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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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