Triethyl phosphonoacetate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

from 3 March 1997 to 30 April 1997

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Remarks:

Study conducted in compliance with international standard guidelines under GLP conditions.

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

1997

Report date:

1997

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

other: 40 CFR 798.1175

Deviations:

no

Test guideline 2

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 401 (Acute Oral Toxicity)

GLP compliance:

yes

Test type:

standard acute method

Limit test:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Triethyl phosphonoacetate

EC Number:

212-757-6

EC Name:

Triethyl phosphonoacetate

Cas Number:

867-13-0

Molecular formula:

C8H17O5P

IUPAC Name:

ethyl 2-(diethoxyphosphoryl)acetate

Test material form:

liquid

Test animals

Species:

rat

Strain:

Wistar

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ace Animals, Boyertown, PA
- Age at study initiation: 3-5 months
- Weight at study initiation: 226-237 g (m) 245-256 g (f)
- Fasting period before study: 16-20 hours
- Housing: 5/sex/cage
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 1 week

ENVIRONMENTAL CONDITIONS
- Temperature (°C): controlled but conditions not specified
- Humidity (%): no data
- Air changes (per hr): not stated
- Photoperiod (hrs dark / hrs light): 12:12

IN-LIFE DATES: from 7 March 1997 to 21 March 1997

Administration / exposure

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
not applicable

MAXIMUM DOSE VOLUME APPLIED: 0.45 mL

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: 14 days
- Frequency of observations: at 1, 2 and 4 hours post-dosing then once daily for clinical signs and twice daily for mortality
- Frequency of weighing: immediately pre-test, weekly, at death or termination
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight

Results and discussion

Effect levels

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

None

Clinical signs:

other: Dyspnea was observed in two females on days 1 and 2 of the observation period.

Gross pathology:

No abnormalities.

Other findings:

None

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The oral LD50 is greater than 2000 mg/kg, with no mortality or significant clinical effects. No classification is required according to the criteria of EU Reg. 1272/2008.

Executive summary:

In a GLP-compliant acute oral study performed similarly to the OECD 401 guideline, Wistar rats (5 animals/sex) were dosed by gavage with a single dose of undiluted Triethyl Phosphonoacetate (purity of 98.4%) at 2000 mg/kg body weight. The rats were observed 1, 2 and 4 hours post-dose then once daily for 14 days for toxicity and pharmacological effects. The animals were observed twice daily for mortality. Body weights were recorded immediately pre-test, weekly, at death and at termination in the survivors. All animals were examined for gross pathology.

All animals survived the 2000 mg/kg bw oral dose. Dyspnea was observed in two females on days 1 and 2 of the observation period. Body weight changes and necropsy results were normal. It was concluded that the LD50 is greater than 2000 mg/kg bw.

 

Therefore under the test conditions, Triethyl Phosphonoacetate is not classified for acute oral toxicity according to the criteria of the Regulation (EC) 1272/2008 (CLP).

 

This study is considered as acceptable and satisfies the requirement for the acute oral toxicity endpoint.