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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
10 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
25
Dose descriptor starting point:
NOAEC
Value:
500 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
251 mg/m³
Explanation for the modification of the dose descriptor starting point:
No route extrapolation required. 251 mg/m³ represents the corrected worker NOAEC, derived according Guidance R8 from the NOAEC of 500 mg/m³ observed in a subchronic rat inhalation study
AF for dose response relationship:
1
Justification:
ECHA Guidance R8
AF for differences in duration of exposure:
2
Justification:
ECHA Guidance R8; Table R.8-6
AF for interspecies differences (allometric scaling):
1
Justification:
no allometric scaling required; cf. ECHA Guidance R8
AF for other interspecies differences:
2.5
Justification:
ECHA Guidance R8; Table R.8-6
AF for intraspecies differences:
5
Justification:
ECHA Guidance R8; Table R.8-6
AF for the quality of the whole database:
1
Justification:
no systemic effects at the top dose in a subchronic GLP guideline study
AF for remaining uncertainties:
1
Justification:
no further uncertainties (absorption, metabolism etc.) identified
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
12 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: Permissible OEL value 5 ppm
Acute/short term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
24 mg/m³
Most sensitive endpoint:
irritation (respiratory tract)
DNEL related information
DNEL derivation method:
other: permissible short-term OEL

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.9 mg/kg bw/day
Most sensitive endpoint:
skin irritation/corrosion
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Dose descriptor starting point:
NOAEC
Value:
500 mg/m³
Modified dose descriptor starting point:
NOAEL
Value:
190 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Starting point: NOAEC (90d inh., rat) = 500 mg/m3 for systemic effects: corresponding to a dose in rat of NOAEC(inhal.) x0.38 m3/kg bw/d = 190 mg/kg bw/d

AF for dose response relationship:
1
Justification:
default value
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic extrapolation
AF for interspecies differences (allometric scaling):
4
Justification:
default value for rats
AF for other interspecies differences:
2.5
Justification:
default value
AF for intraspecies differences:
5
Justification:
default value for workers
AF for the quality of the whole database:
1
Justification:
qualified database
AF for remaining uncertainties:
1
Justification:
default value
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
high hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

Isopropylamine is assumed to be readily bioavailable by all routes of exposure. Exposure may mainly occur by inhalation

and by skin contact. Based on general experience and knowledge with this class of substances, isopropylamine is readily eliminated from the organism either metabolised by oxidative desamination, thus resulting in acetone, or excreted from the body in unchanged form. Overall, isopropylamine will not accumulate and is not expected to form harmful intermediates (Beard and Noe 1981; Cavender et al. 2000).

The primary and most relevant effect is the local irritating/corrosive effect on skin and mucous membranes. This severe local insult limits the exposure levels in animal studies. No significant systemic and reproduction toxicity was observed in rats after inhalation of concentrations as high as 500 mg/m3 (90 -day study) and 1000 mg/m3 (reproduction toxicity study). The available data tabulated below indicate that the DNEL has to be established below 10 ppm (25 mg/m3), as 10 ppm is reported to be an irritating exposure level for affected workers. Furthermore, this value is in a range where no sensory irritation was seen in mice (see Table below). Corresponding DNELs for potential systemic intoxication would be expected to be greater than those for local effects.

Overview of effects data following exposure to isopropylamine

Olfactory / nasal effects markers

Exposure concentrations

Reference

Section IUCLID5

mL/m3

mg/m3

Odor threshold (human)

1.2

~3

Amoore and Hautala 1983

7.10.3

Nasal irritation threshold (human)

10

25

Beard and Noe 1981

7.10.3

RD50 (mouse, 15 min) *)

157

390

Gagnaire et al. 1989, 1993

7.2.2

Estimate from RD50:
RD0 (mouse, 15 min) *)

~15

~37

NOAEC (systemic effects, rat, 90 d)

215

500

Monsanto 1988

7.5.3

NOAEC (histopathological changes, rat, 28d)

43

100

Dudek et al. 1991

7.5.3

However, the systemic DNELs above have been derived according to ECHA from the subchronic rat inhalation study where no systemic toxicity was observed at the highest tested concentration (NOAEC 500 mg/m³). This results in 10 mg/m³ for the long-term systemic worker DNEL and 20 mg/m³ for the short-term DNEL.

Another approach was used for the derivation of a permissible OEL value of 5 ppm (12 mg/m³), based on the local effects reportedly observed in the respiratory tract of humans exposed to 10 to 20 ppm (Beard and Noe, 1981; cf. table). The study was not located and there are only secondary sources, but this value was, inter alia, considered by the following committees:

NIOSH (1978) Occupational Health Guideline for isopropylamine;

MAK-justification (2000; 2002);

Health Council of the Netherlands (2004) Committee on Updating of Occupational Exposure Limits. Isopropylamine; Health-based Reassessment of Administrative Occupational Exposure Limits. The Hague: Health Council of the Netherlands

It should be noted that the MAK-value was set at 5 ppm as early as in 1958. It was reassessed several times but there was no study result or medical finding that justified lowering the OEL value. Today, the OEL of 5 ppm (10 ppm short-term) has been adopted by many countries worldwide (GESTIS; https://limitvalue.ifa.dguv.de/WebForm_ueliste2.aspx; accessed 2020 -02 -24; table below and also attached document in Section 13):

Substance Isopropylamine CAS No. 75-31-0

Limit value - Eight hours Limit value - Short term

ppm / mg/m³ / ppm / mg/m³

--------------------------------------------------------------------------------------------------------------------------

Australia 5 / 12 / 10 / 24

Austria 5 / 12 / 20 /48

Belgium 5 / 12 / 10 (1) / 24 (1)

Canada - Ontario 5 / - / 10 / -

Canada - Québec 5 / 12 / 10 / 24

Denmark 5 / 12 / 10 / 24

Finland - / - / 5 (1) / 12 (1)

France 5 / 12 / - / -

Germany (AGS) 5 / 12 / 10 (1) / 24 (1)

Germany (DFG) 5 / 12 / 10 (1)(2) / 24

Ireland 5 / 12 10 (1) 24 (1)

New Zealand 5 12 10 24

People's Republic of China - / 12 / - / 24 (1)

Romania 3 / 7 / 4 (1) / 10 (1)

Singapore 5 / 12 / 10 / 24

South Korea 5 / 12 / 10 / 24

Spain 5 / 12 / 10 / 24

Sweden 5 / 12 / 10 (1) / 25 (1)

Switzerland 5 / 12 / 10 / 24

USA - OSHA 5 / 12 / - / -

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Remarks

Belgium (1) 15 minutes average value

Finland (1) 15 minutes average value

Germany (AGS) (1) Ceiling limit value

Germany (DFG) (1) 15 minutes average value (2) A momentary value of 10 ml/m³ (25 mg/m³) should not be exceeded.

Ireland (1) 15 minutes reference period

People's Republic of China (1) 15 minutes average value

Romania (1) 15 minutes average value

Sweden (1) 15 minutes average value

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
no hazard identified
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

The general public is no target population. As the substance is not classified as carcinogenic, mutagenic or reproductive toxicant nor for specific target organ toxicity single exposure (STOT SE) Cat. 1 assessment for human exposure via environment has to be performed and no corresponding DNELs have to be derived.