Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 938-645-3
CAS number: 1689515-39-6
A toxicokinetic assessment of a substance analogue (amphoacetates C8-C18) in accordance with the Guidance on information requirements and chemical safety assessment Chapter R.7c: Endpoint specific guidance was considered appropriate to assess the toxicokinetic properties of the substance. The absorption factors for risk assessment purposes: oral absorption 100%, inhalation absorption 100% and dermal absorption 10%.
Substance for which the toxicokinetic assessment is performed
Amphoacetates C12 -C14
Not yet assigned
(Alternate) CAS number(s)
66161 -62 -4; 68608 -66 -2
Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C11-C13 odd-numbered alkyl) derivs. and sodium hydroxide and chloroacetic acid
Reaction products of 1H-Imidazole-1-ethanol, 4,5-dihydro-, 2-(C7-C17 odd-numbered, C17-unsatd. alkyl) derivs. and sodium hydroxide and chloroacetic acid
Based on their structural similarity,
physico-chemical and toxicological properties, these 2 substances are
considered analogues. The
toxicokinetic properties of Alkylamidoamine glycinate were determined
based on the available physico-chemical properties and toxicological
In general, a compound needs to be dissolved
before it can be taken up from the gastro-intestinal tract after oral
administration. The relatively small molecular weight (between 367 and
446 for the different forms) and the high water solubility (1 kg/L) are
favourable for oral absorption. Because the substance has surface-active
properties and a complex composition with multiple constituents, a log
Kow could not be determined by the standard experimental methods.
However estimates showed a higher solubility in water than in n-octanol.
However, based on the moderate lipophilic character of the main
surfactant compound expected from the presence of a hydrophobic alkyl
chain structure Alkylamidoamine glycinate has the potential to be
absorbed by passive diffusion. In contrast, ionization of
Alkylamidoamine glycinate will impair the uptake since compounds need to
pass the lipid membranes in the gastrointestinal wall (Reference:,
Amidon GL. Mechanistic approach to understanding the factors affecting
drug absorption: a review of fundamentals. J Clin Pharmacol 2002; 42:
620-43). Overall, it is likely that Alkylamidoamine glycinate is
absorbed from the gastro-intestinal tract to a certain extent. Slight
variations observed in the liver weights and clinical chemistry in the
28-day repeated dose toxicity study provided some evidence of a
potential absorption by the oral route. For risk assessment purposes
oral absorption of Alkylamidoamine glycinate is set at 100%. The results
of the toxicity studies do not provide reasons to deviate from this
proposed oral absorption factor.
Once absorbed, distribution of the substance
throughout the body is expected based on its relatively low molecular
weight. Based on its relatively hydrophilic character, extracellular
concentration is expected to be higher than intracellular concentration.
Absorbed Alkylamidoamine glycinate might undergo conjugation. The
conjugates will either be excreted via the bile (high molecular weight
compounds) or the urine (low molecular weight compounds; Reference: ECB
EU Technical Guidance Document on Risk Assessment, 2003).
The boiling point could not be determined,
but decomposition starts at 160°C. Due to the relatively low vapour
pressure and since the substance is produced and used only as an aqueous
solution, it is not likely that Alkylamidoamine glycinate will reach the
nasopharyngeal region or subsequently the tracheobronchial or pulmonary
region. If Alkylamidoamine glycinate reaches the tracheobronchial
region, absorption through aqueous pores will be limited, taking the
molecular weight of > 200 into account. However, the high water
solubility of Alkylamidoamine glycinate (1 kg/L) is favourable for
dissolution of the substance in the mucus lining of the respiratory
tract. In addition, based on the structure of the main constituents and
the presence of hydrophobic and hydrophilic parts Alkylamidoamine
glycinate has the potential of crossing the alveolar and capillary
membranes by passive diffusion. If Alkylamidoamine glycinate is inhaled,
absorption of the substance is expected to be limited. For risk
assessment purposes the inhalation absorption of Alkylamidoamine
glycinate is set at 100%.
The substance has the potential to partition
from the stratum corneum into the epidermis, enhanced by the high water
solubility (1 kg/L). Due to the complexity of the UVCB substance and
presence of inorganic salt a realistic logKow value could not be
determined experimentally. However, the moderate lipophilic character of
the surfactant constituents with various lengths of a lipohilic alkyl
chain may indicate that the transfer between the stratum corneum and the
epidermis could occur for some of the constituents. As a first approach,
based on the molecular weight (between 367 and 446 for the different
forms of the major constituents), the criteria for 10% dermal absorption
as given in the TGD (Reference: ECB EU Technical Guidance Document on
Risk Assessment, 2003; MW > 500 and log Pow< -1 or > 4) are not met.
However, high water solubility and ionization state are expected to
influence significantly the dermal absorption potential. The presence of
charges has been shown to reduce dramatically the passage across the
skin (Reference: H. Schaefer, T. E. Redelmeier (eds). In: Skin Barrier –
Principles of percutaneous absorption.S. Krager AG (publ.), 1996). As
produced or under the use conditions the surfactant part of the
substance will be either as a sodium salt, or as an amphoteric form with
positive and negative charges, therefore less likely to be absorbed.
This is fully supported by experimental data on a structurally related
amphoteric surfactant, dodecylamidopropylbetaine (CAS# 4292-10-8)
showing a dermal absorption of less than 3.5% in Wistar rats (Reference:
HERA (Human and Environmental Risk Assessment on ingredients of
household cleaning products), 2005,
http://www.heraproject.com/RiskAssessment.cfm). This result is
considered relevant for the substance to propose a dermal absorption
factor of 10% for risk assessment purposes.
read-across from this analogue to the registered substance for the
dermal, oral and inhalation absorption factors of the substance is
considered scientifically justified based on the overall information
available (see Section 13 for the read across rationale).
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.
Welcome to the ECHA website. This site is not fully supported in Internet Explorer 7 (and earlier versions). Please upgrade your Internet Explorer to a newer version.
Do not show this message again