Oct-2-ene

Endpoint summary

Description of key information

Not acutely hazardous after ingestion, inhalation or skin contact, based on animal test data.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

Reference 1

Endpoint:

acute toxicity: oral

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: see 'Remark'

Remarks:

This study is classified as reliable with restrictions because while there is no statement regarding whether this study was conducted according to GLP guidance or equivalent. However, the limited information provided indicates that this study was conducted in a manner similar to OECD 420 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: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

not specified

GLP compliance:

no

Test type:

fixed dose procedure

Specific details on test material used for the study:

- Name of test material (as cited in study report): 1-Octene alpha olefin C8
- Physical state: Liquid
- Other: Density 0.716 g/mL

Species:

rat

Strain:

Sprague-Dawley

Sex:

male

Details on test animals or test system and environmental conditions:

No data reported.

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

VEHICLE
- Concentration in vehicle: Undiluted

Doses:

10,000 mg/kg undiluted

No. of animals per sex per dose:

10 male rats

Control animals:

no

Details on study design:

- Duration of observation period following administration: 14 days
- Necropsy of survivors performed: Yes

Statistics:

No data reported.

Preliminary study:

Oral LD50> 10,000 mg/kg

Sex:

male

Dose descriptor:

LD50

Effect level:

> 10 000 mg/kg bw

Mortality:

All animals survived.

Clinical signs:

other: All animals survived without any signs toxicity.

Gross pathology:

Autopsy revealed no visible pathological changes.

Other findings:

No data reported.

Interpretation of results:

study cannot be used for classification

Remarks:

Not classified because LD50 is greater than the requirements for a Category 4 toxicant (2000 mg/kg)

Conclusions:

The study reported LD50 to be greater than 10,000 mg/kg.

Executive summary:

In an acute oral toxicity study, 10 fasted, male Sprague-Dawley rats were given a single oral dose of undiluted 1-octene at a dose of 10,000 mg/kg and observed for 14 days. There were no treatment related clinical signs, necropsy findings or changes in body weight reported in the study. The oral LD50 was determined to be greater than 10,000 mg/kg in males.

This study received a Klimisch score of 2 and is classified as reliable with restrictions because there is no statement regarding whether this study was conducted according to GLP guidance or equivalent. However, the limited information provided indicates that this study was conducted in a manner similar to OECD 401 guideline.

Reference 2

Endpoint:

acute toxicity: oral

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-03-25 to 1982-04-08

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restriction because the study was carried out according to or closely followed OECD 420 guideline and was GLP compliant.

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: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 420 (Acute Oral Toxicity - Fixed Dose Method)

Deviations:

yes

Remarks:

Minor deviations related to environmental conditions were reported

GLP compliance:

yes

Test type:

fixed dose procedure

Specific details on test material used for the study:

- Name of test material (as cited in study report): Neodene 8 Alpha Olefin
- Substance type: C8 alpha olefin
- Physical state: Liquid
- Other: Clear liquid

Species:

rat

Strain:

Fischer 344

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Charles River Breeding Laboratory (Portage, Maine)
- Age at study initiation: Not reported
- Weight at study initiation: Male - 195.5 grams (average of test and control animals); Female - 150 grams (average of test and control animals)
- Fasting period before study: Overnight prior to dosing
- Housing: Acclimation - Individual wire mesh cages; Test - Bioclean unit TX-606
- Diet (e.g. ad libitum): Ad libitum
- Water (e.g. ad libitum): Ad libitum
- Acclimation period: 14 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20.0°C to 21.7°C
- Humidity (%): 31 to 54%
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12 hrs dark/12 hrs light

IN-LIFE DATES: From: 1982-03-10 To: 1982-04-08

Route of administration:

oral: gavage

Vehicle:

unchanged (no vehicle)

Details on oral exposure:

MAXIMUM DOSE VOLUME APPLIED: 5 mL/kg

Doses:

Single dose of 5.0 mL/kg

No. of animals per sex per dose:

5/sex/dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Clinical observations - Hourly for the first 6 hours, at 24 hours, and twice daily subsequently till day 14; Body weight - days 0, 7, and 14
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs and body weight

Statistics:

Statistical analysis of body weights included calculation of the mean (F) and standard error (S.E.). Determination of the significance of body weight changes on days 7 and 14 compared to controls was made using an independent T-test. The lethal dose (LD50 and 95% confidence limits) was not calculated but was found to be greater than 5.0 ml/kg body weight.

