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EC number: 418-570-8
CAS number: 25383-07-7
No experimental studies regarding toxicokinetics of
Phenethylammonium salt of fosfomycin are available. Nevertheless
available data and information derived from the testing strategy adopted
for the chemical permit to evaluate main aspects of the substance
Phenethylammonium salt of fosfomycin is expected to be absorbed by
oral as, in the acute and repeated-dose toxicity studies by this route,
systemic effects have been observed.
According to the granulometry study, the particles of this
substance, which is a crystalline powder, have a D10 > 20 µm and
therefore the powder of this substance is not expected to be inhaled.
Moreover, the vapour pressure of the substance at 30°C is < 0.0028 Pa
and therefore it is considered negligible (water vapour pressure at
30°C: ~ 4232 Pa>). In view of these properties and the OCs/RMMs adopted
at the site of use the exposure via inhalation route is expected to be
negligible and absorption data regarding this route of exposure are
considered not to be relevant.
Neither systemic nor local effects were observed in the dermal
acute toxicity studies at the dose of 3,000 mg/kg bw. Results of these
studies may lead to the conclusion that the chemical is expected to have
a low skin absorption.
Systemic effects observed in toxicity studies permit to make
considerations on the distribution of Phenethylammonium salt of
fosfomycin, because effects related to the oral exposure to the
substance were observed in liver, kidney and testis. Moreover
biochemical changes have been observed.
Considering the low experimental logPOW for the substance, a low
bioaccumulation potential can be expected for Phenethylammonium salt of
No considerations can be made for the modalities of excretion.
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