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EC number: 271-212-0 | CAS number: 68526-55-6
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1973-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because while this study predates GLP guidance, the limited information provided indicates that this study was conducted in a manner similar to OECD 403 guideline.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
Cross-reference
- Reason / purpose for cross-reference:
- read-across: supporting information
Reference
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- read-across based on grouping of substances (category approach)
- Adequacy of study:
- key study
- Study period:
- 1973-06
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: This study is classified as reliable with restrictions because while this study predates GLP guidance, the limited information provided indicates that this study was conducted in a manner similar to OECD 403 guideline.
- Justification for type of information:
- A discussion and report on the read across strategy is given as an attachment in Section 13.
- Reason / purpose for cross-reference:
- read-across source
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- No data reported.
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- A 34 litre chamber was saturated by passing all air flowing into the chamber through a container of the liquid material at a rate of 2.75 litres per minute.
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- > 1 - <= 4 h
- Concentrations:
- Limit test concentration was 87.5 mg/L of 1-octene for 1 hour.
Four hour LC50 test concentrations were 28.0, 31.1, 36.0, 40.5, 48.4, and 53.6 mg/L of 1-octene. - No. of animals per sex per dose:
- Limit test: 10 animals/male/87.5 mg/L
Four hour LC50 test: 10 animals/male/28.0 mg/L; 10 animals/male/31.1 mg/L; 10 animals/male/36.0 mg/L; 10 animals/male/40.5 mg/L; 10 animals/male/48.4 mg/L; and 10 animals/male/53.6 mg/L - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days for surviving animals
- Frequency of observations and weighing: No data reported.
- Necropsy of survivors performed: Yes - Statistics:
- No data reported.
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 8 050 ppm
- 95% CL:
- > 6 600 - <= 9 800
- Exp. duration:
- 4 h
- Remarks on result:
- other: Equivalent to 40,240 mg/m3 (40.2 mg/L)
- Mortality:
- Limit test: 9/10 animals expired at the end of the one hour exposure.
Four hour LC50 test:0/10 animals expired at 28.0 mg/L; 2/10 animals expired at 31.1 mg/L; 5/10 animals expired at 36.0 mg/L; 6/10 animals expired at 40.5 mg/L; 9/10 animals expired at 48.4 mg/L; and 10/10 animals expired at 53.6 mg/L - Clinical signs:
- other: Observations during the four hour LC50 test revealed diaphragmatic breathing, erythema of exposed skin sites, and body tremors.
- Body weight:
- Not data reported.
- Gross pathology:
- Gross necropsy performed on the dead animals in the limit test indicated hemorrhagic lungs, very pale kidneys, and congestive hepatopathy.
Autopsy at the end of the 14-day observation period for the four hour LC50 test indicated that there were no significant pathological changes - Other findings:
- - Other observations: Surviving animals showed immediate recovery once test chemical exposure was ceased and the animals were exposed to fresh air
- Interpretation of results:
- other:
- Remarks:
- Not classified because LC50 is greater than the requirements for a Category 4 vapour toxicant (20 mg/L) Criteria used for interpretation of results: EU
- Conclusions:
- Autopsy at the end of the 14-day observation period indicated that there were no significant pathological changes. Based on these results, that study authors concluded that the LC50 for 1-octene in male Sprague-Dawley rats for a four hour exposure period is 8050 parts per million, with a 95% confidence interval of 6600-9800 parts per million.
- Executive summary:
In an acute inhalation toxicity study, a limit test was first performed on a group of 10 young male adult Sprague-Dawley rats. The animals were exposed to 87.5 mg/L of 1-octene for one hour. After one hour of exposure nine out of ten animals were found dead. Following the limit test a four hour LC50 inhalation toxicity study was performed on 6 groups, 10 per group, of male Sprague-Dawley rats which were exposed to 1octene, whole body, by inhalation route for four hours (vapour atmosphere) at exposure concentrations of 28.0, 31.1, 36.0, 40.5, 48.4, and 53.6 mg/L. Based on the results study authors concluded that the LC50 for 1-octene in male Sprague-Dawley rats for a four hour exposure period is 8050 parts per million, with a 95% confidence interval of 6600-9800 parts per million.
