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EC number: 482-070-6 | CAS number: 1001354-72-8
- 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
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 29 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):
- 9
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No inhalation study available for the substance. NOAEC calcultated from NOAEL obtained in an oral study.
- AF for dose response relationship:
- 1
- Justification:
- there is a clear dose response and the effect drving the NOAEL is not severe
- AF for differences in duration of exposure:
- 3
- Justification:
- conversion from a subchronic study to a chronic study
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- Justification:
- there were no effects observed at the top dose level therefore there appears to be no justification for an additional factor of 2.5
- AF for intraspecies differences:
- 3
- Justification:
- based on the guidance by ECETOC and SCOEL on intra-worker variability
- AF for the quality of the whole database:
- 1
- Justification:
- all studies are new and to OECD guidelines (excluding the dermal repeat dose screen) thus the quality of the database is considered to be sufficient.
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.3 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):
- 36
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- A repeated dose toxicity study for the dermal route is not available
- AF for dose response relationship:
- 1
- Justification:
- there is a clear dose response and the effect drving the NOAEL is not severe
- AF for differences in duration of exposure:
- 3
- Justification:
- conversion from a subchronic study to a chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling rat to human
- AF for other interspecies differences:
- 1
- Justification:
- there were no effects observed at the top dose level therefore there appears to be no justification for an additional factor of 2.5
- AF for intraspecies differences:
- 3
- Justification:
- based on the guidance by ECETOC and SCOEL on intra-worker variability
- AF for the quality of the whole database:
- 1
- Justification:
- all studies are new and to OECD guidelines (excluding the dermal repeat dose screen) thus the quality of the database is considered to be sufficient.
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
Acute / Short term exposure - Systemic effects
It is not considered to be necessary to calculate acute dermal and inhalation DNELs for octanolamine.
Octanolamine has a low volatility and is not anticipated to be present in aerosols at significant concentrations during manufacture or use. Therefore it is very unlikely that a worker would receive an acute inhalation exposure. It is also corrosive and this will subsequently limit the possibility for a worker to receive an acute dermal exposure to this substance as part of the normal manufacturing and use processes due the need for personal protective equipment during handling. If an acute dermal exposure were to occur, the corrosivity would ensure that the worker was immediately aware of the exposure and result in the cleaning of the exposure site. This will significantly limit the degree of absorption and systemic exposure and thus the potential for systemic toxicity.
Once formulated into a metalworking fluid, octanolamine will be at a low concentration, further limiting the opportunity for an acute exposure in the work force.
Acute / Short term, Long term - local effects
Dermal
Octanolamine is corrosive. As such it must be handled by workers using sufficient protective equipment to prevent accidental skin contact. Therefore it is not considered necessary to calculate a DNEL for local effects following acute or chronic dermal exposure.
Inhalation
There are no inhalation toxicity data available for the calculation of an Inhalation DNEL for local effects. The corrosivity of this substance will likely mean that vapors would be irritating however the vapour pressure is low minimizing the potential for inhalation exposure to vapour. Risk management measures employed while handling the concentrated form will also limit the potential for inhalation exposure.
Long term Exposure - systemic effects
The long-term exposure DNELS for systemic effects (dermal and inhalation) were calculated as follows:
Dermal DNEL:
The NOAEL of 150 mg/kg bw/day from the 90 -day repeat dose oral study in the rat was taken as the starting point.
The corrected human dermal NOAEL = oral NOAEL(rat) * (Oral Rat Absorption / Dermal human absorption)
Based on the in vitro dermal penetration data, the higher absorption level of 50% associated with 0.5% 3 -amino-4 -octanol solution will be taken as the value for dermal penetration. This is considered to be more conservative since it appears that higher concentrations lead to a lower degree of dermal penetration.
Oral absorption in the rat is taken as 100% in the absence of evidence to the contrary.
Therefore the corrected NOAEL for human dermal absorption = 150* (100/50) = 300 mg/kg bw/day.
An Assessment Factor of 36 was applied. This is made up of the following factors as prescribed by the CSA/CSR guidance documents:
4 = Allometric scaling rat to human
1 = Remaining differences - there were no effects observed at the top dose level therefore there appears to be no justification for an additional factor of 2.5
3 = intra species (worker) based on the guidance by ECETOC and SCOEL on intra-worker variability
3 = conversion from a sub-chronic study to a chronic study
1 = Dose response - there is a clear dose response and the effect driving the NOAEL is not severe
1 = Quality of the database - all the studies are new and to OECD guidelines (excluding the dermal repeat dose screen) thus the quality of the database is considered to be sufficient.
