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EC number: 212-757-6 | CAS number: 867-13-0
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:
- 1 997
- Report date:
- 1997
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- other: 40 CFR 798.1175
- Deviations:
- no
- 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
- 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
Constituent 1
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.
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