This study was given a Klimisch score of 2 and was classified as reliable with restrictions because while this study predates GLP guidance, the limited information provided indicates that this study was conducted in a manner similar to OECD 403 guideline.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 973
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- not specified
- GLP compliance:
- no
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Reference substance 001
- Cas Number:
- 111-66-0
- Molecular formula:
- C8H16
- Details on test material:
- - Name of test material (as cited in study report): 1-Octene alpha olefin C8
- Substance type: C8 alpha olefin
- Physical state: Liquid
- Other: Density 0.716 g/mL
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- No data reported.
Administration / exposure
- Route of administration:
- inhalation: vapour
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Details on inhalation exposure:
- A 34 litre chamber was saturated by passing all air flowing into the chamber through a container of the liquid material at a rate of 2.75 litres per minute.
- Analytical verification of test atmosphere concentrations:
- not specified
- Duration of exposure:
- > 1 - <= 4 h
- Concentrations:
- Limit test concentration was 87.5 mg/L of 1-octene for 1 hour.
Four hour LC50 test concentrations were 28.0, 31.1, 36.0, 40.5, 48.4, and 53.6 mg/L of 1-octene. - No. of animals per sex per dose:
- Limit test: 10 animals/male/87.5 mg/L
Four hour LC50 test: 10 animals/male/28.0 mg/L; 10 animals/male/31.1 mg/L; 10 animals/male/36.0 mg/L; 10 animals/male/40.5 mg/L; 10 animals/male/48.4 mg/L; and 10 animals/male/53.6 mg/L - Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days for surviving animals
- Frequency of observations and weighing: No data reported.
- Necropsy of survivors performed: Yes - Statistics:
- No data reported.
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- LC50
- Effect level:
- 8 050 ppm
- 95% CL:
- > 6 600 - <= 9 800
- Exp. duration:
- 4 h
- Remarks on result:
- other: Equivalent to 40,240 mg/m3 (40.2 mg/L)
- Mortality:
- Limit test: 9/10 animals expired at the end of the one hour exposure.
Four hour LC50 test:0/10 animals expired at 28.0 mg/L; 2/10 animals expired at 31.1 mg/L; 5/10 animals expired at 36.0 mg/L; 6/10 animals expired at 40.5 mg/L; 9/10 animals expired at 48.4 mg/L; and 10/10 animals expired at 53.6 mg/L - Clinical signs:
- other: Observations during the four hour LC50 test revealed diaphragmatic breathing, erythema of exposed skin sites, and body tremors.
- Body weight:
- Not data reported.
- Gross pathology:
- Gross necropsy performed on the dead animals in the limit test indicated hemorrhagic lungs, very pale kidneys, and congestive hepatopathy.
Autopsy at the end of the 14-day observation period for the four hour LC50 test indicated that there were no significant pathological changes - Other findings:
- - Other observations: Surviving animals showed immediate recovery once test chemical exposure was ceased and the animals were exposed to fresh air
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- Not classified because LC50 is greater than the requirements for a Category 4 vapour toxicant (20 mg/L) Criteria used for interpretation of results: EU
- Conclusions:
- Autopsy at the end of the 14-day observation period indicated that there were no significant pathological changes. Based on these results, that study authors concluded that the LC50 for 1-octene in male Sprague-Dawley rats for a four hour exposure period is 8050 parts per million, with a 95% confidence interval of 6600-9800 parts per million.
- Executive summary:
In an acute inhalation toxicity study, a limit test was first performed on a group of 10 young male adult Sprague-Dawley rats. The animals were exposed to 87.5 mg/L of 1-octene for one hour. After one hour of exposure nine out of ten animals were found dead. Following the limit test a four hour LC50 inhalation toxicity study was performed on 6 groups, 10 per group, of male Sprague-Dawley rats which were exposed to 1octene, whole body, by inhalation route for four hours (vapour atmosphere) at exposure concentrations of 28.0, 31.1, 36.0, 40.5, 48.4, and 53.6 mg/L. Based on the results study authors concluded that the LC50 for 1-octene in male Sprague-Dawley rats for a four hour exposure period is 8050 parts per million, with a 95% confidence interval of 6600-9800 parts per million.
This study was given a Klimisch score of 2 and was classified as reliable with restrictions because while this study predates GLP guidance, the limited information provided indicates that this study was conducted in a manner similar to OECD 403 guideline.
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