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EC number: 203-972-6 | CAS number: 112-44-7
- 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:
- 23.5 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 763 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL of 1000 mg/kg bw and day (rat, oral, subacute) may be used to calculate, according to the guidance document R8, a corrected inhalation NOAEC of 1763 mg/m³ for workers.
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not applicable for inhalative DNEL
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- Justification:
- database sufficient for assessment
- AF for remaining uncertainties:
- 1
- Justification:
- no assessment factor for route-to-route extrapolation was applied as 100% bioavailability is assumed for both routes
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- other: generic cut-off limit for skin irritating substances
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- other: generic cut-off limit for skin irritating substances
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3.3 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- In accordance with guidance R.8 no default factor is used for oral-to-dermal extrapolation as in general dermal absorption will not be higher than oral absorption.
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- Subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for remaining differences.
- AF for intraspecies differences:
- 5
- Justification:
- worker
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 1
- Justification:
- no assessment factor for route-to-route extrapolation was applied as dermal bioavailability usually is not higher than oral bioavailability
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Toxicology profile
N-undecanal (CAS 112-44-7) is a long chain, saturated straight chain aliphatic aldehyde. Water solubility and vapour pressure are both low. The substance may be rapidly absorbed following oral intake or inhalation exposure. The inhalation exposure is not considered to represent a relevant exposure pathway, based on the low vapour pressure, and based on the results of recent indoor air monitoring measurements (n ~ 3000) conducted in Germany during 2002-2006. The mean undecanal concentration was 3 µg/m³, calculated for those samples where the substance was found. Following absorption, undecanal is expected to be predominantly oxidised to undecanoic acid, a linear, saturated fatty acid which is expected to be degraded and utilized via fatty acid oxidation and intermediary metabolism. However, undecanoic acid and derivatives may also appear in the urine.
The acute toxicity was found to be low in rats (oral LD50>5000 mg/kg bw) and rabbits (dermal LD50>5000 mg/kg bw). Undecanal was irritating to the rabbit’s skin (at a level that requires classification), whereas eye irritation was mild and did not gain a level that requires classification. The substance showed no skin sensitising properties in humans who underwent a maximisation test.
Undecanal (100, 300, 1000 mg/kg bw and day) was tested in a combined OECD TG 422 study for repeated dose/reproduction toxicity in male and female rats (10 rats/sex and dose). There was no systemic toxicity up to and including the top dose, whereas local irritation was seen in the stomachs of animals from all dose levels. Likewise, there were no adverse effects on fertility and development noted. Therefore, the NOAEL was 1000 mg/kg bw and day for systemic toxicity, toxicity to reproduction and development under the conditions of this study.
Regarding genetic toxicity, undecanal was not mutagenic in bacterial (Salmonella typhimurium) or mammalian cells (HGPRT assay) in vitro. Undecanal was not clastogenic in-vitro (human leucocytes). All assays were conducted with and without metabolic activation.
Overall, undecanal is of low acute and subacute toxicity and no target tissue was identified.
DNELs may be derived from the NOAEL (rat, oral, subacute) of 1000 mg/kg bw and day. Undecanal is irritating to skin (Skin Irrit. 2).
DNEL derivation
Long term exposure, systemic effects: Inhalation: The NOAEL of 1000 mg/kg bw and day (rat, oral, subacute) may be used to calculate a corrected inhalation NOAEC of 1763 mg/m³ for workers ccording to guidance document R8. Assessment factors for intraspecies differences (5; workers), remaining interspecies differences (2.5) and for the duration of treatment (subacute > chronic; 6) may be used and result in a DNEL of 23.5 mg/m³.
Dermal: The NOAEL of 1000 mg/kg bw and day (rat, oral, subacute) may be used to calculate a DNEL of 3.3 mg/kg bw and day, using an overall assessment factor of 300 (allometric factor = 4; remaining interspecies differences = 2.5; intraspecies differences = 5; duration of experiment (subacute > chronic =6)).
No assessment factor for route-to-route extrapolation was applied as 100% bioavailability is assumed for inhalation and oral exposure; additionally, dermal bioavailability is usually not higher than oral bioavailability
There are no inhalation studies available for undecanal and no information exists if the substance causes local effects in the respiratory tract after inahalation exposure. As undecanal is not hydrolytically unstable and does not form strong acids or bases nor is a strong acid that vigorously reacts with water (exclusion criteria) the generic cut-off limit of 10 mg/m3for skin irritating subsances as suggested by Messinger (Regulatory Toxicology and Pharmacology 2014, 68: 317 -324) is applicable and suggested as DNEL for local effects after long-term inhalation exposure. In accordance with the procedure described by the German MAK Commission (Senate Commission for the Investigation of Health Hazards of Chemical Compounds in the Work Area), applying an exceedance factor 1 for substances with local effects and in a conservative manner in the absence of data the same DNEL is derived for local effects after long-term and acute exposure.
