipophilicity as can be seen from
the increasing log Kow from Formamidopropylbetaine (log Kow: -3.3), Undecylenamidopropyl
Kow: -1.38), C12 AAPB (log Kow: 3.54), C8-18
and C18 unsatd. AAPB (log
from Formamidopropylbetaine and C8-18 and C18 unsatd. AAPB
considered to be appropriate to fulfil the information requirements for
acute oral and dermal toxicity.
Different amounts of unsaturated fatty ester moieties:
source substance C8-18
and C18 unsatd. AAPB contains considerable amounts of unsaturated C18
chains, which represents a worst case with respect tosome
toxicological endpoints, mainly local effects (e.g. irritation,
provided structural similarities and impurity profiles support the
proposed read-across hypothesis with high confidence.
of acute toxicity data
C8-18 and C18 unsatd. AAPB
Acute toxicity, oral
WoE_RA_LTOE 16396 Acute toxicity: oral
OECD TG 423, rat (female) oral: gavage
LD50 > 2000 mg/kg bw (based on test material)
LD50 > 830 mg a.i./kg bw
Reliability: 1 (reliable without restrictions), GLP
No data, read-across
WoE_RA_Acute toxicity: oral: 61789-40-0_8.5.1_Th_Goldschmidt_AG_1977
Similar to OECD TG 401, standard acute method, rat oral: gavage
LD50 = 7.45 mL/kg bw (based on test material; after 14 d)
LD50 = 2335 mg a.i./kg bw (after 14 d)LD50 = 8.1 mL/kg bw (based on test material; after 24 h)LD50 = 2430 mg a.i./kg bw (after 24 h)
Reliability: 1 (reliable without restrictions), pre-GLP
Acute toxicity, dermal
WoE_RA_NOTOX 454027 Acute toxicity: dermal
OECD TG 402, rat, Type of coverage:
LD50 > 2000 mg a.i./kg bw
WoE_RA_Acute toxicity: dermal: 61789-40-0_8.5.3_KAO Corporation_1987_OECD 402
LD0 > 2000 mg/kg bw (based on test material)LD0 > 620 mg a.i./kg bwLD50 > 2000 mg/kg bw (based on test material)
LD50 > 620 mg a.i./kg bw
is no evidence of relevant intrinsic acute toxicity of the source
oral LD50 of C8-18 and C18 unsatd. AAPB was
2335 mg a.i/kg bw in rat.
oral LD50 of Formamidopropylbetaine was >
2000 mg/kg bw (based on test material), corresponding to LD50 > 830 mg
C8-18 and C18 unsatd. AAPB has
only been tested at 620 mg a.i./kg bw (corresponding to 2000 mg/kg bw in
terms of test material) via the dermal route, the consideration of all
available data on acute dermal toxicity, acute oral toxicity,
toxicokinetics and dermal penetration leads to the conclusion, that the
dermal LD50 will be > 2000 mg a.i./kg bw.
is supported by the dermal LD50 of Formamidopropylbetaine of > 2000 mg a.i./kg bw
source substances Formamidopropylbetaine
C8-18 and C18 unsatd. AAPB represent
both extremes with shorter and longer C-chains compared to the target
and C18 unsatd. AAPB also
contains higher amounts of unsaturated fatty acid chains. Interpolation
is judged to be appropriate to fulfil the information requirements for
of the experimental data of the analogues:
available data are adequate and sufficiently reliable to justify the
acute oral toxicity of C8-18 and C18 unsatd. AAPB was tested in a study
similar to OECD Guideline 401 (RL1, study performed before
implementation of GLP). The acute oral toxicity of
Formamidopropylbetaine was tested in a study according to OECD
Guideline 423 (RL1, GLP).
acute dermal toxicity of C8-18
and C18 unsatd. AAPB as well as Formamidopropylbetaine was tested in a
study according to OECD
Guideline 402 (RL1, GLP).
test materials used in the respective studies represent the source
substance as described in the hypothesis in terms of substance identity
and minor constituents.
the study results are adequate for the purpose of classification and
labelling and risk assessment.
on structural similarities of the target and source substances as
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 and Formamidopropylbetaine are also valid for the
target substance Undecylenamidopropyl
is no evidence of relevant intrinsic acute toxicity of Undecylenamidopropyl
thus, classification and labelling with regard to acute toxicity is not
on the available data, Undecylenamidopropyl
not need to be classified for acute toxicity according to regulation
(EC) 1272/2008. Thus, no labelling is required.
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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