(R)-α-phenylethylammonium (-)-(1R, 2S)-(1,2-epoxypropyl)phosphonate monohydrate

Endpoint summary

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.