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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 203-558-5 | CAS number: 108-18-9
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- other: Health Council of the Netherlands (2003)
- Overall assessment factor (AF):
- 27
- Modified dose descriptor starting point:
- LOAEC
- AF for dose response relationship:
- 3
- AF for other interspecies differences:
- 3
- AF for intraspecies differences:
- 3
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 18 mg/m³
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: Health Council of the Netherlands
- Overall assessment factor (AF):
- 27
- Dose descriptor:
- LOAEC
- AF for dose response relationship:
- 3
- AF for other interspecies differences:
- 3
- AF for intraspecies differences:
- 3
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 18 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 125
- Dose descriptor starting point:
- LOAEC
- AF for dose response relationship:
- 10
- Justification:
- Default AF considering that Diisopropylamine induced histological changes in the nasal passages of mice at concentrations of 257 mg/m3 and higher after a 4-day exposure (6 hours per day, 5 days per week) (Zissu, 1995)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not needed
- AF for other interspecies differences:
- 2.5
- Justification:
- Default AF
- AF for intraspecies differences:
- 5
- Justification:
- Default AF
- AF for the quality of the whole database:
- 1
- Justification:
- Not needed
- AF for remaining uncertainties:
- 1
- Justification:
- Not needed
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Dermal
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 300
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Not needed
- AF for differences in duration of exposure:
- 6
- Justification:
- Default AF
- AF for interspecies differences (allometric scaling):
- 2.5
- Justification:
- Default AF
- AF for other interspecies differences:
- 4
- Justification:
- Default AF
- AF for intraspecies differences:
- 5
- Justification:
- Default AF
- AF for the quality of the whole database:
- 1
- Justification:
- Not needed
- AF for remaining uncertainties:
- 1
- Justification:
- Not needed
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.22 mg/cm²
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- other: NOAEL
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 2
- Justification:
- There was no evidence of skin irritation in rats treated with doses up to 150 mg/kg bw/day Diisopropylamine for 1 week or 1 month (Naylor, 1987), indicating that the irritating effect is more dose-related than duration-related. Therefore, an AF of 2 will be used to extrapolate for a subacute to a chronic exposure duration.
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - workers
Occupational exposure limits (8 -h time weighted average) of 5 ppm have been adopted in different European countries (Austria, Belgium, Germany, Great Britain, France, Sweden and Denmark) and in USA (ACGIH, OSHA, NIOSH).
Substance |
Diisopropylamine |
CAS No. |
108-18-9 |
Limit value - Eight hours |
Limit value - Short term |
|
ppm |
mg/m³ |
ppm |
mg/m³ |
Austria |
5 |
20 |
10 |
40 |
Belgium |
5 |
21 |
|
|
Canada - Québec |
5 |
21 |
|
|
Denmark |
5 |
20 |
10 |
40 |
European Union |
|
|
|
|
France |
5 |
20 |
|
|
Germany (AGS) |
|
|
|
|
Germany (DFG) |
|
|
|
|
Hungary |
|
|
|
|
Italy |
|
|
|
|
Japan |
|
|
|
|
Poland |
|
|
|
|
Spain |
5 |
21 |
|
|
Sweden |
5 |
20 |
10 |
40 |
Switzerland |
5 |
20 |
|
|
The Netherlands |
|
|
|
|
USA - NIOSH |
5 |
20 |
|
|
USA - OSHA |
5 |
20 |
|
|
United Kingdom |
5 |
21 |
|
|
|
Remarks |
Spain |
skin |
However, a recent review was performed by the Committee on Updating of Occupational Exposure Limits, a committee of the Health Council of the Netherlands (Health-based Reassessment of Administrative Occupational Exposure Limits, Diisopropylamine (CAS No: 108-18-9). No. 2000/15OSH/080, The Hague, 22 October 2003). The committee takes the LOAEL of 100 mg/m3for both systemic toxicity and local irritation found in the 1-month inhalation study in rats (Val Roloff, 1987) as a starting point in deriving a health-based recommended occupational exposure limit (HBROEL). For the extrapolation to a HBROEL, an overall assessment factor of 27 was used. This factor covers the following aspects: the absence of a NOAEL and intra- and interspecies variations. Thus, applying this factor and the preferred value approach, a health-based occupational exposure limit of 5 mg/m3(1.2 ppm) was recommended for diisopropylamine. The committee recommended a health-based occupational exposure limit for diisopropylamine of 5 mg/m3(1.2 ppm), as an 8-hour time-weighted average (TWA).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.6 mg/m³
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
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:
- DNEL (Derived No Effect Level)
- Value:
- 0.6 mg/m³
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:
- 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
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:
- 83 µg/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):
- 600
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 50 mg/kg bw/day
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- AF for interspecies differences (allometric scaling):
- 4
- AF for other interspecies differences:
- 2.5
- AF for intraspecies differences:
- 10
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
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:
- medium hazard (no threshold derived)
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