Preliminary study:

No lethality was observed in male and female rats (1/sex/dose) exposed orally to Neodene 8 Alpha Olefin at 1.0, 2.5, or 5.0 mL/kg.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 5 mL/kg bw

Mortality:

No mortality was observed in either male or female rats dosed at 5.0 mL/kg.

Clinical signs:

other: Hunched posture, unsteady stance, tip-toe gait, and hypoactivity were some signs of clinical toxicity that were observed in male and female rats 1 hour post dosing. However, test animals were seen to recover from these effects 1 to 4 days post exposure. S

Gross pathology:

No remarkable treatment related findings were observed in either male or female rats.

Interpretation of results:

other:

Remarks:

Acute oral LD50 > 5.0 mL/kg Criteria used for interpretation of results: EU

Conclusions:

Acute oral LD50 > 5.0 mL/kg.

Executive summary:

In an acute oral toxicity study, groups of fasted, male and female Fischer 344 rats (5/sex) were given a single oral dose of Neodene 8 Alpha Olefin (undiluted) at a single dose of 5.0 mL/kg via oral intubation. The animals were subsequently observed for 14 days. 

 

There was no mortality observed in either male or female rats treated orally with Neodene 8 Alpha Olefin. There were no treatment related clinical signs, necropsy findings or changes in body weight observed through the 14 days study period. Based on the lack of significant treatment-related signs of clinical toxicity, the acute oral LD50 was determined to > 5.0 mL/kg in males and females.

 

This study received a Klimisch score of 1 and is classified as reliable without restriction because the study was carried out according to or closely followed OECD 420 guideline and was GLP compliant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Acute toxicity: via dermal route

Link to relevant study records

Reference

Endpoint:

acute toxicity: dermal

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1982-03-02 to 1982-04-06

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: This study is classified as reliable without restrictions because the study closely followed OECD 402 guidelines and was GLP compliant.

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: supporting information

Qualifier:

equivalent or similar to guideline

Guideline:

OECD Guideline 402 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Study conducted before guideline introduced

Qualifier:

equivalent or similar to guideline

Guideline:

EPA OPPTS 870.1200 (Acute Dermal Toxicity)

Deviations:

yes

Remarks:

Study conducted before guideline introduced

GLP compliance:

yes

Test type:

fixed dose procedure

Limit test:

yes

Species:

rabbit

Strain:

New Zealand White

Sex:

male/female

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Ray Nichols Rabbitry, Lumberton, Texas
- Weight at study initiation: Approximately 3000 grams
- Acclimation period: 21 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.4-21.1°C
- Humidity (%): 25-60%
- Photoperiod (hrs dark / hrs light): 12 hours dark/12 hours light

IN-LIFE DATES: From: 1982-03-02 To: 1982-04-06

Type of coverage:

occlusive

Vehicle:

unchanged (no vehicle)

Details on dermal exposure:

TEST SITE
- Area of exposure: 4 x 4 inch
Type of wrap if used: aluminium foil taped in place then overwrapped with an elastic Ace bandage

REMOVAL OF TEST SUBSTANCE
- Washing (if done): With a moist towel
- Time after start of exposure: 24 hours

TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2 mL/kg
- Constant volume or concentration used: Yes

Duration of exposure:

24 hours

Doses:

2 mL/kg

No. of animals per sex per dose:

Eight animals/sex/dose

Control animals:

yes

Details on study design:

- Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Animals were observed at 1, 2, 4, 6, and 24 hours after exposure, then twice daily for 14 days. Animals were weighed at study initiation, 7 days, and 14 days.
- Necropsy of survivors performed: Yes
- Other examinations performed: Clinical signs, body weight, and skin irritation

Statistics:

An independent T-test with p<0.05 was used on body weight data.

Preliminary study:

None performed.

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 mL/kg bw

Remarks on result:

other: Equivalent to > 1430 mg/kg

Mortality:

No animals died over the 14 day observation period.

Clinical signs:

other: There were no clinical signs of toxicity related to treatment.

Gross pathology:

The only findings at necropsy were related to the treatment site and included white crust material on the skin and fur (considered dried test material), alopecia, abrasions, erosion, and in one animal cutaneous firmness.

