Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.5 mg/m³
DNEL related information
Overall assessment factor (AF):
75
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
33 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
300
Acute/short term exposure
DNEL related information

Workers - Hazard for the eyes

Additional information - workers

The long-term DNELs are based on a subacute 28 day oral gavage study in rats (Pittermann, 1992).

The oral subacute NOAEL for Fatty acids, C16-18, 2-ethylhexyl esters was found to be 1000 mg/kg bw/d.

Dermal DNEL:

QSAR based dermal permeability regarding molecular weight, log Pow and water solubility, calculated a very low dermal absorption for the read across substance 2-ethylhexyl palmitate (CAS No. 29806 -73 -3, see section 7.1.2, Danish EPA, 2010). Therefore, assuming a dermal absorption of 10% for the very similar substance C16-18, 2-ethylhexyl esters (CAS No. 91031 -48 -0) displays a sufficient conservative approach.

Assessment factors were used according to the "Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health", ECHA, May 2008.

Inhalation DNEL worker:

The NAEC was determined by calculating from oral exposure to 8h inhalation exposure by factor 0.38 and allometric scaling from rat to human worker by factor 0.67 according to the "Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health", ECHA, May 2008

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5.79 mg/m³
DNEL related information
Overall assessment factor (AF):
150
Acute/short term exposure
DNEL related information

Local effects

Acute/short term exposure
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
16 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
600
Acute/short term exposure
DNEL related information

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.6 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
600
Acute/short term exposure
DNEL related information

General Population - Hazard for the eyes

Additional information - General Population

The long-term DNELs are based on a subacute 28 day oral gavage study in rats (Pittermann, 1992).

The oral subacute NOAEL for Fatty acids, C16-18, 2-ethylhexyl esters was found to be 1000 mg/kg bw/d.

Assessment factors were used according to the "Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health", ECHA, May 2008.

Dermal DNEL:

QSAR based dermal permeability regarding molecular weight, log Pow and water solubility, calculated a very low dermal absorption for the read across substance 2-ethylhexyl palmitate (CAS No. 29806 -73 -3, see section 7.1.2, Danish EPA, 2010). Therefore, assuming a dermal absorption of 10% for the very similar substance C16-18, 2-ethylhexyl esters (CAS No. 91031 -48 -0) displays a sufficient conservative approach.

Inhalation DNEL - general population:

The NAEC was determined by calculating from oral exposure to 8h inhalation and allometric scaling from rat to human worker by factor 1.15 according to the "Guidance on information requirements and chemical safety assessment Chapter R.8: Characterisation of dose [concentration]-response for human health", ECHA, May 2008.