Registration Dossier
Registration Dossier
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EC number: 418-570-8 | CAS number: 25383-07-7
Endpoint summary
Administrative data
Link to relevant study record(s)
Description of key information
Key value for chemical safety assessment
Additional information
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 toxicokinetics.
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 fosfomycin.
No considerations can be made for the modalities of excretion.
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