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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
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EC number: 213-497-6 | CAS number: 959-26-2
- 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:
- 60.6 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):
- 12.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 307 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 758 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting NOAEL is based on the chronic oral study, therefore, there no additional correction for differences between human & experimental exposure conditions required.
Correction for differences in respiratory volume (workers): 2.63
Correction for differences in bioavailability: 1
Correction for light activity at work: 0.67
Correction for differences between human and experimental exposure conditions (workers): 1.4
- AF for dose response relationship:
- 1
- Justification:
- Substance has low toxicity and dose-response curve is not steep
- AF for differences in duration of exposure:
- 1
- Justification:
- Default value for duration extrapolation of a chronic to chronic assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required when converting animal oral exposure to human inhalation exposure.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for intraspecies differences (worker)
- AF for the quality of the whole database:
- 1
- Justification:
- There are sufficient studies available to indicate data from this study are representative.
- AF for remaining uncertainties:
- 1
- Justification:
- No data indicating there should be additional concerns
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:
- 86 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):
- 50
- Dose descriptor starting point:
- NOAEL
- Value:
- 307 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 4 298 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting NOAEL is based on the chronic oral study, therefore, there no additional correction for differences between human & experimental exposure conditions required.
Correction for differences in respiratory volume (workers): 1
Correction for differences in bioavailability: 10
Correction for light activity at work: 1
Correction for differences between human and experimental expousre conditions (workers): 1.4
- AF for dose response relationship:
- 1
- Justification:
- Substance has low toxicity and dose-response curve is not steep
- AF for differences in duration of exposure:
- 1
- Justification:
- Default value for duration extrapolation of a chronic to chronic assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for allometric scaling for rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining interspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- Default assessment factor for intraspecies differences (worker)
- AF for the quality of the whole database:
- 1
- Justification:
- There are sufficient studies available to indicate data from this study are representative.
- AF for remaining uncertainties:
- 1
- Justification:
- No data indicating there should be additional concerns.
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
BHET is metabolized to TA and EG. TA is not classified according to the criteria of the CLP; therefore based on this criteria, there is no hazard identified following exposure to TA. However, repeated oral exposure to sublethal doses of EG may lead to oxalate nephrosis (renal destruction by calcium-oxalate crystals) and is therefore considered to be relevant for a STOT classification. In terms of EG renal toxicity, rats appear to be more resistant than rabbits and less resistant than mice (NTP, 2004), however, different strains of rats may show different sensitivities with more severity and more accumulation of oxalate in the kidneys of Wistar rats than Fisher rats (Cruzan et al., 2004). All sub-chronic and chronic oral studies in rats appear to converge in a NOAEL around 150 mg/kg bw/day (Corley et al, 2008). Information on EG is considered to be directly applicable to an equivalent molar amount of the EG constituent/metabolite arising from exposure to BHET, wherein 1 mole of BHET provides 2 moles of EG (see TK statement). Therefore, for the safety assessment of workers for systemic effects following inhalation and/or dermal exposure a chronic BHET NOAEL of 307 mg/kg bw/day is considered.
The CLP self-classification of BHET is STOT RE 2 (oral, kidney). Systemic acute/short-term effects via any route of exposure are not anticipated. Additionally, local effects via any route of exposure are not anticipated.
References:
NTP (National Toxicology Program). 2004. NTP-CERHR monograph on the potential human reproductive and developmental effects of ethylene glycol. NTP CERHR MON, (11), pp.1-III36.
Cruzan G, Corley RA, Hard GC, Mertens JJ, McMartin KE, Snellings WM, Gingell R, Deyo JA. 2004. Subchronic toxicity of ethylene glycol in Wistar and F-344 rats related to metabolism and clearance of metabolites. Toxicological Sciences, 81(2), pp.502-511.
Corley RA, Wilson DM, Hard GC, Stebbins KE, Bartels MJ, Soelberg JJ, Dryzga MD, Gingell R, McMartin KE, Snellings WM. 2008. Dosimetry considerations in the enhanced sensitivity of male Wistar rats to chronic ethylene glycol-induced nephrotoxicity. Toxicology and applied pharmacology, 228(2), pp.165-178.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10.7 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):
- 25
- Dose descriptor starting point:
- NOAEL
- Value:
- 307 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 267 mg/m³
- Explanation for the modification of the dose descriptor starting point:
The starting NOAEL is based on the chronic oral study, therefore, there no additional correction for differences between human & experimental exposure conditions required.
Correction for differences in respiratory volume (general population): 0.87
Correction for differences in bioavailability: 1
Correction for differences between human and experimnetal exposure conditions (general population): 1
- AF for dose response relationship:
- 1
- Justification:
- Substance has low toxicity and dose-response curve is not steep
- AF for differences in duration of exposure:
- 1
- Justification:
- Default value for duration extrapolation of a chronic to chronic assessment
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Not required when converting animal oral exposure to human inhalation exposure.
