Registration Dossier

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
DNEL 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
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
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Acute/short term exposure
DNEL related information

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
DNEL 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
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population