Registration Dossier
Registration Dossier
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EC number: 619-646-5 | CAS number: 1067-87-4
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 16 Dec 2014 to 22 Jan 2015
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline study under GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 015
- Report date:
- 2015
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 bis (Acute Oral Toxicity - Fixed Dose Procedure)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- fixed dose procedure
- Limit test:
- no
Test material
- Reference substance name:
- Diethyl allylphosphonate
- EC Number:
- 619-646-5
- Cas Number:
- 1067-87-4
- Molecular formula:
- C7H15O3P
- IUPAC Name:
- Diethyl allylphosphonate
- Test material form:
- other: liquid
- Details on test material:
- Identification: Diethyl Allylphosphonate
Appearance/Physical State: Clear colorless liquid
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Laboratories Ltd., Oxon, UK
- Age at study initiation: 8-12 weeks
- Weight at study initiation: 147-163 g
- Fasting period before study: yes, overnight and upto 3-4 hours post-dosing
- Housing: 4/solid floor polypropylene cage
- Diet: 2014CTeklad Global Rodent diet ad libitum
- Water: tap water ad libitum
- Acclimation period: ≥ 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-25 °C
- Humidity (%): 30-70%
- Air changes (per hr): 15/hour
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- other: 2000 mg/kg bw as such, 300 mg/kg bw in distilled water
- Details on oral exposure:
- VEHICLE: distilled water (only at 300 mg/kg bw)
MAXIMUM DOSE VOLUME APPLIED: 10 mL at 300 mg/kg bw, 1.95 mL at 2000 mg/kg bw - Doses:
- sighting study: 300 and 2000 mg/kg bw
main study: 300 mg/kg bw - No. of animals per sex per dose:
- sighting study: 1 female/dose
main study: 4 females - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Body weight: at study start and weekly thereafter
- Clinical signs: ½, 1, 2, and 4 hours after dosing and then daily for 14 days
- Mortality/morbidity: twice daily
- Necropsy : macroscopic examination - Statistics:
- NA
Results and discussion
- Preliminary study:
- In the sighting study 1 female was treated at 300 mg/kg bw. No mortality or clear toxicity was observed. Therefore 1 female was dosed at 2000 mg/kg bw. This female was terminated for humane reasons within 30 minutes after dosing. The main test was therefore performed with 4 females dosed at 300 mg/kg bw.
Effect levels
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Mortality:
- In the sighting study the female at 2000 mg/kg bw was terminated within 30 min after dosing
No mortality at 300 mg/kg bw - Clinical signs:
- other: 2000 mg/kg bw: labored and noisy respiration, prostration, hypothemia and vocalisation 300 mg/kg bw: ataxia and hunched posture in all females 2-4 hours after dosing
- Gross pathology:
- 2000 mg/kg bw: haemorraghic gastric mucosa, gaseous content and haemorraghic non-glandular epithelium of the stomach
300 mg/kg bw: no abnormalities
Applicant's summary and conclusion
- Interpretation of results:
- harmful
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The LD50 of the substance is between 300 and 2000 mg/kg bw
- Executive summary:
In an acute oral study according to the fixed dose method, a single female rat dosed with the substance at 2000 mg/kg bw by gavage was terminated for humane reasons within 30 minutes after dosing. 5 females dosed with the substance at 300 mg/kg bw did not exhibit mortality, significant clinical signs, effect on body weight or gross pathology. Therefore the LD50 of the substance is between 300 and 2000 mg/kg bw
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