Registration Dossier
Registration Dossier
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EC number: 618-251-5 | CAS number: 89182-60-5
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- other information
- Study period:
- Feb-Mar 2006
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well reported GLP Guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
Test material
- Reference substance name:
- 1-deoxy-1-formamido-D-glucitol
- EC Number:
- 618-251-5
- Cas Number:
- 89182-60-5
- Molecular formula:
- C7 H15 N O6
- IUPAC Name:
- 1-deoxy-1-formamido-D-glucitol
- Details on test material:
- N-Formylaminosorbit, white solid, batch: BXR2DEX, content: 98.8%
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Remarks:
- dynamic exposure conditions
- Vehicle:
- other: the test article was aerolized as dry powder
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- gravimetric evaluation
- Duration of exposure:
- 4 h
- Concentrations:
- target: 5000 mg/m³
gravimetric concentration: 4575.0 mg/m³ - No. of animals per sex per dose:
- 5
- Control animals:
- yes
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4 575 mg/m³ air
- Exp. duration:
- 4 h
Any other information on results incl. tables
The 4575 mg/m³ aerosol was inhalable; the mass median aerodynamic diameter (MMAD) was 6.51 µm with a geometric standard deviation of 2.30.
No mortalities occurred as well as no clinical signs, no changes in body weight development and no necropsy findings. Exposed male rats revealed a slight but significant decrease of body temperature.
Applicant's summary and conclusion
- Executive summary:
The acute inhalation toxicity of N-Formylaminosorbit was investigated in male and female Wistar rats. The animals were nose-only exposed for 4 h to a maximum attainable mean solid aerosol concentration of 4575.0 mg/m³ (powder) air. The 4575 mg/m³ aerosol was inhalable; the mass median aerodynamic diameter (MMAD) was 6.51 µm with a geometric standard deviation of 2.30.
No mortalities occurred as well as no clinical signs, no changes in body weight development and no necropsy findings. Exposed male rats revealed a slight but significant decrease of body temperature.
Therefore, the LC50 inhalation (aerosol, 4 h) is above 4575 mg/m³ whereas the NO(A)EL is below 4575 mg/m³.
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