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

Poly alpha olefins and their respective structural analogues were not acutely toxic when administered via oral or dermal routes in several animal studies. Hence, these substances do not meet the classification and labelling criteria for acute oral or dermal toxicants as defined by CLP EU Regulation 1272/2008 (GHS aligned) criteria; therefore DNELs were not derived for these endpoints. 

 

In the studies that concluded an LC50 of lower than 5 mg/L, deaths can be attributed entirely to chemical pneumonitis, with the primary reported effects being reported being dark red lung tissue. The concentrations required to achieve these results do not represent a realistic scenario of how PAOs would behave in normal atmospheric conditions. The key value for vapour pressure given for PAOs is 1.889 Pa. This is so low that PAOs are not expected to volatilise and thus, an acute toxicity inhalation hazard is not deemed to be relevant. Therefore, DNELs have not been derived. 

 

Regulatory classification and labeling 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. The reported kinematic viscosity value for dec-1-ene dimers, hydrogenated is 5.1 cSt (Chevron Phillips Chemical Company, 2002). This value meets the criteria for classification as an aspiration toxicant under EU CLP (< 20.5 cSt) regulations. Dec-1-ene dimers, hydrogenated is classified as a Category 1 aspiration toxicant under EU CLP regulation 1272/2008 (GHS aligned). A DNEL is neither feasible nor appropriate for this endpoint.

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

Poly alpha olefins and their respective structural analogues were not acutely toxic when administered via oral or dermal routes in several animal studies. Hence, these substances do not meet the classification and labelling criteria for acute oral or dermal toxicants as defined by CLP EU Regulation 1272/2008 (GHS aligned) criteria; therefore DNELs were not derived for these endpoints. 

 

In the studies that concluded an LC50 of lower than 5 mg/L, deaths can be attributed entirely to chemical pneumonitis, with the primary reported effects being reported being dark red lung tissue. The concentrations required to achieve these results do not represent a realistic scenario of how PAOs would behave in normal atmospheric conditions. The key value for vapour pressure given for PAOs is 1.889 Pa. This is so low that PAOs are not expected to volatilise and thus, an acute toxicity inhalation hazard is not deemed to be relevant. Therefore, DNELs have not been derived. 

 

Regulatory classification and labeling 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. The reported kinematic viscosity value for dec-1-ene dimers, hydrogenated is 5.1 cSt (Chevron Phillips Chemical Company, 2002). This value meets the criteria for classification as an aspiration toxicant under EU CLP (< 20.5 cSt) regulations. Dec-1-ene dimers, hydrogenated is classified as a Category 1 aspiration toxicant under EU CLP regulation 1272/2008 (GHS aligned). A DNEL is neither feasible nor appropriate for this endpoint.