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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
70.52 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Modified dose descriptor starting point:
NOAEC
Value:
1 763.16 mg/m³
Explanation for the modification of the dose descriptor starting point:

This summary is based on a read-across to oleyl palmitamide (CAS 16260 -09 -6).

NOAECcorr=NOAELoral*(1/0.38 m³/kg/d)*(ABSoral-rat/ABSinh-human)*(6.7 m³ (8h)/10 m³ (8h)) = 1000 mg/kg/d*(1/0.38 m³/kg/d)*(1/1)*0.67 = 1763.16 mg/m³. ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans.

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
DNEL is based on an oral 90-day repeated-dose toxicity study in rats.
AF for interspecies differences (allometric scaling):
1
Justification:
AF for allometric scaling is already included in the ECHA starting point derivation method.
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
Justification:
For workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
DNEL (Derived No Effect Level)
Value:
20 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal NOAEL=NOAELoral*(ABSoral-rat/ABSdermal-human) = (1000 mg/kg bw/day)*(1/0.5) = 2000 mg/kg bw/day. Although the physicochemical properties (high molecular weight in combination with high log Pow and low water solubility) of the test substance do not suggest a significant absorption through the skin, the dermal absorption is assumed to be 50% compared to the oral route (factor: 1/0.5) in a worst-case approach and is considered as sufficiently conservative for hazard assessment. ABSoral-rat=oral absorption rate in rats, ABSdermal-human=dermal absorption rate in humans.

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a rat 90-day repeated-dose study with oleyl palmitamide (CAS 16260-09-6).
AF for interspecies differences (allometric scaling):
4
Justification:
DNEL is based on a rat oral repeated-dose study.
AF for other interspecies differences:
2.5
Justification:
For workers
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information
Explanation for the modification of the dose descriptor starting point:

Acute toxixity studies with the read across source substance did not show any adverse effects up and above the limit dose of the OECD guidance. QSAR predictions of the target substance predict equally low acute toxicity. Therfore no hazard was identified, no classification is proposed and no DNEL needs to be derived in accordance with ECHA guidance on information requirements and chemical safety assessment Part B.8 scope of the exposure assessment, verison 2.1, 2011. .

.

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
17.39 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
50
Modified dose descriptor starting point:
NOAEC
Value:
869.56 mg/m³
Explanation for the modification of the dose descriptor starting point:

This information is based upon a read-across from oleyl palmitamide (CAS 16260 -09 -6).

NOAECcorr=NOAELoral*(1/1.15 m³/kg/d)*(ABSoral-rat/ABSinh-human) = 1000 mg/kg/d*(1/1.15 m³/kg/d)*(1/1) = 869.56 mg/m³. ABSoral-rat=oral absorption rate in rats, ABSinh-human=inhalation absorption rate in humans.

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
DNEL is based upon a rat oral repeated-dose study using oleyl palmitamide.
AF for interspecies differences (allometric scaling):
1
Justification:
AF for allometric scaling already included in ECHA starting point derivation method - no further factor is required.
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
For the general population.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
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:
DNEL (Derived No Effect Level)
Value:
10 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
2 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal NOAEL=NOAELoral*(ABSoral-rat/ABSdermal-human) = (1000 mg/kg bw/day)*(1/0.5) = 2000 mg/kg bw/day. Although the physicochemical properties (high molecular weight in combination with high log Pow and low water solubility) of the test substance do not suggest a significant absorption through the skin, the dermal absorption is assumed to be 50% compared to the oral route (factor: 1/0.5) in a worst-case approach and is considered as sufficiently conservative for hazard assessment. ABSoral-rat=oral absorption rate in rats, ABSdermal-human=dermal absorption rate in humans.

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a rat oral 90-day repeated-dose study using oleyl palitamide.
AF for interspecies differences (allometric scaling):
4
Justification:
DNEL is based on a rat oral 90-day repeated-dose study using oleyl palitamide.
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
For the general population.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Dermal
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
200
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No route-to-route extrapolation is needed.

AF for dose response relationship:
1
AF for differences in duration of exposure:
2
Justification:
DNEL is based on a rat oral 90-day repeated-dose study using oleyl palitamide.
AF for interspecies differences (allometric scaling):
4
Justification:
DNEL is based on a rat oral 90-day repeated-dose study using oleyl palitamide.
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
Justification:
For the general population.
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population