Other findings:

- Other observations: There was mild to moderate erythema and oedema following the removal of the wrappings at 24 hours. Mild irritation was still present at 14 days. There was no difference in the level of irritation between the intact and abraded skin.

 

Summary of Skin Irritation (Average and Range)
	24 hours		14 days
	erythema	oedema	erythema	oedema
Treated intact skin	1.6 (0 to 2)	1.4 (0 to 3)	0.9 (0 to 2)	0.4 (0 to 1)
Control intact skin	0.1 (0 to 1)	0.0	0.0	0.0
Treated abraded skin	0.8 (0 to 2)	1.4 (1 to 4)	1.3 (0 to 2)	0.5 (0 to 1)
Control abraded skin	0.0	0.4 (0 to 1)	0.0	0.0

 

 

Interpretation of results:

other: Not classified

Remarks:

LD50 is greater than the maximum concentration tested (i.e., 1430 mg/kg) Criteria used for interpretation of results: EU

Conclusions:

Acute dermal LD50 was > 2.0 mL/kg.

Executive summary:

In an acute dermal toxicity study, groups of New Zealand rabbits (8/sex) were dermally exposed to 2 mL/kg of undiluted Neodene 8 alpha olefin (i.e., 1 -octene) to a 4 x 4 inch section for 24 hours. Four of the animals per sex and treatment had their skin abraded prior to treatment. Animals were then observed for 14 days. There was no treatment-related lethality, clinical signs of toxicity, changes in body weight, or necropsy findings. The only notable finding was mild to moderate skin irritation following the removal of the wrappings at 24 hours. Mild skin irritation was still present on day 14. Skin irritation was not effected by abrading the skin. The dermal LD50 was determined to be greater than 2.0 mL/kg in males and females. This study received a Klimisch score of reliable without restrictions because the study closely followed OECD 402 guidelines and was GLP compliant.

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Additional information

Information is available on the acute toxicity of the following members of this category:

 

Test substance identity	Route
	Oral	Inhalation	Dermal
Hex-1-ene	√	√	√
Alkenes, C6-8-branched, C7-rich		√	√
Alkenes, C7-9-branched, C8-rich		√
Alkenes, C8-10-branched, C9-rich		√
Oct-1-ene	√	√	√
Alkenes C10/C11/C12/C13 (aka Alkenes C11-12)		√
Alkenes C11-15 (aka tetradecene)	√		√
Alkenes, C12-14 α-	√		√
Hexadec-1-ene (MC)	√
Hexadecene	√		√
Octadecene	√		√
Hydrocarbons, C14-30, olefin-rich	√		√
Alkenes, C20-24 α-	√
Alkenes, C20-24 (aka C20 -C22 (even numbered, linear and branched) and C24(branched) alkenes)	√		√
Alkenes, C24-28 α-	√
Alkenes, C24-28 (aka Alkenes, C21-32 linear and branched)	√

 

Details of these studies are summarised below.

Acute oral toxicity

In an acute oral toxicity study, groups of fasted Fisher 344 rats (5 male, 5 female) were given a single oral dose via gavage of hex-1-ene (Neodene 6) at doses of 0, 1000, 1800, 3200, or 5600 mg/kg bw and observed for 14 days (Albert et al., 1983). Controls received deionised water. No deaths occurred during this study and body weight was not affected by treatment. Clinical signs of toxicity included mucoid diarrhoea over the first day in treated rats. The only remarkable change observed during necropsy was bilateral luminal dilation with clear fluid in the uterus of some treated females rats. This change, which was not observed in control animals, occurred in 4/5 of 1000 mg/kg treated females, 1/5 of 3200 mg/kg treated females, and 4/5 of 5600 mg/kg treated females. The pathologist noted that this was a common occurrence for the laboratory, and it was not considered treatment-related. The acute oral LD50 for Neodene 6 alpha olefin in male and female rats was reported as >5600 mg/kg. The results of this study indicate that hex-1-ene is not acutely toxic via the oral exposure route.

