Registration Dossier
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EC number: 500-012-0 | CAS number: 9004-77-7
- 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:
- 245 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: see justification and comments below.
- Overall assessment factor (AF):
- 6
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 490 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Long term oral systemic DNEL is based on weight of evidence from two structurally related substances by read across (interpolation). The estimated NOAEL is from a repeat dose study in rats (BRRC (1990), molecular weight corrected NOEC=640mg/kgbw/day). This is converted to an inhalation dose by dividing by 0.38 (Example R-82 p65 of guidance) = 1684mg/m3. Assuming 75% uptake of inhaled substance (upper end of range normally seen with oxygenated solvents) this is equivalent to an inhaled concentration (external) of 2245mg/m3. Corrected for basal load (light exercise, x0.667) this is equivalent to a human concentration of 1490mg/m3.
Molecular weight correction was performed on the effect level used to determine the DNEL. The molecular weight used for this test material is based on a weighted average using the typical composition. The molecular weight of the components were multiplied by their typical percentage and then added up. This resulted in the weighted molecular weight of 260.
- AF for dose response relationship:
- 1
- Justification:
- Based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic default factor.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required for the inhalation route where the units are in mg/m3.
- AF for other interspecies differences:
- 1
- Justification:
- No additional factor deemed necessary. See detailed justification in document attached to this record.
- AF for intraspecies differences:
- 3
- Justification:
- Proposed factor for workers. See detailed justification in document attached to this record.
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 265 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: see justification and comments below.
- Overall assessment factor (AF):
- 24
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Long term dermal systemic DNEL based on data from a structurally related substance by read across.. The estimated NOAEL is from a repeat dose study in rats (Dow (1990), molecular weight corrected NOEC=6400mg/kgbw/day). Dermal absorption is assumed to be 100%, which is likely to be exceptionally conservative.
Molecular weight correction was performed on the effect level used to determine the DNEL. The molecular weight used for this test material is based on a weighted average using the typical composition. The molecular weight of the components were multiplied by their typical percentage and then added up. This resulted in the weighted molecular weight of 260.
- AF for dose response relationship:
- 1
- Justification:
- Based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic default factor.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- No additional factor deemed necessary. See detailed justification in document attached to this record.
- AF for intraspecies differences:
- 3
- Justification:
- Proposed factor for workers. See detailed justification in document attached to this record.
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- high hazard (no threshold derived)
Additional information - workers
The evaluation in this section is based on the data fora significant and representative component of this substance: 2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol. This component is expected to exhibit the highest level of toxicity (within an overall spectrum of very low toxicity) and therefore an evaluation based on this component alone will produce a conservative assessment for this UVCB/multicomponent substance.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 149 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: see justification and comments below.
- Overall assessment factor (AF):
- 10
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 1 490 mg/m³
- Explanation for the modification of the dose descriptor starting point:
Long term oral systemic DNEL is based on weight of evidence from two structurally related substances by read across (interpolation). The estimated NOAEL is from a repeat dose study in rats (BRRC (1990), molecular weight corrected NOEC=640mg/kgbw/day). This is converted to an inhalation dose by dividing by 0.38 (Example R-82 p65 of guidance) = 1684mg/m3. Assuming 75% uptake of inhaled substance (upper end of range normally seen with oxygenated solvents) this is equivalent to an inhaled concentration (external) of 2245mg/m3. Corrected for basal load (light exercise, x0.667) this is equivalent to a human concentration of 1490mg/m3.
Molecular weight correction was performed on the effect level used to determine the DNEL. The molecular weight used for this test material is based on a weighted average using the typical composition. The molecular weight of the components were multiplied by their typical percentage and then added up. This resulted in the weighted molecular weight of 260.
- AF for dose response relationship:
- 1
- Justification:
- Based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic default factor.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required for the inhalation route where the units are in mg/m3.
- AF for other interspecies differences:
- 1
- Justification:
- No additional factor deemed necessary. See detailed justification in document attached to this record.
- AF for intraspecies differences:
- 5
- Justification:
- Proposed factor for consumers. See detailed justification in document attached to this record.
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 160 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: See justification and comments below.
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 6 400 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
Long term dermal systemic DNEL based on data from a structurally related substance by read across.. The estimated NOAEL is from a repeat dose study in rats (Dow (1990), molecular weight corrected NOEC=6400mg/kgbw/day). Dermal absorption is assumed to be 100%, which is likely to be exceptionally conservative.
Molecular weight correction was performed on the effect level used to determine the DNEL. The molecular weight used for this test material is based on a weighted average using the typical composition. The molecular weight of the components were multiplied by their typical percentage and then added up. This resulted in the weighted molecular weight of 260.
- AF for dose response relationship:
- 1
- Justification:
- Based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic default factor.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- No additional factor deemed necessary. See detailed justification in document attached to this record.
- AF for intraspecies differences:
- 5
- Justification:
- Proposed factor for workers. See detailed justification in document attached to this record.
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 16 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: See justification and comments below
- Overall assessment factor (AF):
- 40
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 640 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Based on a NOAEL.
- AF for differences in duration of exposure:
- 2
- Justification:
- Sub-chronic to chronic default factor.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Rat to human extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- No additional factor deemed necessary. See detailed justification in document attached to this record.
- AF for intraspecies differences:
- 5
- Justification:
- Proposed factor for workers. See detailed justification in document attached to this record.
- AF for the quality of the whole database:
- 1
- Justification:
- default
- AF for remaining uncertainties:
- 1
- Justification:
- default
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- medium hazard (no threshold derived)
Additional information - General Population
The evaluation in this section is based on the data for a significant and representative component of this substance: 2 -(2 -(2 -butoxyethoxy)ethoxy)ethanol. This component is expected to exhibit the highest level of toxicity (within an overall spectrum of very low toxicity) and therefore an evaluation based on this component alone will produce a conservative assessment for this UVCB/multicomponent substance.
There is no data that indicates long or short term local dermal effects.
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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