Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
25.85 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:
36.6 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 performed with the Read Across substance isopropyl myristate (CAS No. 110 -27 -0), in which the oral 28d NOAEL for rats was found to be 1000 mg/kg bw/d.

This refers to a 28 -day oral equimolar NAEL for isopropyl palmitate of 1100 mg/kg bw/d.

A conversion factor on molar basis of 1.10 (298.51/270.46) was used as calculated from the MW of isopropyl palmitate (298.51)

and the MW of isopropyl myristate (270.46). Conversion factor: = 1.10

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 isopropyl palmitate (see section 7.1.2, Danish EPA, 2010). Therefore, assuming a dermal absorption of 10% displays a sufficient conservative approach.

 

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:
6.37 mg/m³
DNEL related information
Overall assessment factor (AF):
150
Modified dose descriptor starting point:
NOAEC
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:
18.3 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
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:
1.83 mg/kg bw/day
DNEL related information
Overall assessment factor (AF):
600
Modified dose descriptor starting point:
NOAEL
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 performed with the Read Across substance isopropyl myristate (CAS No. 110 -27 -0), in which the oral 28d NOAEL for rats was found to be 1000 mg/kg bw/d.

This refers to a 28 -day oral equimolar NAEL for isopropyl palmitate of 1100 mg/kg bw/d.

A conversion factor on molar basis of 1.10 (298.51/270.46) was used as calculated from the MW of isopropyl palmitate (298.51)

and the MW of isopropyl myristate (270.46). Conversion factor: = 1.10

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 isopropyl palmitate (see section 7.1.2, Danish EPA, 2010). Therefore, assuming a dermal absorption of 10% 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.