The acute oral toxicity of octadec-1-ene has been investigated in two studies. In the first investigation, groups of fasted, male and female Fischer 344 rats (5/sex) were given a single oral dose of undiluted Neodene 8 Alpha Olefin (oct-1-ene) at 5.0 mL/kg via oral intubation (Wilborn, 1983). There was no mortality observed in either sex, and no treatment-related clinical signs, necropsy findings or changes in body weight observed through the 14 day observation period. Based on a lack of significant treatment-related findings, the acute oral LD50 was determined to > 5.0 mL/kg (equivalent to 3575 mg/kg bw using a density of 0.7149 mg/cm3 for oct-1 -ene) in male and female rats. In the second key study, 10 fasted, male Sprague-Dawley rats received a single oral dose of undiluted oct-1-ene at 10,000 mg/kg after which the animals were observed for 14 days (Monrose, 1973). There were no treatment-related clinical signs, necropsy findings or changes in body weight reported. The oral LD50 was determined to be > 10,000 mg/kg. These results indicate that oct-1 -ene is not acutely toxic by the oral exposure route.

In an acute oral toxicity study on octadecene, five male and female young adult Sprague-Dawley rats were administered 5050 mg/kg (5.88 mL/kg) of test substance via oral intubation. Body weight gain was unaffected as a result of treatment, however diarrhoea, piloerection, and polyuria were present in treated animals. Gross necropsy at study termination revealed no observable abnormalities. None of the treated animals died during the course of the study. Based on these results, the acute oral LD50 for octadecene in Sprague Dawley rats is > 5050 mg/kg (5.88 mL/kg). The results of this study indicate that octadecene is not acutely toxic by the oral exposure route.

Acute inhalation toxicity

In a study reported by Rinehart (1967), rats were exposed to hex-1-ene vapour for 4 hours. The study was well conducted and reported, although high exposure concentrations were used (above the 20 mg/L limit for vapours required for classification and labelling; EU CLP). No mortality was reported in the lowest dose group (95 mg/L) although mild signs of anaesthesia were noted among treated animals.

In an acute inhalation study on oct-1-ene, 9 out of 10 young male adult Sprague-Dawley rats died during exposure to 87.5 mg/L test substance for 1 hour (Monrose, 1973). Subsequently, 6 groups of male Sprague-Dawley rats (10/group) were exposed (whole body) to vapour concentrations of 6113, 6833, 7860, 8842, 10,567, and 11,702 parts per million (equivalent to 28.0, 31.1, 36.0, 40.5, 48.4, and 53.6 mg/L) for 4-hours. The LC50 was reported as 8050 parts per million (37 mg/L), with a 95% confidence interval of 6600-9800 parts per million.

Acute dermal toxicity

The acute dermal toxicity of hex-1-ene (Neodene 6) was investigated in groups of New Zealand White rabbits (4 males, 4 females) exposed to undiluted test substance at a dose of 2000 mg/kg bw (Albert et al., 1983). The test substance was applied to abraded skin under occlusion. All animals survived until the end of the study (14-days post treatment). There were no clinical signs of toxicity or effects on body weight. The skin was the only area affected, with minimal irritation noted after the 24 -hour exposure period. This had resolved by day 14, however white crusty material on the skin and fur, alopecia, and abrasions and focal reddened areas were noted at necropsy in treated animals. The acute dermal LD50 for undiluted Neodene 6 alpha olefin was reported as >2000 mg/kg in rabbits. The results of this study indicate that hex-1-ene is not acutely toxic by the dermal exposure route.

In an acute dermal toxicity study on oct-1-ene (Neodene 8 alpha olefin), groups of New Zealand rabbits (8/sex) were exposed to 2 mL/kg of undiluted test substance for 24 hours under occlusion (Jud et al., 1983). The test site was abraded in four animals per sex and treatment, and intact in the others. The animals were then observed for 14 days. There was no treatment-related lethality, clinical signs of toxicity, changes in body weight, or necropsy findings. The only notable finding was mild to moderate skin irritation following the removal of the wrappings at 24 hours. Mild skin irritation was still present on day 14. Skin irritation was not effected by abrading the skin. The dermal LD50 was determined to be greater than 2.0 mL/kg (equivalent to > 1430 mg/kg using a density of 0.7149 g/cm3 for oct-1 -ene) in male and female rabbits.

