Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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: 203-462-3 | CAS number: 107-10-8
- 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
Acute/short term exposure
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.91 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 9.82 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
According to Annex VI of Directive 67/548/EEC propylamine is classified/labelled as harmful by inhalation, in contact with skin and if swallowed (R20/21/22) as well as corrosive (R34). The primary routes of industrial exposure to propylamine are via inhalation and skin contact.
Upon treatment of rabbit skin with propylamine for 24 hours under not further specified conditions all treated sites were thick and erythematous. In 3/6 animals surface dermatolysis was present which became dry, hard and concave, being characteristic of dry necrosis (Pennwalt 1977). To control risks of local dermal irritation a qualitative exposure assessment was performed. Though suitable for hazard assessment, the available experimental data do not allow for a quantitative risk assessment. Therefore, following the recommendations of Part E (Risk characterization) and Chapter R.13 (Risk Management Measures and Operational Conditions) of the REACh Guidance on Information Requirements and Chemical Safety Assessment, a qualitative risk assessment was performed for the dermal route. Based on its moderate corrosive properties, propylamine was allocated to the moderate hazard category. Appropriate risk management measures for the moderate hazard category given in Table E.3-1, Part E (Risk Characterisation) of the REACh Guidance on Information Requirements and Chemical Safety Assessment, were applied.
Local inhalative effects were considered to be a further critical
endpoint for workers. However, no reliable repeated dose toxicity study
with propylamine was available for DNEL derivation. Therefore, a
read-across to other structural analogue primary alkylamines including
ethylamine (CAS No. 75-04-7), butylamine (CAS No 109-73-9) and
isopropylamine (CAS 75-31-0) was done.
In a repeated dose inhalation toxicity study, rats were exposed to
ethylamine at doses of 10, 100 and 500 ppm (18, 184, 922 mg/m3) for 24
weeks (6h/d, 5d/week). The NOAEC for local effects was 100 ppm and the
LOAEC was set at 500 ppm (Lynch, 1988). To derive a long-term inhalative
DNEL the observed no effect level was modified according to guidance
document R. 8 (ECHA, May 2008). An overall assessment factor (AF) of 10
(interspecies: 5; exposure duration: 2 [sub-chronic to chronic];
dose-response: 1; quality of whole database: 1) was applied and the
derived inhalative long-term DNEL for ethylamine was 18.4 mg/m³ (10 ppm)
for the worker.
The German authority (MAK-Commission) established a comparable OEL (5 ppm) which was also based on the study of Lynch (1988) as well as further reports. A TLV of 10 ppm (TWA) determined by the American Conference of Governmental Industrial Hygienists confirmed the reliability of the estimated long-term DNEL of 10 ppm for propylamine.
In a one generation repeated dose reproductive toxicity study, rats were exposed for 6h/day on 5d/week to 20, 100 and 500 mg/m3 to isopropylamine for 12-13 and 14-15 weeks (males and females), respectively (Monsanto 1988). No effects on mating or fertility parameters were seen at the highest dose of 500 mg/m3. On examination of the offspring no treatment related effects were seen. With regard to reproductive toxicity the NOAEL was 500 mg/m3. However, 2 males of the high dose group died. In addition, males of the high dose group had a significantly lower body weight during the majority of the study. With regard to parental toxicity 500 mg/m3 was assessed as LOAEL. The NOAEL was set at 100 mg/m3.
Applying the AF used for ethylamine (see above) the long-term DNEL for isopropylamine was 10 mg/m3 (4 ppm). The German MAK-Commission, however established an OEL of 5 ppm based on studies of Monsanto (1988) as well as further reports. The American Conference of Governmental Industrial Hygienists determined a TLV of 10 ppm (TWA) for isopropylamine.
In a prenatal developmental toxicity study, rats were exposed for 14 days (6h/day) to 51, 151 and 460 mg/m3 butylamine (BASF AG 96/192, 2001). On histopathology, changes of the respiratory epithelium in the nasal cavity, like infiltration of inflammatory cells and/or (multi) focal squamous cell metaplasia were seen in all dose groups. Focal necrosis of the nasal mucosa was only seen at the highest dose group. With regard to maternal toxicity the lowest dose group of 51 mg/m3 (17 ppm) was established as LOAEC. Since no effects on gestational parameters and no signs of prenatal developmental toxicity were seen, the highest dose (460 mg/m3) was established as NOAEC with regard to developmental toxicity.
In general, the German authority sets occupational exposure limits of aliphatic amines depending on their irritating properties on the respiratory tract. The breathing frequency of mice, oronasally exposed to 20 different amines for 15 minutes, was assessed by Gagnaire (1989). OELs for amines with a RD50 below 100 ppm are generally set at 2 ppm by the MAK-Commission. The RD50 of butylamine of 112 ppm would apply to an OEL of 5 ppm. Taking into account the strong irritating effects seen in the study of BASF AG (96/192, 2001), the MAK-Comission established an OEL of 2 ppm for butylamine.
In agreement, the American Conference of Governmental Industrial Hygienists determined a TLV of 5 ppm (ceiling limit) for butylamine.
Overall, the German MAK-Commission determined OEL values of 5, 2 and 5 ppm for ethylamine, butylamine and isopropylamine, respectively. In addition, the American Conference of Governmental Industrial Hygienists determined TLVs of 10, 5 and 5 ppm (TWA) for the respective amines. OELs and TLVs were based on local irritation effects on the respiratory tract. Due to the high consensus of the available OELs and TLVs and the high grade of structure analogy between the substances, a local long-term DNEL for propylamine was established at 2 ppm (= 4.91 mg/m3).
The German MAK-Commission established excursion factors of 2 for ethylamine (CAS No. 75-04-7), butylamine (CAS No 109-73-9) and isopropylamine (CAS 75-31-0), respectively. The short term DNEL was therefore calculated as 9.82 mg/m³. The Risk Management Measures and Operational Conditions corresponded to those used in the respective long-term scenario.
General Population - Hazard via inhalation route
Systemic effects
Acute/short term exposure
DNEL related information
Local effects
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
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Since propylamine is used at industrial and professional domains only, no exposure of the general population to propylamine is expected. Therefore no DNELs for the general population were calculated.
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.