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EC number: 418-570-8
CAS number: 25383-07-7
Phenethylammonium salt of fosfomycin is not classified for any
acute toxicity effects according to toxicological data available and
according to Regulation (EC) n. 1272/2008.
The substance is not harmful after oral and dermal acute exposure
and it resulted not irritant to the skin and to the eyes inin vivotest
Moreover, it did not result sensitizing.
According to two in vitro test systems, Phenethylammonium
salt of fosfomycin resulted not genotoxic.
In the 28-day oral repeated-dose toxicity study in rats, a NOAEL
of 150 mg/kg bw/day has been identified (mid-dose tested). At the higher
dose tested (500 mg/kg bw/day), some effects like salivation after
gavage, fur loss, lacrimation and/or eyelid swelling, chromodacryorrhea,
abdomen dilation and poor conditions were observed. Reversibility of the
above-mentioned clinical changes was ascertained.
At the end of the treatment period, a few changes were seen that
were considered related to the test article administration. These were
on the whole slight increases in mean weights of liver and kidneys in
males and females of the intermediate and high dose groups, (usually
being statistically significant), a slight decrease in absolute values
of testes in males and in spleen in females of the high dose group. At
the end of recovery, the only change seen was an evident decrease in
weights of tests in the group previously treated with 500 mg/kg/day,
while other organs affected at the end of the treatment period showed
In the oral one-generation study performed with rats, the NOEL of
50 mg/kg bw/day was observed in parent females and in offspring. The
NOAEL of 100 mg/kg bw/day was, instead, observed in parent females and
As no acute effects are expected for Phenethylammonium salt of
fosfomycin, no acute DNEL were derived as no/low hazard has been
The only local effects after repeated exposure were fur loss and
chromodacryorrhea in female rats during the oral 28-day repeated
toxicity study. Although the relevance of these effects after inhalation
and dermal exposure is unclear, DNELs were derived from a precautionary
and conservative point of view.
Although inhalation exposure is considered to be negligible (see
toxicokinetics summary and CSR Section 9), the DNEL after long-term
inhalation exposure has been derived from a precautionary and
conservative point of view.
Long-term systemic DNELs have been derived starting from the NOEL
of the one-generation study with rats.
Details of the derivations are reported above.
Phenethylammonium salt of fosfomycin is an intermediate intended only to
industrial use. No exposure is foreseen for consumers and humans via
environment (see CSR Section 9).
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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