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for intraspecies differences (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- There are sufficient studies available to indicate data from this study are representative.
- AF for remaining uncertainties:
- 1
- Justification:
- No data indicating there should be additional concerns.
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:
- 30.7 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):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 307 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 3 070 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting NOAEL is based on the chronic oral study, therefore, there no additional correction for differences between human & experimental exposure conditions required.
Correction for differences in respiratory volume (general population): 1
Correction for differences in bioavailability: 10
Correction for differences between human and experimental expousre conditions (general population: 1
- AF for dose response relationship:
- 1
- Justification:
- Substance has low toxicity and dose-response curve is not steep
- AF for differences in duration of exposure:
- 1
- Justification:
- Default value for duration extrapolation of a chronic to chronic assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for allometric scaling for rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for intraspecies differences (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- There are sufficient studies available to indicate data from this study are representative.
- AF for remaining uncertainties:
- 1
- Justification:
- No data indicating there should be additional concerns.
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:
- 3.07 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other:
- Overall assessment factor (AF):
- 100
- Dose descriptor starting point:
- NOAEL
- Value:
- 307 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 307 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
The starting NOAEL is based on the chronic oral study, therefore, there no additional correction for differences between human & experimental exposure conditions required.
Correction for differences in respiratory volume general population: 1
Correction for differences in bioavailability: 1
Correction for differences between human and experimental exposure conditions (general population): 1
- AF for dose response relationship:
- 1
- Justification:
- Substance has low toxicity and dose-response curve is not steep
- AF for differences in duration of exposure:
- 1
- Justification:
- Default value for duration extrapolation of a chronic to chronic assessment
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Default AF for allometric scaling for rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- Default assessment factor for remaining interspecies differences
- AF for intraspecies differences:
- 10
- Justification:
- Default assessment factor for intraspecies differences (general population)
- AF for the quality of the whole database:
- 1
- Justification:
- There are sufficient studies available to indicate data from this study are representative.
- AF for remaining uncertainties:
- 1
- Justification:
- No data indicating there should be additional concerns.
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
Based on use pattern, manufacture of the BHET, and use of the BHET at industrial sites where the substance will be incorporated into a polymer, no exposure to the general public is anticipated at this time. The systemic long term exposure DNELs following, inhalation, dermal or oral exposure by the general public are included to ensure unforeseen future users where the general public are exposed is addressed in the safety assessment.
BHET is metabolized to TA and EG. TA is not classified according to the criteria of the CLP; therefore based on this criteria, there is no hazard identified following exposure to TA. However, repeated oral exposure to sublethal doses of EG may lead to oxalate nephrosis (renal destruction by calcium-oxalate crystals) and is therefore considered to be relevant for a STOT classification. In terms of EG renal toxicity, rats appear to be more resistant than rabbits and less resistant than mice (NTP, 2004), however, different strains of rats may show different sensitivities with more severity and more accumulation of oxalate in the kidneys of Wistar rats than Fisher rats (Cruzan et al., 2004). All sub-chronic and chronic oral studies in rats appear to converge in a NOAEL around 150 mg/kg bw/day (Corley et al, 2008). Information on EG is considered to be directly applicable to an equivalent molar amount of the EG constituent/metabolite arising from exposure to BHET, wherein 1 mole of BHET provides 2 moles of EG (see TK statement). Therefore, for the safety assessment of workers for systemic effects following inhalation and/or dermal exposure a chronic BHET NOAEL of 307 mg/kg bw/day is considered.
The CLP self-classification of BHET is STOT RE 2 (oral, kidney). Systemic acute/short-term effects via any route of exposure are not anticipated. Additionally, local effects via any route of exposure are not anticipated.
References:
NTP (National Toxicology Program). 2004. NTP-CERHR monograph on the potential human reproductive and developmental effects of ethylene glycol. NTP CERHR MON, (11), pp.1-III36.
Cruzan G, Corley RA, Hard GC, Mertens JJ, McMartin KE, Snellings WM, Gingell R, Deyo JA. 2004. Subchronic toxicity of ethylene glycol in Wistar and F-344 rats related to metabolism and clearance of metabolites. Toxicological Sciences, 81(2), pp.502-511.
Corley RA, Wilson DM, Hard GC, Stebbins KE, Bartels MJ, Soelberg JJ, Dryzga MD, Gingell R, McMartin KE, Snellings WM. 2008. Dosimetry considerations in the enhanced sensitivity of male Wistar rats to chronic ethylene glycol-induced nephrotoxicity. Toxicology and applied pharmacology, 228(2), pp.165-178.
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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