Phosphonic acid, monoethyl ester, sodium salt (1:1)

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

31 Oct - 14 Nov 2000

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2001

Report date:

2001

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

Version / remarks:

(adopted 1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU Method B.1 (Acute Toxicity (Oral))

Version / remarks:

(adopted 1992)

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Remarks:

Republique Francaise, Premier Ministre, Groupe Interministeriel Des Produits Chimiques, Paris Cedex, France

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

-

EC Number:

444-960-2

EC Name:

-

Cas Number:

39148-16-8

Molecular formula:

C2H6O3P.Na

IUPAC Name:

sodium ethyl phosphonate

Test material form:

liquid

Test animals

Species:

rat

Strain:

other: Wistar (AF) rats RJ:WI (IOPS AF)

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: R. Janvier, Le Genest St Isle, France
- Age at study initiation: 8 weeks
- Weight at study initiation: 261 - 281 g (males), 174 - 191 g (females)
- Fasting period before study: animals were fasted overnight until 3 - 4 hours after dosing
- Housing: individually in suspended stainless steel, wire mesh cages
- Diet: certified Rodent Pellet diet "M 20 controle" (Pietrement, Provins, France), ad libitum
- Water: filtered and softened water from the municipal water supply, ad libitum
- Acclimation period: 6 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 40 - 70
- Air changes (per hr): 10 - 15 (average, not monitored)
- Photoperiod (hrs dark / hrs light): (12 / 12)

IN-LIFE DATES: From: 31 Oct To 14 Nov 2000

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

DOSE VOLUME APPLIED: 8.3 mL/kg bw

Doses:

2000 mg/kg bw (adjusted to purity)

No. of animals per sex per dose:

5

Control animals:

no

Details on study design:

- Duration of observation period following administration: 15 days
- Frequency of observations and weighing: animals were observed 1 h after substance administration, at least once more on the Day of dosing and daily thereafter and individual body weights were determined periodically on Day -1 (prior to substance administration), 1, 8 and 15.
- Necropsy of survivors performed: yes
- Other examinations performed: other: macroscopical examination of abdominal and thoracic cavities, major tisues and organs

Statistics:

For body weights, means and standard deviations were calculated for each sex.

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Remarks on result:

other: adjusted to purity

Mortality:

No mortality occurred during the study period.

Clinical signs:

other: other: No clinical signs of toxicity were observed up to the end of the observation period.

Gross pathology:

Macroscopical examinations revealed no substance-related findings.

Applicant's summary and conclusion

Interpretation of results:

other: CLP/EU GHS criteria not met, no classification required according to Regulation (EC) No 1272/2008

Conclusions:

Under the conditions chosen, no mortality occurred during the study period. The test substance did not induce any other adverse effects. The LD50 was concluded to be greater than 2000 mg/kg bw/day.