The following DNELS were not derived:
- DNELs for systemic effects following short-term dermal exposure, as the substance is not classified for acute toxicity
- DNELs for acute systemic effects following inhalative exposure since the substance is not classified for acute toxicity.
- DNEL for local dermal effects could not be derived from the available data, therefore a qualitative assessment as described in guidance on information requirements – part E has been conducted (leading to an allocation to the “low hazard band” for skin irritation)
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5.8 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- other: NOAEL
- Value:
- 870 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The NOAEL of 1000 mg/kg bw and day (rat, oral, subacute) may be used to calculate a corrected inhalation NOAEC of 870 mg/m³ for the general population according to the guidance document R.8.
.
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not applicable for inhalative DNEL
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- default value for consumer
- AF for the quality of the whole database:
- 1
- Justification:
- database sufficient for assessment
- AF for remaining uncertainties:
- 1
- Justification:
- no assessment factor for route-to-route extrapolation was applied as 100% bioavailability is assumed for both routes
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/m³
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- other: generic cut-off limit for skin irritating substances
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/m³
- Most sensitive endpoint:
- skin irritation/corrosion
DNEL related information
- DNEL derivation method:
- other: generic cut-off limit for skin irritating substances
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
In accordance with guidance R.8 no default factor is used for oral-to-dermal extrapolation as in general dermal absorption will not be higher than oral absorption.
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- sufficiently qualified database
- AF for remaining uncertainties:
- 1
- Justification:
- no assessment factor for route-to-route extrapolation was applied as dermal bioavailability usually is not higher than oral bioavailability
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
- Most sensitive endpoint:
- skin irritation/corrosion
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.7 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No modification required as an oral study is available.
- AF for dose response relationship:
- 1
- Justification:
- Starting point NOAEL
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default value for remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- sufficiently qualified database
- AF for remaining uncertainties:
- 1
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
- Most sensitive endpoint:
- acute toxicity
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
DNELs may be derived from the NOAEL (rat, oral, subacute) of 1000 mg/kg bw and day. Undecanal is irritating to skin (Skin Irrit. 2).
DNEL derivation
Long term exposure, systemic effects:
Inhalation: The NOAEL of 1000 mg/kg bw and day (rat, oral, subacute) may be used to calculate, according to guidance document R8, a corrected inhalation NOAEC of 870 mg/m³ for workers. Assessment factors for
intraspecies differences (10; general population), remaining interspecies differences (2.5) and for the duration of treatment (subacute > chronic; 6) may be used and result in a DNEL of 5.8 mg/m³.
Dermal and oral: The NOAEL of 1000 mg/kg bw and day (rat, oral, subacute) may be used to calculate a DNEL of 1.7
mg/kg bw and day, using an overall assessment factor of 600 (allometric factor = 4; remaining interspecies differences = 2.5; intraspecies differences = 10; duration of experiment (subacute > chronic =6)).
No assessment factor for route-to-route extrapolation was applied as 100% bioavailability is assumed for inhalation and oral exposure; additionally, dermal bioavailability is usually not higher than oral bioavailability.
There are no inhalation studies available for undecanal and no information exists if the substance causes local effects in the respiratory tract after inahalation exposure. As undecanal is not hydrolytically unstable and does not form strong acids or bases nor is a strong acid that vigorously reacts with water (exclusion criteria) based on the the generic cut-off limit for workers of 10 mg/m3 for skin irritating substances as suggested by Messinger (Regulatory Toxicology and Pharmacology 2014, 68: 317 -324) a DNEL of 5 mg/m3 for local effects after long-term inhalation exposure is suggested for the general population assuming a twofold higher factor for intraspecies variability.
In a conservative manner in the absence of data the same DNEL value has been derived for local effects after long-term and acute exposure.
The following DNELS were not derived:
- DNELs for systemic acute effects after inhalation, dermal and oral exposure, as the substance is not classified for acute toxicity.
- DNEL for local dermal effects could not be derived from the available data, therefore a qualitative assessment as described in guidance on information requirements – part E will be conducted in the CSR (allocation of “low hazard band” for skin irritation)
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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