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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
5.92 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:
60 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
148 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point: 90-day (OECD 408) repeated dose toxicity study with Coco amidopropyldimethylamine resulted to a NOAEL for systemic toxicity of 60 mg/kg bw. Besides effects of local toxicity (morphological alterations in the non-glandular stomach), ‘No toxicologically significant changes were noted in any of the remaining parameters’.

The corrected 8h inhalation NOAEC for workers is NOAEL (60 mg/kg) * 1.76 mg/m3 * 7/5 (correction worker exposure 5d/wk) = 148 mg/m3. No factor 2 route extrapolation from oral to inhalation. Due to very low vp (estimated 3.96 x 10-5 Pa) exposures via vapour are not significant. Exposure is only possible as aerosol or larger particles as the use does not include fine spraying. Droplets will deposit mainly on upper airways and will be subsequently swallowed following mucocilliary 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 for systemic effects.
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 study showing consistent results.
AF for remaining uncertainties:
1
Justification:
No uncertainties identified
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 (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:
0.84 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:
60 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
84 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point: 90-day (OECD 408) repeated dose toxicity study with Coco amidopropylenedimethylamine resulted to a NOAEL for systemic toxicity of 60 mg/kg bw. Besides effects of local toxicity (morphological alterations in the non-glandular stomach), ‘No toxicologically significant changes were noted in any of the remaining parameters’.

This substance is 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. The corrected 8h dermal NOAEL for workers is NOAEL (60 mg/kg) * 7/5 (correction worker exposure 5d/wk) = 84.0 mg/kg bw/d.

AF for dose response relationship:
1
Justification:
No specific concerns; starting point is NOAEL for systemic effects.
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 for workers
AF for the quality of the whole database:
1
Justification:
Available data derived from valid study showing consistent results with several studies.
AF for remaining uncertainties:
1
Justification:
No uncertainties identified
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)
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:
DNEL (Derived No Effect Level)
Value:
0.89 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:
60 ng/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
44.44 mg/m³
Explanation for the modification of the dose descriptor starting point:

Starting point: 90-day (OECD 408) repeated dose toxicity study with Coco amidopropyldimethylamine resulted to a NOAEL for systemic toxicity of 60 mg/kg bw. Besides effects of local toxicity (morphological alterations in the non-glandular stomach), ‘No toxicologically significant changes were noted in any of the remaining parameters’.

The corrected 8h inhalation NOAEC for general population is NOAEL (60 mg/kg) * 1.35 mg/m3 = 44.44 mg/m3. No factor 2 route extrapolation from oral to inhalation. Due to very low vp (estimated 3.96 x 10-5 Pa) exposures via vapour are not significant. Exposure is only possible as aerosol or larger particles as the use does not include fine spraying. Droplets will deposit mainly on upper airways and will be subsequently swallowed following mucocilliary 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 for systemic effects.
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:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Available data derived from valid study showing consistent results with several studies.
AF for remaining uncertainties:
1
Justification:
No uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.3 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:
60 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
60 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point: 90-day (OECD 408) repeated dose toxicity study with Coco amidopropyldimethylamine resulted to a NOAEL for systemic toxicity of 60 mg/kg bw. Besides effects of local toxicity (morphological alterations in the non-glandular stomach), ‘No toxicologically significant changes were noted in any of the remaining parameters’.

This substance is 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.

AF for dose response relationship:
1
Justification:
No specific concerns; starting point is NOAEL for systemic effects.
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:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Available data derived from valid study showing consistent results with several studies.
AF for remaining uncertainties:
1
Justification:
No uncertainties identified.
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.3 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:
60 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
60 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Not applicable

AF for dose response relationship:
1
Justification:
No specific concerns; starting point is NOAEL for systemic effects.
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:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Available data derived from valid study showing consistent results with several studies.
AF for remaining uncertainties:
1
Justification:
No uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected

Additional information - General Population

The uses indicated in this dossier are limited to industrial and professional users and exposure of the general population to Coco amidopropyldimethylamine 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.