Registration Dossier
Registration Dossier
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EC number: 927-344-2 | CAS number: -
Acute Toxicity: inhalation
Some information in this page has been claimed confidential.
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted using basic scientific principles. Summary is from published literature.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2008
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted using basic scientific principles. Summary is from published literature.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- 8 hour exposure
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no data
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 8 h
- Concentrations:
- 0.27, 0.45, 0.79, 1.9, 2.4, 4.6, 8.2 mg/L; 8.2 mg/L; 8.2 mg/L = 1400ppm
- No. of animals per sex per dose:
- 15 animals
- Control animals:
- yes
- Details on study design:
- Groups of 15 young male rats inhaled various concentrations, to provide a lethal and a no-ill-effect level for single 8-hr periods. Ten of the fifteen animals were randomly selected for the determination of the lethal and the no-ill-effect levels, based upon a 14-day observation period, and five for gross autopsy and histopathological evaluation immediately following the exposure.
- Statistics:
- no data
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 8.2 mg/L air (nominal)
- Remarks on result:
- other: 1400 ppm; 1 animal died at this exposure
- Mortality:
- 1 animal died at the 8.2 mg/L exposure
- Clinical signs:
- other: Their response at this concentration included eye irritation, bloody exudate around the nostrils, and slight loss of coordination. When rats inhaled a measured 4.6 mg/liter (800 ppm), they showed similar signs but no loss of coordination. Inhalation of 2.
- Body weight:
- Weight changes at the 4.6 and 8.2 mg/L doses. No effects at 2.4 mg/L.
- Gross pathology:
- no data
- Other findings:
- none
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- LC50 (4- to 8-h exposures) in rats for mineral spirits is greater than 8.2 mg/L
- Executive summary:
Groups of 15 young male rats inhaled various concentrations, to provide a lethal and a no-ill-effect level for single 8-hr periods. Ten of the fifteen animals were randomly selected for the determination of the lethal and the no-ill-effect levels, based upon a 14-day observation period, and five for gross autopsy and histopathological evaluation immediately following the exposure. The LC50 >8.2 mg/liter (1400 ppm), which was maximum concentration attained under the test system conditions.
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 2 008
- Reference Type:
- publication
- Title:
- Unnamed
- Year:
- 1 975
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- yes
- Remarks:
- 8 hour exposure
- GLP compliance:
- not specified
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- Mineral Spirits
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- no data
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Analytical verification of test atmosphere concentrations:
- no
- Duration of exposure:
- 8 h
- Concentrations:
- 0.27, 0.45, 0.79, 1.9, 2.4, 4.6, 8.2 mg/L; 8.2 mg/L; 8.2 mg/L = 1400ppm
- No. of animals per sex per dose:
- 15 animals
- Control animals:
- yes
- Details on study design:
- Groups of 15 young male rats inhaled various concentrations, to provide a lethal and a no-ill-effect level for single 8-hr periods. Ten of the fifteen animals were randomly selected for the determination of the lethal and the no-ill-effect levels, based upon a 14-day observation period, and five for gross autopsy and histopathological evaluation immediately following the exposure.
- Statistics:
- no data
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- > 8.2 mg/L air (nominal)
- Remarks on result:
- other: 1400 ppm; 1 animal died at this exposure
- Mortality:
- 1 animal died at the 8.2 mg/L exposure
- Clinical signs:
- other: Their response at this concentration included eye irritation, bloody exudate around the nostrils, and slight loss of coordination. When rats inhaled a measured 4.6 mg/liter (800 ppm), they showed similar signs but no loss of coordination. Inhalation of 2.
- Body weight:
- Weight changes at the 4.6 and 8.2 mg/L doses. No effects at 2.4 mg/L.
- Gross pathology:
- no data
- Other findings:
- none
Applicant's summary and conclusion
- Interpretation of results:
- other: Not classified
- Remarks:
- Criteria used for interpretation of results: EU
- Conclusions:
- LC50 (4- to 8-h exposures) in rats for mineral spirits is greater than 8.2 mg/L
- Executive summary:
Groups of 15 young male rats inhaled various concentrations, to provide a lethal and a no-ill-effect level for single 8-hr periods. Ten of the fifteen animals were randomly selected for the determination of the lethal and the no-ill-effect levels, based upon a 14-day observation period, and five for gross autopsy and histopathological evaluation immediately following the exposure. The LC50 >8.2 mg/liter (1400 ppm), which was maximum concentration attained under the test system conditions.
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