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Toxicological information

Acute Toxicity: inhalation

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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:
read-across: supporting information

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
1973

Materials and methods

Test guideline
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 403 (Acute Inhalation Toxicity)
Deviations:
not specified
GLP compliance:
no
Test type:
standard acute method
Limit test:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
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

Test animals

Species:
rat
Strain:
Sprague-Dawley
Sex:
male
Details on test animals 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:
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.