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Diss Factsheets
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EC number: 218-871-2 | CAS number: 2269-22-9
- 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:
- 161 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 65.625
- Dose descriptor starting point:
- NOAEC
- Value:
- 10 600 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10 600 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Based on NOAEC from inhalation teratology study (Nelson 1989).
Exposure duration in this study is 7 hours/day. Therefore an additional factor of 7/8 is included to reflect the difference of exposure duration between the study and workers.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- NOAEC from subactute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not required
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- for worker, a default AF of 5 is to be used
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 0.875
- Justification:
- accounts for the difference in exposure duration
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low 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:
- 300 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on NOAEL from oral 2-Gen.Reproductive Toxicity Study 1500 mg/kg bw/d * 100/10 (correction for 10% dermal absorption versus 100 % oral) = 15000 mg/kg bw/d
- AF for dose response relationship:
- 1
- Justification:
- DNEL based on corrected NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL from chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rats were used in the study
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor for remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- for worker, a default AF of 5 is to be used.
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
As aluminium tri-sec-butylate hydrolyses immediately upon contact with water or moisture to aluminium hydroxide and sec-butanol, the toxicokinetic behaviour is determined by these decomposition products and their absorption, distribution metabolism and excretion. Thus, in the TK-assessment, the focus lies on sec-butanol and aluminium 3+ compounds. As bioavailability (absorption) of aluminium compounds is limited (typically less than 1%) but sec-butanol is well absorbed the effects of sec-butanol do determine DNEL and PNEC derivation.
Acute DNELs:
Worker: Production of aluminium tri-sec-butylate is in excess of 10 t/y. According to the REACH "Guidance on information requirements and chemical safety assessment, Part B: Hazard Assessment", above 10 t/y, the establishment of acute toxicity DNEL is unnecessary in most cases, as the DNEL based on repeated dose toxicity is normally sufficient to ensure that adverse effects do not occur. Thus, as long term DNELs are available for sec-butanol and sec-butanol is not classified for acute toxicity via any route of exposure, separate acute DNELs were not derived. Since there are only few and partially only conditionally convincing results concerning the irritant effect of 2-butanol in man and animal, any irritant effect is considered unlikely at this concentration.
Long-term DNELs:
There is no OEL value for sec-butanol or aluminium tri-sec-butylate at community level..
Hence, the systemic DNELs for long term inhalation and dermal exposure were based on the inhalation teratogenicity study and the 2-generation oral (drinking water application) reproductive toxicity study with sec-butanol. Considering the bioavailability of 2-butanol compared with aluminium compounds, both resulting from hyrolysis of aluminium tri-sec-butylate, this is considered a conservative approach.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 242 mg/m³
- Most sensitive endpoint:
- developmental toxicity / teratogenicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 43.75
- Dose descriptor starting point:
- NOAEC
- Value:
- 10 600 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 10 600 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Based on NOAEC from inhalation teratology study (Nelson 1989).
Exposure duration in this study is 7 hours/day. Therefore an additional factor of 7/24 is included to reflect the difference of exposure duration between the study and workers.
- AF for dose response relationship:
- 1
- AF for differences in duration of exposure:
- 6
- Justification:
- subacute study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not applicable for inhalation route
- AF for other interspecies differences:
- 2.5
- Justification:
- default factor
- AF for intraspecies differences:
- 10
- Justification:
- consumer exposure
- AF for the quality of the whole database:
- 1
- AF for remaining uncertainties:
- 0.29
- Justification:
- 7/24
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low 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:
- 150 mg/kg bw/day
- Most sensitive endpoint:
- effect on fertility
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 1 500 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 15 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Based on NOAEL from oral 2-Gen.Reproductive Toxicity Study 1500 mg/kg bw/d * 100/10 (correction for 10% dermal absorption versus 100 % oral) = 15000 mg/kg bw/d
- AF for dose response relationship:
- 1
- Justification:
- based on modified NOAEL
- AF for differences in duration of exposure:
- 1
- Justification:
- based on chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- study in rat
- AF for other interspecies differences:
- 2.5
- Justification:
- default
- AF for intraspecies differences:
- 10
- Justification:
- consumer exposure
- AF for the quality of the whole database:
- 1
- Justification:
- not required
- AF for remaining uncertainties:
- 1
- Justification:
- not required
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
- Modified dose descriptor starting point:
- NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General 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.
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.