Alkenes, C9-13-branched, C10-rich

Acute Toxicity: other routes

Administrative data

Endpoint:

acute toxicity: other routes

Type of information:

experimental study

Adequacy of study:

key study

Study period:

1963

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified reliable with restrictions, because although the study was well conducted, there is no statement regarding whether this study was conducted according to GLP or equivalent.

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: other routes

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

1963

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: This study is classified reliable with restrictions, because although the study was well conducted, there is no statement regarding whether this study was conducted according to GLP or equivalent.

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:

no guideline followed

Principles of method if other than guideline:

Though the study did not follow a prescribed guideline, it was well conducted and documented.

GLP compliance:

no

Limit test:

no

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not provided
- Age at study initiation: Not provided
- Weight at study initiation: 200 to 300 grams
- Fasting period before study: Not reported
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

Route of administration:

other: other: Material delivered into the mouth as a liquid or an aerosol

Vehicle:

unchanged (no vehicle)

Details on exposure:

Test material was administered into the animals mouth and was allowed to aspirate.

Doses:

Until all of the administered test material had been aspirated; specific duration is not reported.

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Groups of 5 anesthetized male albino Wistar rats were either administered 0.2 millilitre or 1 millilitre of liquid or aerosolised test material respectively into the mouth. When breathing resumed and was regular after test material administration, the animals’ nostrils were closed with fingers during the end of expiration phase to promote aspiration of the test material. This process was repeated until all of the test material had been aspirated. After dosing, animals were observed for a minimum of 4 hours at intervals ranging from 5 to 30 minutes. Animals that survived for 24 hours were sacrificed and lungs were weighed and received gross necropsy. Twenty undosed animals served as controls.

Statistics:

No data reported.

Sex:

male

Dose descriptor:

other: Aspiration hazard

Effect level:

other: 1-Decene is toxic when aspirated causing rapid death in all of the five treated animals.

Mortality:

All five rats receiving 1 -decene died within 24 hours.

Clinical signs:

No data reported.

Body weight:

No data reported.

Gross pathology:

Since 1-decene aspirated readily, the differences found in the lungs of the treated animals were based on extent of penetration into deep lung structures and/or endothelial toxicity rather than differences in the amount of test material entering the trachea. Lung weights of these animals were higher than lung weights in control animals, but not significantly different. Study authors reported that grossly, pathologically, lungs of these animals displayed typical “liver-like lungs.”

Conclusions:

The study authors concluded that 1-decene is toxic when aspirated causing rapid death in all of the five treated animals. A quantitative estimate of toxicity was not reported.

Executive summary:

In an acute toxicity study, eight homologous series of n-alkenes (n-olefins), including 1-decene, were evaluated for their potential to cause acute toxicity using an aspiration process. Groups of 5 anesthetized male albino Wistar rats were either administered 0.2 millilitre or 1 millilitre of liquid or aerosolized test material respectively into the mouth. When breathing resumed and was regular after test material administration, the animals’ nostrils were closed with fingers during the end of expiration phase to promote aspiration of the test material. This process was repeated until all of the test material had been aspirated. After dosing, animals were observed for a minimum of 4 hours at intervals ranging from 5 to 30 minutes. Animals that survived for 24 hours were sacrificed and lungs were weighed and received gross necropsy.

All five rats receiving 1 -decene died within 24 hours. Since 1-decene aspirated readily, the differences found in the lungs of the treated animals were based on extent of penetration into deep lung structures and/or endothelial toxicity rather than differences in the amount of test material entering the trachea. Lung weights of these animals were higher than lung weights in control animals, but not significantly different. Study authors reported that grossly, pathologically, lungs of these animals displayed typical “liver-like lungs.” A quantitative estimate of acute toxicity was not reported for this study.

Based on the study outcome, the study authors concluded that 1 -decene is toxic when aspirated causing rapid death in all five treated animals.

This study received a Klimisch score of 2 and is classified as “reliable with restrictions”because although the study was well conducted, there is no statement regarding whether this study was conducted according to GLP or equivalent. 

Data source

Reference

Reference Type:

publication

Title:

Unnamed

Year:

1963

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

Though the study did not follow a prescribed guideline, it was well conducted and documented.

