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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
0.04 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:
0.4 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
0.987 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point cross-reading NOAEL 90-day on C12-14-Diamine: 0.4 mg/kgbw/d (justification see section 7.5 repeated dose). The corrected 8 hr inhalation NOAEC for workers is NOAEL(0.4 mg/kg) * 1.76 (1/0.38 * 6.7/10)  * 0.714 (correction daily to workweek 5/7)  = 0.987 mg/m3. No factor 2 route extrapolation from oral to inhalation is applied: Due to very low vp (< 0.0015 Pa), exposure is only possible as aerosol. If any inhalation does occur, this can only be in the form of larger droplets, as the use does not include fine spraying. Droplets will deposit mainly on upper airways, and will be subsequently swallowed following mucociliary transportation to pharynx. This results to no principal difference in absorption compared oral route.

AF for dose response relationship:
1
Justification:
No specific concerns; starting point is NOAEL, effects at LOAEL are not severe and of local nature.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor for sub-chronic to chronic. However, we know that the dose levels of the NOAEL for this effect of foamy macrophages in mesenteric lymph nodes is not influenced by the duration of the study.
AF for interspecies differences (allometric scaling):
1
Justification:
Already included in NOAEC calculation
AF for other interspecies differences:
2.5
Justification:
Default. Conservative approach as effects are interpreted as being local and related to the route of exposure (see comments), the already applied allometric scaling already represents a worst case.
AF for intraspecies differences:
5
Justification:
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:
The NOAEL of 0.4 mg/kgbw/d is based on effects observed of foamy macrophages seen at higher dose levels of 1.5 and 6 mg/kg. The effects are comparable and evaluated similar as in all other studies involving primary amine structures, and are considered to be of a non-adverse and local nature. This NOAEL therefore represents a very conservative level. Additional conservatism is included with the read-across to a smaller alkyl chain which is linked to higher toxicity.
Acute/short term exposure
Hazard assessment conclusion:
low hazard (no threshold derived)
Most sensitive endpoint:
repeated dose toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.006 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:
0.4 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
0.56 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point cross-reading NOAEL 90-day on C12-14-Diamine: 0.4 mg/kgbw/d (justification see section 7.5 repeated dose). At this stage no data are available on dermal absorption. Diamines  and  diamine ethoxylated are not expected to easily pass the skin. However, as this is not quantitatively evaluated, 100% dermal absorption is considered as worst case assumption. The corrected dermal NOAEL for workers isNOAEL(0.4 mg/kg) * 0.714 (correction daily to workweek 5/7) = 0.56 mg/kg bw/day.

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. However, we know that the dose levels of the NOAEL for this effect of foamy macrophages in mesenteric lymph nodes is not influenced by the duration of the study.
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:
Default. Conservative approach as effects are interpreted as being local and related to the route of exposure (see comments), the already applied allometric scaling already represents a worst case.
AF for intraspecies differences:
5
Justification:
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 extended studies on non-ethoxylated amines does also not indicate additional concerns to be considered.
Additional conservatism is included with the read-across to a smaller alkyl chain which is linked to higher toxicity.
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

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:
DNEL (Derived No Effect Level)
Value:
0.007 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
Dose descriptor starting point:
NOAEL
Value:
0.4 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
0.348 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point cross-reading NOAEL 90-day on C12-14-Diamine: 0.4 mg/kgbw/d (justification see section 7.5 repeated dose). The corrected 24 hr inhalation NOAEC for general public is NOAEL(0.4 mg/kg) * 0.740 (1/1.15) = 0.348 mg/m3. No factor 2 route extrapolation from oral to inhalation is applied: Due to very low vp (< 0.0015 Pa), exposure is only possible as aerosol. Further, there are no uses for the general public, and thus no direct exposure to the general population / consumers.

AF for dose response relationship:
1
Justification:
No specific concerns; effects at LOAEL are not severe and of local nature.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor for sub-chronic to chronic. However, we know that the dose levels of the NOAEL for this effect of foamy macrophages in mesenteric lymph nodes is not influenced by the duration of the study.
AF for interspecies differences (allometric scaling):
1
Justification:
Already included in NOAEC calculation
AF for other interspecies differences:
2.5
Justification:
Default.
AF for intraspecies differences:
10
Justification:
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:
The NOAEL of 0.4 mg/kgbw/d is based on effects observed of foamy macrophages seen at higher dose levels of 1.5 and 6 mg/kg. The effects are comparable and evaluated similar as in all other studies involving primary amine structures, and are considered to be of a non-adverse and local nature. This NOAEL therefore represents a very conservative level. Additional conservatism is included with the read-across to a smaller alkyl chain which is linked to higher toxicity.
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:
0.002 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
Dose descriptor starting point:
NOAEL
Value:
0.4 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
0.4 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point cross-reading NOAEL 90-day on C12-14-Diamine: 0.4 mg/kgbw/d (justification see section 7.5 repeated dose). At this stage no data are available on dermal absorption. Diamines  and  diamine ethoxylated are not expected to easily pass the skin. However, as this is not quantitatively evaluated, 100% dermal absorption is considered as worst case assumption.

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. However, we know that the dose levels of the NOAEL for this effect of foamy macrophages in mesenteric lymph nodes is not influenced by the duration of the study.
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:
Default
AF for intraspecies differences:
10
Justification:
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 extended studies on non-ethoxylated amines does also not indicate additional concerns to be considered.
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:
DNEL (Derived No Effect Level)
Value:
0.002 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
Dose descriptor starting point:
NOAEL
Value:
0.4 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
0.4 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Not applicable as study was performed by oral route

AF for dose response relationship:
1
Justification:
No specific concerns; effects at LOAEL are not severe and of local nature.
AF for differences in duration of exposure:
2
Justification:
Default assessment factor for sub-chronic to chronic. However, we know that the dose levels of the NOAEL for this effect of foamy macrophages in mesenteric lymph nodes is not influenced by the duration of the study.
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:
Default.
AF for intraspecies differences:
10
Justification:
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 extended studies on non-ethoxylated amines does also not indicate additional concerns to be considered.
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

The uses indicated in this dossier are limited to industrial and professional users and exposure of the general population to Oleyl-diamine3EO are not to be expected.

However, to allow for evaluation from indirect exposures via the environment, DNELs have been derived for systemic toxicity from long term exposures via all routes.