Registration Dossier
Registration Dossier
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EC number: 217-123-2 | CAS number: 1746-03-8
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- 1992-01-15 to 1992-02-05
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 401 (Acute Oral Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 (Acute Toxicity (Oral))
- Version / remarks:
- 1979
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Vinylphosphonic acid
- EC Number:
- 217-123-2
- EC Name:
- Vinylphosphonic acid
- Cas Number:
- 1746-03-8
- Molecular formula:
- C2H5O3P
- IUPAC Name:
- vinylphosphonic acid
- Test material form:
- other: Liquid: Clear colourless
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: T 16/91
- Expiration date of the lot/batch: July 1992
- Purity test date:1992-05-13
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: in the dark at room temperature
- Stability under test conditions: stable
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: HOECHST AG, Kastengrund
- Weight at study initiation: 176 - 184 g (males); 178-208 g (females)
- Age at study initiation: males appr: 7 weeks, females appr. 8 weeks
- Fasting period before study: 16 hours before application
- Housing: in groups of 5 in macrolon cages
- Diet: ad libitum (Altromin 1324)
- Water: ad libitum (tap water)
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 55 +/- 20
- Photoperiod (hrs dark / hrs light): 12/12
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: 20 % (w/v)
MAXIMUM DOSE VOLUME APPLIED: 10 mL/kg bw
DOSAGE PREPARATION: The test item was diluted in water to a concentration of 20 % (w/v). - 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 and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight, macroscopically examinations - Statistics:
- - Probit analysis according to Lindner and Weber
- method according to Fieller or Sidak
Results and discussion
- Preliminary study:
- No details on preliminary study.
Effect levelsopen allclose all
- Key result
- Sex:
- male
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- no mortality
- Clinical signs:
- Clinical signs were observed in male and female rats. On day of application reduced spontaneous reaction, drafted flanks, tumbling gait, pilorection, respiratory sounds were noticed. All clinical signs were reversible within 4 days.
- Body weight:
- No changes were observed.
- Gross pathology:
- No macroscopically visible changes were found.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LD50 value of the test item was determined to be > 2000 mg/kg bw.
- Executive summary:
The acute oral toxicity of the test item was investigated in a study according to OECD TG 401 and EU Method B.1 with Wistar rats. Five animals of each sex were exposed to the test item by oral gavage at a limit dose of 2000 mg/kg bw. The animals were observed for 14 days. No mortality occured and the observed clinical signs (reduced spontaneous reaction, drafted flanks, tumbling gait, pilorection, respiratory sounds) were reversible within 4 days. The body weight was not affected. No macroscopic changes were noticed at necropsy. Therefore, the LD 50 was determined to be >2000 mg/kg bw.
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