GLP compliance:

no

Limit test:

no

Test material

Test material information

Constituent 1

Reference substance name:

Dec-1-ene

EC Number:

212-819-2

EC Name:

Dec-1-ene

Cas Number:

872-05-9

Molecular formula:

C10H20

IUPAC Name:

dec-1-ene

Details on test material:

- Name of test material (as cited in study report): 1-Decene
- Substance type: C10 alpha olefin

Test animals

Species:

rat

Strain:

Wistar

Sex:

male

Details on test animals or test system and environmental conditions:

TEST ANIMALS
- Source: Not provided
- Age at study initiation: Not provided
- Weight at study initiation: 200 to 300 grams
- Fasting period before study: Not reported
- Housing: No data
- Diet (e.g. ad libitum): No data
- Water (e.g. ad libitum): No data
- Acclimation period: No data

Administration / exposure

Route of administration:

other: other: Material delivered into the mouth as a liquid or an aerosol

Vehicle:

unchanged (no vehicle)

Details on exposure:

Test material was administered into the animals mouth and was allowed to aspirate.

Doses:

Until all of the administered test material had been aspirated; specific duration is not reported.

No. of animals per sex per dose:

5

Control animals:

yes

Details on study design:

Groups of 5 anesthetized male albino Wistar rats were either administered 0.2 millilitre or 1 millilitre of liquid or aerosolised test material respectively into the mouth. When breathing resumed and was regular after test material administration, the animals’ nostrils were closed with fingers during the end of expiration phase to promote aspiration of the test material. This process was repeated until all of the test material had been aspirated. After dosing, animals were observed for a minimum of 4 hours at intervals ranging from 5 to 30 minutes. Animals that survived for 24 hours were sacrificed and lungs were weighed and received gross necropsy. Twenty undosed animals served as controls.

Statistics:

No data reported.

Results and discussion

Effect levels

Sex:

male

Dose descriptor:

other: Aspiration hazard

Effect level:

other: 1-Decene is toxic when aspirated causing rapid death in all of the five treated animals.

Mortality:

All five rats receiving 1 -decene died within 24 hours.

Clinical signs:

No data reported.

Body weight:

No data reported.

Gross pathology:

Since 1-decene aspirated readily, the differences found in the lungs of the treated animals were based on extent of penetration into deep lung structures and/or endothelial toxicity rather than differences in the amount of test material entering the trachea. Lung weights of these animals were higher than lung weights in control animals, but not significantly different. Study authors reported that grossly, pathologically, lungs of these animals displayed typical “liver-like lungs.”

Applicant's summary and conclusion

Conclusions:

The study authors concluded that 1-decene is toxic when aspirated causing rapid death in all of the five treated animals. A quantitative estimate of toxicity was not reported.

Executive summary:

In an acute toxicity study, eight homologous series of n-alkenes (n-olefins), including 1-decene, were evaluated for their potential to cause acute toxicity using an aspiration process. Groups of 5 anesthetized male albino Wistar rats were either administered 0.2 millilitre or 1 millilitre of liquid or aerosolized test material respectively into the mouth. When breathing resumed and was regular after test material administration, the animals’ nostrils were closed with fingers during the end of expiration phase to promote aspiration of the test material. This process was repeated until all of the test material had been aspirated. After dosing, animals were observed for a minimum of 4 hours at intervals ranging from 5 to 30 minutes. Animals that survived for 24 hours were sacrificed and lungs were weighed and received gross necropsy.

All five rats receiving 1 -decene died within 24 hours. Since 1-decene aspirated readily, the differences found in the lungs of the treated animals were based on extent of penetration into deep lung structures and/or endothelial toxicity rather than differences in the amount of test material entering the trachea. Lung weights of these animals were higher than lung weights in control animals, but not significantly different. Study authors reported that grossly, pathologically, lungs of these animals displayed typical “liver-like lungs.” A quantitative estimate of acute toxicity was not reported for this study.

Based on the study outcome, the study authors concluded that 1 -decene is toxic when aspirated causing rapid death in all five treated animals.

This study received a Klimisch score of 2 and is classified as “reliable with restrictions”because although the study was well conducted, there is no statement regarding whether this study was conducted according to GLP or equivalent.