Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- acute toxic class method
- Limit test:
- no
Test material
- Reference substance name:
- 2-fluoro-4-methyl-1,3,2-dioxaphospholane
- Cas Number:
- 16415-09-1
- Molecular formula:
- C3H6FO2P
- IUPAC Name:
- 2-fluoro-4-methyl-1,3,2-dioxaphospholane
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- Sex, age, number and body weight range(at receipt): Females, 7 weeks old, 13 rats, 158.36-170.42g
Sex, age, number and body weight range(on administration): Females, 8-9 weeks old, 9 rats, 169.88-226.42g
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Doses:
- Step 1 300 mg/kg bw
Step 2 300 mg/kg bw
Step 3 2,000 mg/kg bw - No. of animals per sex per dose:
- 3
- Control animals:
- no
- Details on study design:
- Quarantine room No.: 2-304
Animal room No. : 2-303
Temperature: 19.0-23.5ºC
Relative humidity: 30.1-69.9%
Air changes: 10-15 times/hour
Lighting: 12 hour light/dark cycle (7 AM to 8 PM via automated timer)
Intensity of illumination: 150-300 Lux
Type and size of a cage: Polycarbonate cage with stainless-steel cage lid, 270Wx50Dx200H (mm)
No. of animal per cage: 1-3 animals/cage
Results and discussion
Effect levels
- Key result
- Sex:
- female
- Dose descriptor:
- LD50
- Effect level:
- > 300 - < 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- All animals survived the duration of the study at 300 mg/kg bw dose level. Three animals at 2,000 mg/kg bw (Step 3) died on Day 0 after dosing.
- Clinical signs:
- other:
- Gross pathology:
- No grossly visible evidence of morphologic abnormalities was evident in any animals at 300 and 2,000 mg/kg bw.
Applicant's summary and conclusion
- Interpretation of results:
- Category 4 based on GHS criteria
- Conclusions:
- Based on the results of the acute oral toxicity study in Sprague-Dawley rats, GHS classification of the test substance, 1,3,2-Dioxaphospholane, 2-fluoro-4-methyl-, was classified to be Category 4.
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