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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.074 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
Dose descriptor starting point:
NOAEL
Value:
0.75 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1.85 mg/m³
Explanation for the modification of the dose descriptor starting point:

The default calculator has been applied: Starting point is read-across to NOAEL 90-day on C12-14-Diamine: 0.4 mg/kgbw/d; Based on Oleyl-diamine content in Oleyl-diamine mono-oleate of 53.5%, this equals a NOAEL of 0.75 mg/kg bw/d for Oleyl-diamine mono-oleate.

The corrected 8 hr inhalation NOAEC for workers is calculated applying the default calculation: oral NOAELrat * 1/0.38  * 6.7/10. Additionally, a correction for differences between human and experimental exposure conditions of 1.4 is added (5 d/w versus experimental daily exposure). This results to a NOAEC workers of 1.85 mg/m3.

No factor 2 route extrapolation from oral to inhalation is applied: Oleyl-diamine mono-oleate is a paste with a very low vapour pressure of ≤ 0.00087 Pa at 25 °C. Exposure by inhalation would only be possible in the form of aerosol, consisting of larger droplets depositing in upper airways. Aerosols will deposit mainly on upper airways, and will be subsequently swallowed following mucociliary transportation to pharynx. This result to no principal difference in absorption compared to oral route.

AF for dose response relationship:
1
Justification:
No specific concerns; starting point is NOAEL, effects at LOAEL are not severe and probably of local nature.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor for sub-chronic to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
Already included in NOAEC calculation
AF for other interspecies differences:
2.5
Justification:
ECHA default.
AF for intraspecies differences:
5
Justification:
ECHA default.
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results within category.
AF for remaining uncertainties:
1
Justification:
Cross-reading to more studies on similar amine structures does not indicate additional concerns to be considered.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.01 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
Dose descriptor starting point:
NOAEL
Value:
0.75 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1.05 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

The default calculator has been applied: Starting point is read-across to the NOAEL from 90-day study on C12-14-Diamine: 0.4 mg/kgbw/d. Based on Oleyl-diamine content in Oleyl-diamine mono-oleate of 53.5%, this equals a NOAEL of 0.75 mg/kg bw/d for Oleyl-diamine mono-oleate.

At this stage no data are available on dermal absorption. Diamines are not expected to easily pass the skin in view of its ionised form at physiological conditions. However, as this is not quantitatively evaluated, 100% dermal absorption is considered as worst-case assumption. Additionally a correction for differences between human and experimental exposure conditions of 1.4 is added (5 d/w versus experimental daily exposure): 8hr-NOAEL workers = NOAEL(0.75 mg/kg) * 1.4 = 1.05 mg/kg bw/d.

AF for dose response relationship:
1
Justification:
No specific concerns. Effects at LOAEL are not severe and probably only of local nature.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor for sub-chronic to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
Default factor for allometric scaling from rat to human.
AF for other interspecies differences:
2.5
Justification:
ECHA default.
AF for intraspecies differences:
5
Justification:
ECHA default.
AF for the quality of the whole database:
1
Justification:
Available data derived from valid studies showing consistent results within category.
AF for remaining uncertainties:
1
Justification:
Cross-reading to more studies on similar amine structures does not indicate additional concerns to be considered.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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

General Population - Hazard via oral route

Systemic 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 for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population

Oleyl-diamine mono-oleateis not used in the consumer sector.

Also assessment of indirect exposure is not needed as the tonnage is not above 1000 tpa, and the substance not is classified as CMR or toxic STOT-RE Cat.1.