Alkenes, C11-12

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:

1973

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

Test material information

Constituent 1

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

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.