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Description of key information

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records
Reference
Endpoint:
acute toxicity: oral
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry, permission to refer granted by ECHA
Reference:
Composition 0
Qualifier:
according to
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Route of administration:
oral: unspecified
Vehicle:
other: Methocel 0.5%
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels:
The main clinical signs observed were: hypoactivity,
muscular tremors, salivation, palpebral closure,
hypothermia, shallow breathing, piloerection and hunched
posture starting from 30 minutes - 4 hours and lasting up to
6-24 hours after the test article administration.
Sporadic cases of ataxia, reddish nasal discharge,
chromodacryorrhea were also observed.
Recovery of all treated rats was achieved within 24
(females) - 48 hours (males) of treatment.
Low body weight gain was observed in some animals only at
the day 3 weighing. Body weight gain returned to normal at
the subsequent weighing.
Gross pathology:
Effects on organs:
Terminal autopsy findings were normal.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Acute toxicity: via inhalation route

Endpoint conclusion
Endpoint conclusion:
no study available

Acute toxicity: via dermal route

Link to relevant study records
Reference
Endpoint:
acute toxicity: dermal
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Information from migrated NONS file, as per inquiry, permission to refer granted by ECHA
Reference:
Composition 0
Qualifier:
according to
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Limit test:
yes
Test material information:
Composition 1
Species:
rat
Strain:
Sprague-Dawley
Sex:
male/female
Type of coverage:
semiocclusive
Duration of exposure:
24 h
Sex:
male/female
Dose descriptor:
LD50
Effect level:
> 2 000 mg/kg bw
Mortality:
Male: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Female: 2000 mg/kg bw; Number of animals: 5; Number of deaths: 0
Clinical signs:
Signs of toxicity related to dose levels: None
Gross pathology:
Effects on organs:
No changes were observed in the animals killed at the end of the study.
Other findings:
Signs of toxicity (local):
Slight erythema was observed at the application site during the first days of the study in two male and one female rats.
Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed
Dose descriptor:
LD50
2 000 mg/kg bw

Additional information

An acute oral toxicity study and an acute dermal toxicity study are available for Phenethylammonium salt of fosfomycin. In both studies, the LD50 resulted > 2000 mg/kg bw.

Justification for classification or non-classification

According to Regulation (EC) n. 1272/2008, Phenethylammonium salt of fosfomycin is not classified for acute toxicity by oral and dermal routes.