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Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
23.5 mg/m³
Most sensitive endpoint:
repeated dose toxicity
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:
33.33 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
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 systemic DNELs for workers are based on a subacute 28 day oral gavage study performed on Decyl oleate (CAS No.): 3687-46-5, in which the oral 28d NOAEL for rat was found to be 1000 mg/kg bw/day.

DNELs were derived based on guidance document R8 (ECHA 2008).

 Long-Term exposure-Systemic effects.

Dermal DNEL:

Assessment factors: inter species 4; remaining differences 2.5, intra species factor 5, and exposure duration factor 6.

Overall AF= 300

Rat oral NOAEL = 1000 mg/ kg bw/day

A dermal absorption difference of 10% was used to modify the dose to the correct starting dose.

NAELcorr= 1000 mg/kg bw/d / 0.1 = 10000 mg/kg bw/day

DNEL = NAEL / AF = 10000 mg/kg bw/d / 300 = 33.3 mg/kg bw/day

 

Inhalation DNEL:

Assessment factors: inter species 2.5, intra species factor 5, and exposure duration factor 6.

Overall AF = 75

Rat oral NOAEL = 1000 mg/ kg bw/day

For calculating inhalation DNEL for workers, the oral NAELcorrneeds to be converted into an inhalatory NAECcorr rat by application of route-to route extrapolation:

NAECcorr= NAELcorr x 1/0.38 x 6.7/10 = 1763 mg/m3/d

DNEL = NAECcorr/ AF = 1763 mg/m3/ 75 = 23.5 mg/m3

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
4.14 mg/m³
Most sensitive endpoint:
repeated dose toxicity
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:
11.9 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
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:
1.19 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
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 systemic DNELs for consumers are based on a subacute 28 day oral gavage study performed on Decyl oleate (CAS No.): 3687-46-5, in which the oral 28d NOAEL for rat was found to be 1000 mg/kg bw/day.

DNELs were derived based on guidance document R8 (ECHA 2008).

Dermal DNEL:

Assessment factors: inter species 4, remaining differences 2.5, intra species factor 10, and exposure duration factor 6.

Overall AF= 600

A dermal absorption difference of 10% and a factor of 5/7 (as the substance was adminstered 5 days/week) was used to modify the NOAEL to the correct starting dose. NAELcorr= 1000 x 5/7 / 0.1 = 7143 mg/kg bw/day

DNEL = NAEL / AF = 7143 mg/kg bw/d / 600= 11.9 mg/kg bw/day

 

Inhalation DNEL:

Assessment factors: inter species 2.5, intra species factor 10, and exposure duration factor 6.

Overall AF= 150

Rat oral NOAEL = 1000 mg/ kg bw/day

Since the substance was administered 5 days/ week a factor of 5/7 was used to modify the NOAEL to the correct starting dose. NAELcorr = 1000 mg/kg bw/d x 5/7 = 714.3 mg/kg bw/d

For calculating inhalation DNEL for consumers, the oral NAELcorr needs to be converted into an inhalatory NAECcorr rat by application of route-to route extrapolation:

NAECcorr= NAELcorr x 1 / 1.15 = 621.1 mg/m3

DNEL = NAECcorr / AF = 621.1 mg/m3/ 150 = 4.14 mg/m3

 

Oral DNEL:

Assessment factors: Inter species factor 2.5, allometric scaling factor 4, intra species factor 10, and exposure duration factor 6.

Overall AF= 600

The long-term DNELs are based on a subacute 28 day oral gavage study performed on Decyl oleate (CAS No.): 3687-46-5, in which the oral 28d NOAEL for rat was found to be 1000 mg/kg bw/day. A factor of 5/7 (substance was adminsitered 5 days/week) was used to modify the NOAEL to the correct starting dose.

NAELcorr= 1000 mg/kg bw/d x 5/7 = 714 mg/kg bw/day

DNEL = NAELcorr / AF = 714 mg/kg bw/d / 600=1.19 mg/kg bw/day

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