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Diss Factsheets
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EC number: 203-916-0 | CAS number: 111-86-4
- 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:
- 4.6 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 137.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- only reliable guideline study with repeated exposure available
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 6
- Justification:
- default value (subacute to chronic)
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not necessary, scaling factor 4 used for calculation of inhalation concentration from oral NOAEL
- AF for other interspecies differences:
- 1
- Justification:
- not necessary for inhalation concentration
- AF for intraspecies differences:
- 5
- Justification:
- default value
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 1
- Justification:
- default value (no remaining uncertainties)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 26.85 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: adoption of the work place limit value of structurally related amines
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 53.7 mg/m³
- Most sensitive endpoint:
- irritation (respiratory tract)
DNEL related information
- DNEL derivation method:
- other: adoption of the work place limit value of structurally related amines
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.65 mg/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):
- 120
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 78 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- only reliable guideline study with repeated exposure available
- AF for dose response relationship:
- 1
- Justification:
- default value
- AF for differences in duration of exposure:
- 6
- Justification:
- default value (subacute to chronic)
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- default value (allometric scaling rat)
- AF for other interspecies differences:
- 1
- AF for intraspecies differences:
- 5
- Justification:
- default value
- AF for the quality of the whole database:
- 1
- Justification:
- default value
- AF for remaining uncertainties:
- 1
- Justification:
- default value (no uncertainties)
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:
- high hazard (no threshold derived)
Additional information - workers
N-octylamine is acutely toxic upon all resorption routes. Regarding toxicokinetics, n-octylamine is metabolised via oxidative deamination by MAO (monoamine oxidase) to NH3and octanal which is further metabolised via aldehyde dehydrogenase and subsequently ß-oxidation. There is no potential for bioaccumulation of n-octylamine.
The acute oral LD50in rats is approx. 315 mg/kg bw, the dermal LD50 was between 200 and 2000 mg/kg bw, and the inhalation LC50 (rat, 4 hours) was 1.6 mg/L. N-octylamine is corrosive to the skin and eyes, and irritating to the respiratory tract. The latter is due to the alkalinity of the free base, which is a common feature of all primary alkylamines, all having an unshared electron pair. Due to corrosivity and for reasons of animal welfare, the possibilities to conduct repeated dose studies are very limited. Therefore, the systemic toxicity of n-octylamine was examined in a combined OECD TG 422 oral rat study using the hydrochloride salt. The NOAEL was 100 mg/kg bw/day for male and female systemic toxicity, and for reproduction and developmental toxicity in this study. N-octylamine lacked genotoxicity in bacterial and mammalian cells in vitro, no micronuclei were observed in vivo in mice after single oral exposure to n-octylamine hydrochloride.
The following DNELs were not derived using the procedure set out in the Guidance Document R8:
- DNELs for dermal exposure, since no sufficient data are available for this; moreover, skin contact should be avoided due to irritation and local cytotoxic effects on the skin and the high systemic toxicity after dermal exposure.
- DNELs for local or systemic effects upon inhalation since there is not sufficient data in order to assess this.
- DNELs for the general population since there is no designed exposure of the general public to this material.
For acute inhalation exposure at the work place a DNEL of 10 ppm [53.7 mg/m3(short term value; local effects)] is proposed, which is twice of the proposed long term Limit Value- Eight hours (5 ppm; 26.85 mg/m³). These proposals are based on the following assumptions
- the local effects prevail over systemic effects;
- local effects depend on alkalinity, and are therefore comparable between short and medium size alkylamines in the range C1 to C13;
- existing Limit Values (as ppm) can therefore directly be read across between alkylamines;
- most alkylamines have a Limit Value-Eight hours of 5 ppm
- the short term value (15 minutes) factor is 2, based on the dominance of corrosive effects;
- for several alkylamines, Limit Values exist since many years worldwide and have proven to warrant safe conditions;
- re-assessment of Limit Values have been conducted by authorities in several countries
- bad odour and immediate recognition of skin, eye, or throat irritation provide warnings (thus limiting exposure duration) if the Limit Value would be exceeded
For chronic inhalation exposure, a DNEL of 5 ppm (26.85 mg/m³) could be proposed, according to the rational given above. This would protect against local skin, eye, and respiratory effects, and also against systemic effects. The uptake would be up to 268.5 mg/person within an 8-hour work shift, or 2.74 mg/kg bw/day (7 days/week).
Alternatively, a chronic DNEL could be derived from the results obtained in the subchronic rat study mentioned above. The NOAEL was 100 mg octylamine-hydrochloride/kg bw/day, the highest tested dose. Conversion of the oral NOAEL to the inhalation route, and combination with an overall assessment factor of 30 (5 for intraspecies differences; 6 for extrapolation subacute > chronic), and correction for the molecular weight difference would result in a DNEL of 0.854 ppm (4.58 mg octylamine/m³). This would be only approx. 1/6 of the DNEL of 5 ppm which was suggested based on occupational exposure experience with alkylamines, thus suggesting overprotection against systemic effects. This approach is considered to be very conservative as in the oral study underlying this R2R extrapolation no adverse effects were observed up to the highest concentration tested.
Also, a DNEL for systemic effects after dermal exposure can be derived: Starting point: NOAEL (28d oral, rat, 1-octylamine hydrochloride) = 100 mg/kg bw for systemic effects = 78 mg/kg 1-octylamine, factors according to guidance R.8 for adjustment to chronic exposure (6), workers (5) and allometric scaling for Rat (4). 6*5*4=120.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- hazard unknown (no further information necessary)
Additional information - General Population
DNELs not derived because not considered to be relevant: the general public is no target 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.
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