Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 242-560-0 | CAS number: 18765-38-3
- 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:
- 44 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):
- 1
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 44.08 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEL (oral): Correction respiratory volume rat (8 hour) 1/0.38 m³/kg bw/day, Correction for respiratory volume (worker): 6.7 m³/10 m³. Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: oral 25*(1/0.38) *(6.7 m³/10 m³) = 44.08 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 2
- Justification:
- The toxicity of the registered substance is due to the haemotoxicity of the metabolite (BAA) of the hydrolysis product (2-butoxyethanol). Oral subchronic data for 2-butoxyethanol gave a similar NOAEL as was concluded in the sub-acute study on the registered substance. There is also evidence that sublethal doses of 2-butoxyethanol are protective against the haemotoxic effects of subsequent exposures, and chronic data for 2-butoxyethanol show that effects are secondary to haemotoxicity. Therefore, it is reasonable to use the assessment factor for subchronic to chronic exposure duration as a conservative measure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default for rat oral to human inhalation exposure
- AF for other interspecies differences:
- 0.1
- Justification:
- There is a well-developed PBPK model for 2-butoxyethanol and data which show humans are at least an order of magnitude less susceptible than rats to the haemolytic effects of BAA. The OECD 422 test on the registered substance clearly showed that all observed toxicity related to haemolytic effects, which it is reasonable to assume were due to the hydrolysis product. Therefore, an assessment factor of less than one is justified. This assessment factor is in line with that agreed in the EU risk assessment of 2-butoxyethanol (2008).
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default as the variation in susceptibility is not known for the human population.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA 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:
- 25 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):
- 1
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction was applied to the dose descriptor starting point.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 2
- Justification:
- The toxicity of the registered substance is due to the haemotoxicity of the metabolite (BAA) of the hydrolysis product (2-butoxyethanol). Oral subchronic data for 2-butoxyethanol gave a similar NOAEL as was concluded in the sub-acute study on the registered substance. There is also evidence that sublethal doses of 2-butoxyethanol are protective against the haemotoxic effects of subsequent exposures, and chronic data for 2-butoxyethanol show that effects are secondary to haemotoxicity. Therefore, it is reasonable to use the assessment factor for subchronic to chronic exposure duration as a conservative measure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- See explanation for interspecies differences
- AF for other interspecies differences:
- 0.1
- Justification:
- There is a well-developed PBPK model for 2-butoxyethanol and data which show humans are at least an order of magnitude less susceptible than rats to the haemolytic effects of BAA. The OECD 422 test on the registered substance clearly showed that all observed toxicity related to haemolytic effects, which it is reasonable to assume were due to the hydrolysis product. Therefore, an assessment factor of less than one is justified. This assessment factor is in line with that agreed in the EU risk assessment of 2-butoxyethanol (2008).
- AF for intraspecies differences:
- 5
- Justification:
- ECHA default
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA default
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
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.9 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):
- 2
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 21.74 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The following correction was made to the NOAEL (oral): Correction respiratory volume rat (24 hour) 1/1.15 m³/kg bw. Therefore, the corrected NOAEC for repeated-dose systemic effects via the inhalation route is: 25*(1/1.15) = 21.74 mg/m³.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 2
- Justification:
- The toxicity of the registered substance is due to the haemotoxicity of the metabolite (BAA) of the hydrolysis product (2-butoxyethanol). Oral subchronic data for 2-butoxyethanol gave a similar NOAEL as was concluded in the sub-acute study on the registered substance. There is also evidence that sublethal doses of 2-butoxyethanol are protective against the haemotoxic effects of subsequent exposures, and chronic data for 2-butoxyethanol show that effects are secondary to haemotoxicity. Therefore, it is reasonable to use the assessment factor for subchronic to chronic exposure duration as a conservative measure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- ECHA default for rat oral to human inhalation exposure
- AF for other interspecies differences:
- 0.1
- Justification:
- There is a well-developed PBPK model for 2-butoxyethanol, and data which show humans are at least an order of magnitude less susceptible than rats to the haemolytic effects of BAA. The OECD 422 test on the registered substance clearly showed that all observed toxicity related to haemolytic effects, which it is reasonable to assume were due to the hydrolysis product. Therefore, an assessment factor of less than one is justified. This assessment factor is in line with that agreed in the EU risk assessment of 2-butoxyethanol (2008).
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default as the variation in susceptibility is not known for the human population.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA 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:
- 12.5 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):
- 2
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction was applied to the dose descriptor starting point.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 2
- Justification:
- The toxicity of the registered substance is due to the haemotoxicity of the metabolite (BAA) of the hydrolysis product (2-butoxyethanol). Oral subchronic data for 2-butoxyethanol gave a similar NOAEL as was concluded in the sub-acute study on the registered substance. There is also evidence that sublethal doses of 2-butoxyethanol are protective against the haemotoxic effects of subsequent exposures, and chronic data for 2-butoxyethanol show that effects are secondary to haemotoxicity. Therefore, it is reasonable to use the assessment factor for subchronic to chronic exposure duration as a conservative measure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- See explanation in interspecies differences
- AF for other interspecies differences:
- 0.1
- Justification:
- There is a well-developed PBPK model for 2-butoxyethanol, and data which show humans are at least an order of magnitude less susceptible than rats to the haemolytic effects of BAA. The OECD 422 test on the registered substance clearly showed that all observed toxicity related to haemolytic effects, which it is reasonable to assume were due to the hydrolysis product. Therefore, an assessment factor of less than one is justified. This assessment factor is in line with that agreed in the EU risk assessment of 2-butoxyethanol (2008).
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default as the variation in susceptibility is not known for the human population.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA 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:
- 12.5 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):
- 2
- Dose descriptor starting point:
- NOAEL
- Value:
- 25 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No correction was applied to the dose descriptor starting point.
- AF for dose response relationship:
- 1
- Justification:
- ECHA default
- AF for differences in duration of exposure:
- 2
- Justification:
- The toxicity of the registered substance is due to the haemotoxicity of the metabolite (BAA) of the hydrolysis product (2-butoxyethanol). Oral subchronic data for 2-butoxyethanol gave a similar NOAEL as was concluded in the sub-acute study on the registered substance. There is also evidence that sublethal doses of 2-butoxyethanol are protective against the haemotoxic effects of subsequent exposures, and chronic data for 2-butoxyethanol show that effects are secondary to haemotoxicity. Therefore, it is reasonable to use the assessment factor for subchronic to chronic exposure duration as a conservative measure.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- See explanation in interspecies differences
- AF for other interspecies differences:
- 0.1
- Justification:
- There is a well-developed PBPK model for 2-butoxyethanol, and data which show humans are at least an order of magnitude less susceptible than rats to the haemolytic effects of BAA. The OECD 422 test on the registered substance clearly showed that all observed toxicity related to haemolytic effects, which it is reasonable to assume were due to the hydrolysis product. Therefore, an assessment factor of less than one is justified. This assessment factor is in line with that agreed in the EU risk assessment of 2-butoxyethanol (2008).
- AF for intraspecies differences:
- 10
- Justification:
- ECHA default as the variation in susceptibility is not known for the human population.
- AF for the quality of the whole database:
- 1
- Justification:
- ECHA default
- AF for remaining uncertainties:
- 1
- Justification:
- ECHA 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:
- no hazard identified
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.