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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 203-786-5 | CAS number: 110-63-4
- 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:
- 136 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):
- 3
- Dose descriptor starting point:
- NOAEL
- Value:
- 225 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 410 mg/m³
- Explanation for the modification of the dose descriptor starting point:
This starting point was adjusted for molecular weight, a factor of 1 was used to modify the starting point for absorption from oral to inhalation, 2.6 was used to modify the starting point from oral to 8hr inhalation exposure, and 0.67 was used to modify the starting point to light work.
DD starting point 225 225 mg/kg, 2-yr oral, rat with GBL/96-48-0 (NTP, 1992) MW adjustment 1.05 *BDO/GBL = 90.1g/mol/86.1g/mol absorption 1 100% route to route 2.60 *1/0,38 (8h inhalation) no - light work 0.67 * 6,7 m3/10 m3 - AF for dose response relationship:
- 1
- Justification:
- Default; study according to NTP guidelines with two doses per sex
- AF for differences in duration of exposure:
- 1
- Justification:
- Default; chronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Default; no further allometric scaling has to be applied in case of oral to inhalation route to route extrapolation.
- AF for other interspecies differences:
- 1
- Justification:
- Toxicokinetic study shows rapid metabolism of BDO resulting in formation of products entering tricarboxylic acid cycle. Considering this there is no need for an additional AF. Furthermore, see Justification for intraspecies AF.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC proposes an AF of 3 for intraspecies x other interspecies factor (excluding allometry) for workers (ECETOC TR No. 110, 2010)
- AF for the quality of the whole database:
- 1
- Justification:
- Sufficient reliable data available
- AF for remaining uncertainties:
- 1
- Justification:
- Default
Acute/short term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 958 mg/m³
- Most sensitive endpoint:
- acute toxicity
- Route of original study:
- By inhalation
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 3
- Dose descriptor starting point:
- LOAEC
- Value:
- 5 100 mg/m³
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 874 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The DNEL is valid for up to 15-minutes of exposure and was derived from a LOAEC 5100 mg/m3 (4-hour, rat) and corrected to a NOAEC which was corrected for light work a time correction (4h ->15 min) was also applied as calculated using modified Haber's Law.
no - light work 0.67 *6,7 m3/10 m3 LOAEC -> NOAEC 3 Standard conversion factor time 4h -> 15 min Factor: 2.51984
Justification: The factor 2.51984 = 3√(4h/0.25h) is based on the modification for Haber´s Law Cn x t = k according to ECHA Guidance R.7a, v6.0, July 2017.
- AF for dose response relationship:
- 1
- Justification:
- Acute data used: LOAEC to NOAEC taken into account when modifying starting dose.
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Inhalation study used to determine DNEL
- AF for other interspecies differences:
- 1
- Justification:
- Toxicokinetic study shows rapid metabolism of BDO resulting in formation of products entering tricarboxylic acid cycle. Considering this there is no need for an additional AF. Furthermore, see Justification for intraspecies AF.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC proposes an AF of 3 for intraspecies x other interspecies factor (excluding allometry) for workers (ECETOC TR No. 110, 2010)
- AF for the quality of the whole database:
- 1
- Justification:
- Sufficient reliable data available
- AF for remaining uncertainties:
- 1
- Justification:
- Default
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:
- 19 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):
- 12
- Dose descriptor starting point:
- NOAEL
- Value:
- 225 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 235 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The DNEL is valid for typical worker exposures and assumes 100% absorption of external dose. It was derived from a NOAEL of 225 mg/kg from a 2-year oral rat study on γ-butyrolactone (CAS 96-48-0, see Toxicokinetic Section for justification) as the starting point. This starting point was adjusted for molecular weight.
DD starting point 225 225 mg/kg, 2-yr oral, rat with GBL/96-48-0 (NTP, 1992) MW adjustment 1.05 *BDO/GBL = 90.1g/mol/86.1g/mol absorption 1 100% route to route 1.00 oral - dermal - AF for dose response relationship:
- 1
- Justification:
- Default; study according to NTP guidelines with two doses per sex
- AF for differences in duration of exposure:
- 1
- Justification:
- Default - chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default; rat -> human
- AF for other interspecies differences:
- 1
- Justification:
- Toxicokinetic study shows rapid metabolism of BDO resulting in formation of products entering tricarboxylic acid cycle. Considering this there is no need for an additional AF. Furthermore, see Justification for intraspecies AF.
- AF for intraspecies differences:
- 3
- Justification:
- ECETOC proposes an AF of 3 for intraspecies x other interspecies factor (excluding allometry) for workers (ECETOC TR No. 110, 2010)
- AF for the quality of the whole database:
- 1
- Justification:
- Sufficient reliable data available
- 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:
- no hazard identified
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- no hazard identified
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:
- 8 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):
- 20
- Dose descriptor starting point:
- NOAEL
- Value:
- 225 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 168 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
This starting point was chosen as the lowest, most relevant, and
most reliable guideline study result to prevent the critical effect of central nervous system depression (sedation) and was adjusted to account for the molecular weight difference between γ-butyrolactone and 1,4-butanediol by multiplying the starting point by 90/86 or 1.046. Consistent with Chapter R.8 (May
2008) of the REACH guidance and with ECETOC Technical Report No. 86 (February 2003), a factor of 0.71 was used to modify the starting point from 5 days per week to 7 days per week.DD starting point 225 225 mg/kg, 2-yr oral, rat with GBL/96-48-0 (NTP, 1992) MW adjustment 1.05 *BDO/GBL = 90.1g/mol/86.1g/mol Study adjustment 0.71 5d/wk -> 7d/wk - AF for dose response relationship:
- 1
- Justification:
- Default; study according to NTP guidelines with two doses per sex
- AF for differences in duration of exposure:
- 1
- Justification:
- Default: chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default; rat -> human
- AF for other interspecies differences:
- 1
- Justification:
- Toxicokinetic study shows rapid metabolism of BDO resulting in formation of products entering tricarboxylic acid cycle. Considering this there is no need for an additional AF. Furthermore, see Justification for intraspecies AF.
- AF for intraspecies differences:
- 5
- Justification:
- ECETOC proposes an AF of 5 for intraspecies x other interspecies factor (excluding allometry) for GP (ECETOC TR No. 110, 2010)
- AF for the quality of the whole database:
- 1
- Justification:
- sufficient reliable data available
- 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:
- 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.