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EC number: 243-175-0 | CAS number: 19592-55-3
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2013-06-24 to 2013-06-27
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: In accordancw with OECD and GLP
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
- Report date:
- 2013
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.1300 (Acute inhalation toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- other: Method Development
Test material
- Reference substance name:
- 3,20-bis(ethylenedioxy)pregna-5,7-diene
- EC Number:
- 243-175-0
- EC Name:
- 3,20-bis(ethylenedioxy)pregna-5,7-diene
- Cas Number:
- 19592-55-3
- Molecular formula:
- C25H36O4
- IUPAC Name:
- (1S,3aR,9aR,9bS,11aS)-9a,11a-dimethyl-1-(2-methyl-1,3-dioxolan-2-yl)-1,2,3,3a,6,8,9,9a,9b,10,11,11a-dodecahydrospiro[cyclopenta[a]phenanthrene-7,2'-[1,3]dioxolane]
- Test material form:
- solid: crystalline
- Details on test material:
- - Name of test material (as cited in study report): Proketal; pregna-5,7-diene-3,20-dione, cyclic 3,20-bis(1,2-ethanediyl acetal)
- Molecular formula (if other than submission substance): C25H36O4
- Molecular weight (if other than submission substance): 400.5
Stability under test conditions: Stable
- Storage condition of test material: At room temperature in the deark
Constituent 1
Test animals
- Species:
- other: it is technically not possible to generate a suitable test atmosphere in order to determine the inhalation toxicity of Proketal
- Strain:
- not specified
- Sex:
- not specified
- Details on test animals or test system and environmental conditions:
- Based on the trial generation results and laboratories experience, it was concluded that because of the
intrinsic properties of Proketal it is technically not possible to generate a suitable test atmosphere in
order to determine the inhalation toxicity of Proketal.
Administration / exposure
- Route of administration:
- inhalation: dust
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Details on inhalation exposure:
- Based on the trial generation results and laboratories experience, it was concluded that because of the
intrinsic properties of Proketal it is technically not possible to generate a suitable test atmosphere in
order to determine the inhalation toxicity of Proketal. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks on duration:
- Not possible
- Concentrations:
- 0.2mg/L to 4.8mg/L
- No. of animals per sex per dose:
- None
- Control animals:
- not specified
- Details on study design:
- Based on the trial generation results and laboratories experience, it was concluded that because of the
intrinsic properties of Proketal it is technically not possible to generate a suitable test atmosphere in
order to determine the inhalation toxicity of Proketal. - Statistics:
- None
Results and discussion
Effect levels
- Remarks on result:
- not determinable
- Remarks:
- it is technically not possible to generate a suitable test atmosphere in order to determine the inhalation toxicity of Proketal
- Mortality:
- N/A
- Clinical signs:
- other: N/A
- Body weight:
- N/A
- Gross pathology:
- N/A
- Other findings:
- N/A
Any other information on results incl. tables
Based on the trial generation results and laboratories experience, it was concluded that because of the intrinsic properties of Proketal it is technically not possible to generate a suitable test atmosphere in order to determine the inhalation toxicity of Proketal.
Applicant's summary and conclusion
- Interpretation of results:
- other: Inconclusive
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- Determination of Acute Toxicity : Inhalation not possible due to substance intrinsic properties.
- Executive summary:
Based on the trial generation results and laboratories experience, it was concluded that because of the intrinsic properties of Proketal it is technically not possible to generate a suitable test atmosphere in order to determine the inhalation toxicity of Proketal.
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