Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
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EC number: - | CAS number: -
Toxicological Summary
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
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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