The acute dermal toxicity of hexadecane was investigated by Kuhne (1993). In this study, five male and female New Zealand White rabbits were clipped free of hair on the dorsal surface of the trunk and treated with 2020 mg/kg (2.37 mL/kg) undiluted test substance under occlusion 24 hours. Body weight gain was not affected by treatment, however, one male that died on day 14 lost weight during the study. There were no signs of dermal irritation during the 14 day observation period, while gross necropsy at study termination revealed no observable abnormalities in most animals. However, the male that died on day 14 of the study revealed mottled lungs with white nodules. None of the other treated animals died during the course of the study. Based on these results, the LD50 for hexadecene in albino rabbits is > 2020 mg/kg (2.37 mL/kg). The results from this study indicate that hexadecene does not cause acute systemic toxicity following a single dermal application to the skin.

In an acute dermal toxicity study on octadecene, five male and female New Zealand White rabbits were clipped free of hair on the dorsal surface of the trunk and the test substance applied at mg/kg bw for 24 hours under occlusion (Kuhn, 1993). Body weight gain was affected by octadecene treatment. Four males and females either lost weight or failed to gain weight between days 7 and 14, however all animals survive to the end of the test. There were no signs of dermal irritation during the 14 day observation period and with the exception of one female with slight diarrhoea on days 9 and 10 clinical observations were unremarkable. Gross necropsy at study termination revealed no observable abnormalities. Based on these results, the LD50 for octadecene in albino rabbits is > 2020 mg/kg (2.35 mL/kg). The results from this study suggest that octadecene does not cause systemic toxicity following a single application to the skin.

Justification for selection of acute toxicity – oral endpoint
Acute oral toxicity testing has been conducted on 12 members of this category ranging from C6 to C24-28. The results of these studies demonstrate that higher olefins are not acutely hazardous after ingestion.

Justification for selection of acute toxicity – inhalation endpoint
Acute inhalation toxicity testing has been conducted on 6 members of this category ranging from C6 to C10/C11/c12/C13. The results of these studies demonstrate that higher olefins are not acutely hazardous after inhalation.

Justification for selection of acute toxicity – dermal endpoint
Acute dermal toxicity testing has been conducted on 9 members of this category ranging from C6 to C20-24. The results of these studies demonstrate that higher olefins are not acutely hazardous after skin contact.

Justification for classification or non-classification

Acute toxicity testing has been conducted on 16 members of the Higher Olefins category, including 12 acute oral studies (covering C6 – C24-28), 6 acute inhalation studies (covering C6 – C10/C11/C12/C13) and 9 acute dermal studies (covering C6-C20-24).

Two acute oral toxicity studies. Were conducted on the analogue read-across source substance Oct-1 -ene.

In an acute oral toxicity study on Oct-1 -ene (Wilborn 1983), groups of fasted, male and female Fischer 344 rats (5/sex) were given a single oral dose of Neodene 8 Alpha Olefin (undiluted) at a single dose of 5.0 mL/kg via oral intubation. The animals were subsequently observed for 14 days. 

There was no mortality observed in either male or female rats treated orally with Neodene 8 Alpha Olefin. There were no treatment related clinical signs, necropsy findings or changes in body weight observed through the 14 days study period. Based on the lack of significant treatment-related signs of clinical toxicity, the acute oral LD50 was determined to > 5.0 mL/kg in males and females.

In an acute oral toxicity study on Oct-1 -ene (Monrose 1973) , 10 fasted, male Sprague-Dawley rats were given a single oral dose of undiluted 1-octene at a dose of 10,000 mg/kg and observed for 14 days. There were no treatment related clinical signs, necropsy findings or changes in body weight reported in the study. The oral LD50 was determined to be greater than 10,000 mg/kg in males.

In an acute dermal toxicity study on Oct-1 -ene, four albino rabbits were dermally exposed to undiluted alpha olefin C6 for 24 hours at a dose of 10 g/kg bw. Animals then were observed for 14 days.

 

No treatment-related mortalities were observed. The skin of all animals was taut, dry, and scaly. Clipped areas of skin did not exhibit regrowth of hair and areas wetted by administration of the test material displayed loss of hair. Autopsy showed no sign of damage to internal organs and slight signs of pneumonia was observed in both control and treated animals. The dermal LD50 was determined to be greater than 10 g/kg in male rabbits.

Read-across of these results to the target substance, Oct-2 -ene, is claimed as valid basd on the justifications provided.

Based on the results obtained, no classification for acute toxicity is necessary according to the CLP regulation.