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

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

27 Mar - 12 Apr 2001

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 402 (Acute Dermal Toxicity)

Version / remarks:

(adopted 1987)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity: Fixed Dose Procedure)

Version / remarks:

2017

Deviations:

no

Test guideline 3

Qualifier:

according to guideline

Guideline:

EU Method B.3 (Acute Toxicity (Dermal))

Version / remarks:

(adopted 1992)

Deviations:

no

Test guideline 4

Qualifier:

according to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Version / remarks:

(adopted in August 1998)

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 animals

Species:

rat

Strain:

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

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: 9 weeks
- Weight at study initiation: 348 - 369 g (males), 210 - 219 g (females)
- Housing: individually in suspended stainless steel, wire mesh cages
- Diet: certified Rodent Pellet diet "A04C (Usine d'Alimentation Rationnelle, Villemoisson-sur-Orge, France), ad libitum
- Water: filtered and softened water from the municipal water supply, ad libitum
- Acclimation period: 13 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: 14 Mar To 10 - 12 Apr 2001

Administration / exposure

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: clipped skin from the dorsum and flanks
- % coverage: 10%
- Type of wrap if used: The test material was held in contact with the skin with a 8-ply gauze dressing backed with an elastic wrap and a plastic tape. Removal and ingestion of the test article was prevented by placing an elastic wrap over the trunk and the test area.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): residual test material was removed with water
- Time after start of exposure: 24 h

TEST MATERIAL
- Concentration (if solution): 22.1% (aqueous solution)
- Constant volume or concentration used: yes (individual volumes were calculated according to the animals´weight on the day of dosing).

Duration of exposure:

24 h

Doses:

2000 mg/kg bw

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 at least 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:

Mean values were calculated for the body weight 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.

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 was observed. The test substance did not induce any other adverse effects. The LD50 was determined to be greater than 2000 mg/kg bw/day.