Dermal DNEL = 300/36 = 8.3 mg/kg bw/day
Inhalation DNEL:
Although Octanolamine is not volatile and thus will not have a tendency to form vapors, when used as a metalworking fluid additive it is feasible that aerosols of metalworking fluid will be generated above the machines working the metal. If these machines are not enclosed it is possible that a worker could inhale the mists and subsequently be exposed to octanolamine. Therefore an Inhalation DNEL has been calculated as follows:
The same NOAEL of 150 mg/kg bw/day was used (see above)
The corrected human inhalation NOAEL was calculated as prescribed by the guidance. i.e.
Human corrected Inhalation NOAEL = rat oral NOAEL* (1/sRVrat)*(ABSoral rat/ABS human inhal)*(sRVhuman/wRV)
= 150*(1/0.38)*(100/100)*(6.7/10)
= 264.5 mg/m3
Note: The value for oral absorption was taken as 100%. This is justified in the toxicokinetic statement where it is argued that due to the low molecular weight and LogPow of 1.3, octanolamine is believed to be absorbed well from the gastrointestinal tract. The value used for human inhalation absorption was taken as 100% since it is also likely to be absorbed well through the respiratory epithelia.
Assessment factor of 9 applied:
It was derived according to the guidance as follows:
1 = remaining differences (justification as above)
3 = intra species (worker) (justification as above)
3 = conversion from a sub-chronic study to a chronic study.
1 = Dose response - there is a clear dose response and the effect driving the NOAEL is not severe
1 = Quality of the database - all the studies are new and to OECD guidelines (excluding the dermal repeat dose screen) thus the quality of the database is considered to be sufficient.
Inhalation DNEL = 264.5 / 9 = 29 mg/m3
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 14.69 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):
- 18
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 264.5 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- No inhalation study available for the substance. NOAEC calcultated from NOAEL obtained in an oral study.
- AF for dose response relationship:
- 1
- Justification:
- there is a clear dose response and the effect drving the NOAEL is not severe
- AF for differences in duration of exposure:
- 3
- Justification:
- conversion from a subchronic study to a chronic study
- AF for interspecies differences (allometric scaling):
- 1
- AF for other interspecies differences:
- 1
- Justification:
- there were no effects observed at the top dose level therefore there appears to be no justification for an additional factor of 2.5
- AF for intraspecies differences:
- 6
- Justification:
- based on the ECETOC report about variabilty within a population
- AF for the quality of the whole database:
- 1
- Justification:
- ll studies are new and to OECD guidelines (excluding the dermal repeat dose screen) thus the quality of the database is considered to be sufficient.
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 4.17 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 300 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- No dermal study available for the substance. NOAEL calculated from NOAEL obtained in an oral study.
- AF for dose response relationship:
- 1
- Justification:
- there is a clear dose response and the effect drving the NOAEL is not severe
- AF for differences in duration of exposure:
- 3
- Justification:
- conversion from a subchronic study to a chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling rat to human
- AF for other interspecies differences:
- 1
- Justification:
- there were no effects observed at the top dose level therefore there appears to be no justification for an additional factor of 2.5
- AF for intraspecies differences:
- 6
- Justification:
- based on the ECETOC report about variabilty within a population
- AF for the quality of the whole database:
- 1
- Justification:
- ll studies are new and to OECD guidelines (excluding the dermal repeat dose screen) thus the quality of the database is considered to be sufficient.
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- high hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.08 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: ECETOC
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 150 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- there is a clear dose response and the effect drving the NOAEL is not severe
- AF for differences in duration of exposure:
- 3
- Justification:
- conversion from a subchronic study to a chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling rat to human
- AF for other interspecies differences:
- 1
- Justification:
- there were no effects observed at the top dose level therefore there appears to be no justification for an additional factor of 2.5
- AF for intraspecies differences:
- 6
- Justification:
- based on the ECETOC report about variabilty within a population
- AF for the quality of the whole database:
- 1
- Justification:
- all studies are new and to OECD guidelines (excluding the dermal repeat dose screen) thus the quality of the database is considered to be sufficient.
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - General Population
The substance is used as an additive in metalworking fluid and paint and coatings, present at levels of approximately 0.1%. Due to the low amount of octanolamine in the metal working fluid and paints and coatings, it is not anticipated that there will be indirect consumer exposure via the handling of manufactured goods.
Indirect exposure via the environment:
Octanolamine is readily biodegradable and so once in the environment following discharge through waste water treatment facilities, it will degrade quickly, minimising/eliminating the potential for indirect exposure via the environment or food. It is not volatile and so it is highly unlikely that the general population could be exposed via the presence of vapours in the air.
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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