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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

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
Qualifier:
according to guideline
Guideline:
EU Method B.1 (Acute Toxicity (Oral))
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes
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
Value:
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
Qualifier:
according to guideline
Guideline:
EU Method B.3 (Acute Toxicity (Dermal))
GLP compliance:
yes
Limit test:
yes
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
Value:
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.