Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - workers

The weight of evidence from the available toxicological information on higher olefins shows that the members of this category have a low hazard potential with regard to human health, with dermal irritation the only effect recorded for some materials. As there are no quantifiable toxicological effects for these substances, DNELs have not been derived.

Acute toxicity

The higher olefins included in this category were not acutely toxic when administered via oral, dermal, or inhalation routes in several animal studies. Hence, these substances do not meet the classification and labelling criteria for acute oral, dermal, or inhalation toxicity according to CLP Regulation 1272/2008. Therefore short-term DNELs will not be derived for these endpoints. In contrast, regulatory classification and labelling for aspiration toxicity relies on the measured or calculated kinematic viscosity of a substance at 40°C rather than results from toxicological studies with animals, with substances where the kinematic viscosity is less than 20.5 mm2/second requiring classified (Category 1 - H304: May be fatal if swallowed and enters airway). All higher olefins included in this category which exist as liquids at 40°C are therefore classified as aspiration hazards because their respective kinematic viscosities are below the discriminating threshold established in the CLP Regulation.

Repeated dose toxicity / toxicity to reproduction

Information on the potential of higher olefin substances included in this category to cause systemic toxicity and toxicity to reproduction is available from a number of studies as indicated in the table below:

 

Name

CAS

Carbon Number

Study design

Study type

Reference

Hex-1-ene

592-41-6

6

OECD 407

28-d

Dotti et al., 1994

Hex-1-ene

592-41-6

6

OECD 421

Repro/dev screen

Daniel et al., 1995

Hex-1-ene

592-41-6

6

OECD 413

90-d

Bennick et al., 1984

Hex-1-ene

592-41-6

6

OECD 408

90-d

Dotti et al., 1994

Alkenes, C6

68526-52-3

6

OECD 422

RDT and Repro/dev screen

Thorsrud, 2003

1-Tetradecene

1120-36-1

14

OECD 422

RDT and Repro/dev screen

Daniel, 1995

Alkenes C16-18

none

16-18

OECD 424

Neurotox

Clubb, 2000

Octadecene

27070-58-2

18

OECD 421

Repro/dev screen

Thorsrud, 2003

Alkenes C20-24

68914-55-6

20-24

OECD 407

28-d

Dunster, 2008

Alkenes C20-24

68914-55-6

20-24

OECD 408

90-d

Brooker, 1999

 

The results from these tests showed no adverse substance-related effects after treatment via oral or inhalation exposure. Hence, these substances do not meet the classification and labelling criteria for repeated toxicity or toxicity to reproduction according to CLP Regulation 1272/2008. Therefore long-term DNELs will not be derived for these endpoints.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

The weight of evidence from the available toxicological information on higher olefins shows that the members of this category have a low hazard potential with regard to human health, with dermal irritation the only effect recorded for some materials. As there are no quantifiable toxicological effects for these substances, DNELs have not been derived.

Acute toxicity

The higher olefins included in this category were not acutely toxic when administered via oral, dermal, or inhalation routes in several animal studies. Hence, these substances do not meet the classification and labelling criteria for acute oral, dermal, or inhalation toxicity according to CLP Regulation 1272/2008. Therefore short-term DNELs will not be derived for these endpoints. In contrast, regulatory classification and labelling for aspiration toxicity relies on the measured or calculated kinematic viscosity of a substance at 40°C rather than results from toxicological studies with animals, with substances where the kinematic viscosity is less than 20.5 mm2/second requiring classified (Category 1 - H304: May be fatal if swallowed and enters airway). All higher olefins included in this category which exist as liquids at 40°C are therefore classified as aspiration hazards because their respective kinematic viscosities are below the discriminating threshold established in the CLP Regulation.

Repeated dose toxicity / toxicity to reproduction

Information on the potential of higher olefin substances included in this category to cause systemic toxicity and toxicity to reproduction is available from a number of studies as indicated in the table below:

 

Name

CAS

Carbon Number

Study design

Study type

Reference

Hex-1-ene

592-41-6

6

OECD 407

28-d

Dotti et al., 1994

Hex-1-ene

592-41-6

6

OECD 421

Repro/dev screen

Daniel et al., 1995

Hex-1-ene

592-41-6

6

OECD 413

90-d

Bennick et al., 1984

Hex-1-ene

592-41-6

6

OECD 408

90-d

Dotti et al., 1994

Alkenes, C6

68526-52-3

6

OECD 422

RDT and Repro/dev screen

Thorsrud, 2003

1-Tetradecene

1120-36-1

14

OECD 422

RDT and Repro/dev screen

Daniel, 1995

Alkenes C16-18

none

16-18

OECD 424

Neurotox

Clubb, 2000

Octadecene

27070-58-2

18

OECD 421

Repro/dev screen

Thorsrud, 2003

Alkenes C20-24

68914-55-6

20-24

OECD 407

28-d

Dunster, 2008

Alkenes C20-24

68914-55-6

20-24

OECD 408

90-d

Brooker, 1999

 

The results from these tests showed no adverse substance-related effects after treatment via oral or inhalation exposure. Hence, these substances do not meet the classification and labelling criteria for repeated toxicity or toxicity to reproduction according to CLP Regulation 1272/2008. Therefore long-term DNELs will not be derived for these endpoints.