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EC number: 814-283-0
CAS number: 42220-47-3
test item does not indicate a potential for bioaccumulation based on its
physical-chemical properties and available experimental data.
analysis of Phosphonic acid, (1-hydroxyethylidene)bis-, compd. with
are no studies available that experimentally investigated the
toxicokinetic behaviour of the test item. Therefore, based on the
molecular structure of its constituents and the test items
physicochemical properties a toxicokinetic assessment is performed
(please also refer to respective disseminated information of REACH
Registration dossiers on ECHAs website for Etidronic acid (CAS 64-18-6)
and 2-ethanolamine (monoethanolamine, MEA, CAS 141-43-5), respectively).
test item is an organic multi-constituent substance appearing as white
solid with tiny read spots on the surface, homogenously consisting of
solid and liquid parts at ambient conditions. The mean molecular weight
of the test item is 267.11 g/mol with a relative density of 1.532 at 20
°C. Melting point of the substance was determined to start at about
ambient temperature ranging up to about 116 °C with a peak temperature
at 81 °C. A normal boiling point could not be determined. At a pressure
of 3000 hPa the boiling temperature was determined to be 92.9 °C. Vapour
pressure was 15.6 hPa at 20 and 20.4 hPa at 25 °C. The test item is well
soluble in water as indicated by solubility of > 70.5 g/100 and < 79.9
g/100g. The n-octanol/water partition coefficient was estimated to be <
of the test item in the intestine is expected based on its good water
solubility and low molecular weight of the two main constituents (ECHA
guidance R7c Table R.7.12-1). Even though, the logPow being < -5 is not
within the favourable range for passive diffusion. The ingested
phosphonic acid derivate as well as 2-ethanolamine is anticipated to at
least partially dissociate in contact with gastrointestinal fluids. The
small ionic structures formed may then be easily absorbed by aqueous
pores or other carrier structures by means of bulk passaging water (ECHA
guidance R7c, 2017).
absorption of the test item via the GIT is well shown by the Combined
Repeated Dose Toxicity Study with the Reproduction/Developmental
Toxicity Screening Test according to OECD 422 (BASF, 2018). Systemic
effects were observed at the mid and high dose group (600 and 2000/1000
mg/kg bw/d), which indicates that the test item becomes bioavailable via
the oral route.
behaviour of the constituent 2-ethanolamine was comprehensively
investigated (please refer to disseminated dossier data on ECHA´s
website). Topically applied it penetrates the skin very well. Thus,
bioavailability via the GIT and the respiratory tract is considered
likely as well.
second constituent, etidronic acid, however, was found to be not well
absorbed (less than 10 %).
to the test item and thus also absorption via the inhalation route
cannot be ruled out based on the volatile character of the test item
(vapor pressure 15.6 hPa).
on systemic findings in the repeated dose toxicity study the test item
is expected to be widely distributed through the body. Since the logPow
of the test item is very low and does not exceed a value of 4
bioaccumulation is not anticipated (ECHA guidance R7c). The constituent
2-ethanolamine is an endogenously present molecule which is integrated
in biosynthesis of phosphoglycerides of biological membranes. Therefore,
incorporation mechanisms in cells of liver and kidney are assumed.
Regarding the second constituent, phosphonic acid derivate, an expected
absorption in bones at considerable amounts was not confirmed based on
disseminated data on respective REACH Registration Dossier.
etidronic acid no metabolites could be identified. Upon absorption, this
constituent does probably not undergo further oxidation reactions by
Phase I Cytochrome P450 enzymes. It is rather expected to be a potential
substrate for phase II conjugation reactions such as glucuronidation or
contrast, extensive metabolism of 2-ethanolamine was indicated by the
incorporation of radiolabelled carbon into hepatic amino acids, proteins
and phospholipids. Urea and glycine were the major urinary metabolites
is an endogenous breakdown product of cell membrane phospholipid
phosphatidyl EA and commonly found in the gastrointestinal tract
(Garsin, 2012). Thus,
the substance may not be readily excreted but likely reabsorbed and
utilized within endogenous anabolic pathways. Excretion of phosphonic
acid derivate occurs slowly via the urine.
no toxicokinetic data are available on the test item, there are no
remaining uncertainties. Based on physico-chemical properties supported
by experimental observations and information available on the two main
constituents, the test item is expected to be absorbed via the oral,
dermal and inhalation route. From observations in the OECD 422 main
study with the test item it is concluded that at least a fraction is
absorbed via the oral route. The observed systemic effects indicate a
wide distribution of the components throughout the body. Based on the
small molecular size of the two main constituents and their well
solubility in water excretion via urine is most likely. Extensive
metabolism of 2-ethanolamine is anticipated.
on the available data it can be concluded that the test item becomes
bioavailable via the oral, dermal and inhalation route. It is further
readily distributed among body compartments. Metabolic conversion is
expected. Excretion is mainly accomplished via the urine. The test item
does not indicate a potential for bioaccumulation based on its
physical-chemical properties and available experimental data.
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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