Registration Dossier

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
Cross-reference
Reason / purpose:
reference to same study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1997
Report Date:
1997

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
other: 40 CFR 798.1175
Deviations:
no
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 401 (Acute Oral Toxicity)
GLP compliance:
yes
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: liquid
Details on test material:
Name in study report: Triethyl Phosphonoacetate (CAS #867-13-0)

Test animals

Species:
rat
Strain:
Wistar
Sex:
male/female
Details on test animals 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:
Dyspnea was observed in two females on days 1 and 2 of the observation period.
Body weight:
No effect
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 or the Directive 67/548/EEC.
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) and the Directive 67/548/EEC.

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