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EC number: 200-860-9 | CAS number: 75-31-0
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
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: |
~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 / - / -
-------------------------------------------------------------------------------------------------------------
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.
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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