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Registration Dossier
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EC number: 201-604-9 | CAS number: 85-42-7
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP compliant study. Some details on methods / results not available
Data source
Reference
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 981
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- 4 hours exposure to maximum aerosol concentration achievable
- GLP compliance:
- yes
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Cyclohexane-1,2-dicarboxylic anhydride
- EC Number:
- 201-604-9
- EC Name:
- Cyclohexane-1,2-dicarboxylic anhydride
- Cas Number:
- 85-42-7
- Molecular formula:
- C8H10O3
- IUPAC Name:
- octahydro-2-benzofuran-1,3-dione
- Test material form:
- gas: vapour
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- not specified
- Details on inhalation exposure:
- VEHICLE
- Composition of vehicle (if applicable): Ethanol
- Concentration of test material in vehicle (if applicable): 80%
- Justification of choice of vehicle: Substance stable in selected vehicle
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: 75% of the particles were less than 10 μm indicating a respirable aerosol.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): 5.8 μm (GSD = 2.2). - Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- 4 h
- Concentrations:
- 1100 mg/m3
- No. of animals per sex per dose:
- 5 male / 5 female
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observations - Daily; Body weights - Days 3, 4, 5, 8 and 15
- Necropsy of survivors performed: yes
Results and discussion
Effect levelsopen allclose all
- Sex:
- male/female
- Dose descriptor:
- LC0
- Effect level:
- 1 100 mg/m³ air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 1 100 mg/m³ air (nominal)
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- None
- Clinical signs:
- other: Decreased activity noted during exposure.
- Body weight:
- Depressed during the first week, followed by recovery during second week.
- Gross pathology:
- Not remarkable
Applicant's summary and conclusion
- Conclusions:
- Acute inhalation toxicity following 4 hours exposure to the highest achievable aerosol concentration has been investigated in the rat. The LC50 was in excess of 1100 mg/m³.
- Executive summary:
Acute inhalation toxicity following 4 hours exposure to the highest achievable aerosol concentration has been investigated in the rat. The LC50 was in excess of 1100 mg/m³.
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