Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.07 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Draft RAR for Primary Alklylamines, 2008, by European Commission (Rapporteur Germany)
Overall assessment factor (AF):
37.5
Dose descriptor starting point:
NOAEL
Value:
3.25 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
40.11 mg/m³
Explanation for the modification of the dose descriptor starting point:

Inhalation DNEL assessment is based on the oral NOAEL for rats of 3.25 mg /kg/day. Dose modifiers: bioavailability (10% inhalation x 50% oral) = 5; others are per ECHA/DNEL calculator. The resulting modified dose descriptor is 40.11 mg/m3.

AF for dose response relationship:
1
Justification:
per Draft RAR, 2008
AF for differences in duration of exposure:
3
Justification:
per Draft RAR, 2008. This is based on lack of more extreme manifestations of toxicity in long term (lifetime) studies compared to short term studies.
AF for interspecies differences (allometric scaling):
4
Justification:
per Draft RAR, 2008
AF for other interspecies differences:
2.5
Justification:
per Draft RAR, 2008
AF for intraspecies differences:
5
Justification:
per Draft RAR, 2008
AF for the quality of the whole database:
1
AF for remaining uncertainties:
1
Justification:
per Draft RAR, 2008 on category substances
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:
0.15 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Draft RAR for Primary Alklylamines, 2008, by European Commission (Rapporteur Germany)
Overall assessment factor (AF):
150
Dose descriptor starting point:
NOAEL
Value:
3.25 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
22.75 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Dermal DNEL assessment is based on the oral NOAEL for rats of 3.25 mg /kg/day for Primary alkylamines, EU RAR, 2008. A dose modifier of 5 for bioavailability (dermal absorption (10%) x oral absorption of (50%)) and 1.4 for time adjustment (5 days/week (worker) vs. 7 days/week (experimental)).

AF for dose response relationship:
1
Justification:
per EU RAR, 2008
AF for differences in duration of exposure:
3
Justification:
per EU RAR, 2008
AF for interspecies differences (allometric scaling):
4
Justification:
per EU RAR, 2008
AF for other interspecies differences:
2.5
Justification:
per EU RAR, 2008
AF for intraspecies differences:
5
Justification:
per EU RAR, 2008
AF for the quality of the whole database:
1
Justification:
per EU RAR, 2008
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

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:
hazard unknown but no further hazard information necessary as no exposure expected
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:
hazard unknown but no further hazard information necessary as no exposure expected
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:
0.01 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: Draft RAR for Primary Alklylamines, 2008, by European Commission (Rapporteur Germany)
Overall assessment factor (AF):
300
Dose descriptor starting point:
NOAEL
Value:
3.25 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1.625 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

NOAEL is 3.25 mg/kg bw/d per EU RAR, 2008, on Primary Alkylamines. A dose modifier of 50% is applied for bioavailability (50%), making the final dose descriptor 1.625 mg/kg bw/d.

AF for dose response relationship:
1
Justification:
per EU RAR, 2008.
AF for differences in duration of exposure:
3
Justification:
per EU RAR, 2008
AF for interspecies differences (allometric scaling):
4
Justification:
per EU RAR, 2008
AF for other interspecies differences:
2.5
Justification:
per EU RAR, 2008
AF for intraspecies differences:
10
Justification:
per EU RAR, 2008
AF for the quality of the whole database:
1
Justification:
per EU RAR, 2008
AF for remaining uncertainties:
1
Justification:
per EU RAR, 2008
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