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EC number: 271-239-8 | CAS number: 68526-91-0 A complex combination of hydrocarbons produced by the distillation of products from the hydrogenation of isotridecanal from the hydroformylation of dodecene. It consists predominantly of C13-14 primary aliphatic alcohols, C22-28 dimer alcohols, C26 acetals and esters, and C>10 acid sodium salts and boils in the range of approximately 250°C to 450°C (482°F to 842°F).
- 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:
- 29.39 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 18
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.33 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 72
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
Workers - Hazard for the eyes
Additional information - workers
Acute, short-term, systemic effects:
Since Oxooel 13 is of low acute toxicity with the median lethal dose values (LD50) being significantly greater than 2000 mg/kg by oral and dermal routes the dermal and inhalation DNELs derived for long-term exposure are considered sufficiently protective of acute exposure.
Acute, short-term exposure - local effects:
A LLNA indicated that Oxooel 13 is a sensitizer. But there are no reliable data (i.e. dose-relationship) available for quantitative assessment. Therefore a qualitative assessment is assumed.
Long-term exposure – systemic effects:
In a 28-day subacute toxicity study in the rat, potentially treatment-related hematologic signs of systemic toxicity were observed in male animals of the high dose group (1000 mg/kg bw/day). Based on these findings the "no observed adverse effect level" (NOAEL) for the test article is assessed to 300 mg/kg bw/day. The DNELs for inhalation and dermal long-term exposure are derived from the no observed adverse effect level obtained from this oral repeated dose toxicity study with this test item. In general, the calculation of DNEL is based on the no observed adverse effect level which has to be modified. To correct the interspecies difference between rat and human the no observed adverse effect level has to be corrected as follows:
Corrected starting point for the inhalative route for workers: = NOAEL * (1/0.38 m³/kg bw) * 6.7 m³/10 m³ (0.38 m³/kg bw: default respiratory volume for the rat corresponding to the daily duration of human exposure). For workers a correction is needed for the difference between respiratory rates under standard conditions and under conditions of light activity. Thus, the corrected starting point for workers was 528.9 mg/m³/d for inhalation. Further AFs are listed, which have to be taken into account for the final DNEL calculation: remaining differences (1), intraspecies differences: worker (3), exposure duration: subacute to chronic (6). The DNEL for long-term inhalative exposure, systemic effects is therefore considered to be 29.39 mg/m³/d.
Corrected starting point for the dermal route for workers: = NOAEL/0.5* = 600 mg/kg bw/day (an AF of 0.5 was used to consider the difference in absorption properties of gastrointestinal tract and rat skin.) Subsequently, the following assessment factors are taken into account for the final DNEL calculation of systemic dermal effects: interspecies differences: human-rat (4), remaining differences (1), intraspecies differences: worker (3), exposure duration: subacute to chronic (6). The resulting DNEL for long-term dermal systemic effects of the test item was 8.33 mg/kg bw/d for workers.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 8.7 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 30
- Modified dose descriptor starting point:
- NOAEC
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- Overall assessment factor (AF):
- 120
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
DNEL related information
General Population - Hazard for the eyes
Additional information - General Population
Acute, short-term, systemic effects:
Since Oxooel 13 is of low acute toxicity with the median lethal dose values (LD50) being significantly greater than 2000 mg/kg by oral and dermal routes the dermal and inhalation DNELs derived for long-term exposure are considered sufficiently protective of acute exposure.
Acute, short-term exposure - local effects:
A LLNA indicated that Oxooel 13 is a sensitizer. But there are no reliable data (i.e. dose-relationship) available for quantitative assessment. Therefore a qualitative assessment is assumed.
Long-term exposure – systemic effects:
In a 28-day subacute toxicity study in the rat, potentially treatment-related hematologic signs of systemic toxicity were observed in male animals of the high dose group (1000 mg/kg bw/day). Based on these findings the "no observed adverse effect level" (NOAEL) for the test article is assessed to 300 mg/kg bw/day. The DNELs for inhalation and dermal long-term exposure are derived from the no observed adverse effect level obtained from this oral repeated dose toxicity study with this test item. In general, the calculation of DNEL is based on the no observed adverse effect level which has to be modified. To correct the interspecies difference between rat and human the no observed adverse effect level has to be corrected as follows:
Corrected starting point for the inhalative route for the general population: = NOAEC (inhalation) = NOAEL (oral) /1.15 m3/kg bw. Thus, the corrected starting point for the general population was 260.9 mg/m³/d for inhalation. Further AFs are listed, which have to be taken into account for the final DNEL calculation: remaining differences (1), intraspecies differences: general population (5), exposure duration: subacute to chronic (6).The DNEL for long-term inhalative exposure, systemic effects is therefore considered to be (260.9/30) 8.7 mg/m³/d.
Corrected starting point for the dermal route for the general population: = NOAEL/0.5* = 600 mg/kg bw/day (an AF of 0.5 was used to consider the difference in dermal absorption properties of gastrointestinal tract and rat skin.)Subsequently, the following assessment factors are taken into account for the final DNEL calculation of systemic dermal effects: interspecies differences: human-rat (4), remaining differences (1), intraspecies differences: general population (5), exposure duration: subacute to chronic (6).The resulting DNEL for long-term dermal systemic effects of the test item was 5 mg/kg bw/d for the general population.
DNEL derivation for the oral route for the general population: the following assessment factors are taken into account for the final DNEL calculation of systemic oral effects: interspecies differences: human-rat (4), remaining differences (1), intraspecies differences: general population (5), exposure duration: subacute to chronic (6).The resulting DNEL for long-term dermal systemic effects of the test item was 2.5 mg/kg bw/d for the general population.
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