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Toxicokinetic analysis of Acetic acid,
oxo-, sodium salt, reaction products with 2-aminoethanol and phenol,
sodium hydroxide and iron trichloride (MEAHA-Fe)
MEAHA-Fe is a fine grained, homogeneous
solid at room temperature. The molecular weight of the main constituent
(C10H11NO4Fe(OH)(H2O)) is 300.094 g/mol. The substance is highly soluble
in water (≥50 g/L). The log Kow of MEAHA-Fe was estimated from its
solubilities in water and n-octanol to be < -1.5. Based on this log Kow,
it is predicted that MEAHA-Fe has low potential for bioaccumulation.
MEAHA-Fe has a low vapour pressure of < 0.0015 Pa at 20°C. MEAHA-Fe is
not readily (bio)degradable.
Oral absorption is favoured for molecular
weights below 500 g/mol. Based on the high water solubility and the low
log Kow value, Acetic acid, oxo-, sodium salt, reaction products with
2-aminoethanol and phenol, sodium hydroxide and iron trichloride
(MEAHA-Fe) is expected to be too hydrophilic to be readily absorbed via
the GI tract, but may be taken up by passive diffusion. Absorption of
very hydrophilic substances by passive diffusion may be limited by the
rate at which the substance partitions out of the gastrointestinal
fluid. As the substances molecular weight of the main constituent of
this UCVCB (C10H11NO4Fe(OH)(H2O)) is higher than 200, MEAHA-Fe is very
unlikely to pass through aqueous pores or be carried through the
epithelial barrier by the bulk passage of water. Administered in an
acute study MEAHA-Fe caused no mortalities up to the limit dose of 2000
mg/kg bw. Therefore, it can be assumed that only limited direct
absorption across the gastrointestinal tract epithelium will occur when
Based on the low vapour pressure of < 0.0015
Pa at 20°C, inhalation exposure is not likely. Only 10 % of the particle
showed a diameter lower than 100 µm and no particles were found less
than 10 µm. Thus, it is very unlikely, that big amounts of the substance
reach the lung. Nevertheless, if the substance reaches the lung, it is
not very likely that the substance is taken up rapidly because of its
physical and chemical parameters (high water solubility and low log
Kow). A structural analogue substance (FeNa-EDDHA) showed no toxicity
after inhalation administration, in an acute inhalation toxicity study
when applied at a dose of 4200 mg/m3. Together, this indicates low
systemic availability after inhalation and if bioavailable, no toxicity
effects via this route of administration.
Similarly, based on physical – chemical
properties of MEAHA-Fe, the substance is not likely to penetrate skin to
a large extent as the very low log Kow value of <–1.5 suggest that a
substance is not likely to be sufficiently lipophilic to cross the
stratum corneum. Very high water solubilities above 10 g/l together with
the log Kow value below 0 further indicate that the substance may be too
hydrophilic to cross the lipid rich environment of the stratum corneum.
Therefore, dermal uptake for these substances will be low. Furthermore,
an in vitro skin irritation study with MEAHA-Fe did not identify
irritation or corrosion effects. An acute dermal toxicity study with a
structural analogue substance (FeNa-EDDHA) did also not observe effects
up to the highest dose tested of 2000 mg/kg bw. In a repeated dose
toxicity study (28 day) with FeNa-EDDHA, beside local effects, only
slight systemic effects on body and adrenal weight were observed at the
limit dose of 1000 mg/kg bw/day, supporting the limited bioavailability
via this route compared with the toxic effects noted after oral
application. No sensitising effects were observed in an in vivo LLNA
study with MEAHA-Fe, again supporting the limited availability of this
substance via dermal exposure.
When reaching the body MEAHA-Fe will be
distributed in body liquids due to its high water solubility (≥50 g/L)
and very low log Kow (<-1.5). Based on this low Kow value MEAHA-Fe is
very unlikely to bioaccumulate in the human body. Based on the structure
of the molecule and its nature, metabolism in the human body will mainly
consist on phase-II metabolising steps, leading to an even better water
solubility for excretion. This is in compliance with the results
obtained in the genotoxic tests showing no differences with and without
metabolising system. Metabolic activation leading to more toxic
metabolites is thus not very likely.
Based on the high water solubility and very
low log Kow, excretion via the urine is likely. As the substance has a
molecular weight of 300 g/mol the excretion of a considerable amount via
the bile is also possible, especially if phase-II conjugation takes
place e.g. with formation of glucoronid derivates.
Based on physical-chemical characteristics,
particularly the high water solubility (≥50 g/L), low octanol-water
partition coefficient (log Kow <-1.5) and low vapour pressure (<0.0015
Pa at 20°C), no or only limited absorption by the dermal and inhalation
routes is expected. For the oral route uptake is more likely compared to
the other routes. Bioaccumulation is not likely to occur based on the
physical-chemical properties. Excretion is expected to occur rapidly via
the urine and the faeces. No sex differences with regard to toxicity are
expected based on data from repeated dose toxicity tests with structural
analogue test substances.
Based on physical-chemical characteristics, particularly the high water
solubility (≥50 g/L), low octanol-water partition coefficient (log Kow
<-1.5) and low vapour pressure (<0.0015 Pa at 20°C), no or only limited
absorption by the dermal and inhalation routes is expected. For the oral
route uptake is more likely compared to the other routes.
Bioaccumulation is not likely to occur based on the physical-chemical
properties. Excretion is expected to occur rapidly via the urine and the
faeces. No sex differences with regard to toxicity are expected based on
data from repeated dose toxicity tests with structural analogue test
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