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EC number: 500-039-8 | CAS number: 25322-69-4 1 - 4.5 moles propoxylated
- 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:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: See justification and comments.
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:
- 84 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: See comments for individual assessment factors
- Overall assessment factor (AF):
- 12
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 010 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL of 470mg/kg.day identified as the key study is extrapolated from the oral to the dermal route by using absorption factors of 86% for the oral route and 40% fo the dermal route.
- AF for dose response relationship:
- 1
- Justification:
- Based on a NOAEL. Default factor used.
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL based on a chronic study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Scaling factor for rats to humans.
- AF for other interspecies differences:
- 1
- Justification:
- recommended factor according to ECETOC Technical Report #110.
- AF for intraspecies differences:
- 3
- Justification:
- default intraspecies factor for workers according to ECETOC Technical Report #86.
- 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:
- no hazard identified
Additional information - workers
According to the REACH guidance on information requirements and chemical safety assessment a leading DN(M)EL needs to be derived for every relevant human population and every relevant route, duration and frequency of exposure, if feasible.
The available toxicokinetic study on one of the major constituents of ‘propane-1,2-diol, propoxylated’, triipropylene glycol, indicated a recovery of at least 86% of the total dose administered orally. Based on this, the oral absorption percentage used for DNEL derivation (in case of route-to-route extrapolation) is set to 86%. As only limited data are available on inhalation absorption, the default value of 100%, as set in Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, will be used for DNEL derivation in case of route-to-route extrapolation.
Regarding dermal absorption, the available in vitro studies on mono- and dipropylene glycol indicated 0.14% and 0.075% dermal absorption, respectively, using an infinite exposure conditions. Based on expert judgment, a value of 40% for dermal absorption has been chosen to be used in the risk assessment and DNEL derivation. This value has been chosen as an average value between the percentage of dermal absorption obtained in the study and the maximal oral absorption (corresponding to 86%), and is considered to represent a worst-case approach.
Acute toxicity
‘Propane-1,2-diol, propoxylated’ is not classified for acute toxicity and therefore derivation of a DNELacute is not necessary.
‘Propane-1,2-diol, propoxylated’ is not irritating to the skin, eyes and respiratory tract and not sensitising to the skin. Therefore, no DNELs are derived for these endpoints.
Long-term toxicity
Regarding repeated dose toxicity, the lowest NOAEL of 470 mg/kg bw/day, established in the 2-year drinking water study with rats with dipropylene glycol (National Toxicology Program, 2004), shall be used for risk assessment and DNEL derivation for systemic effects by long-term exposure for ‘propane-1,2-diol, propoxylated’.
For the dermal route of exposure, a route-to-route extrapolation from the 2 year dipropylene glycol oral study was performed to derive a dermal DNEL for ‘propane-1,2-diol, propoxylated’. Although extrapolation to inhalation exposure is also mathematically possible for ‘propane-1,2-diol, propoxylated’, the resulting air concentration appears to be higher than a saturated atmosphere and hence unlikely to be achieved under normal conditions of use. Therefore no inhalation DNEL is extrapolated from the available oral repeated exposure data for dipropylene glycol.
The available subchronic inhalation study with monopropylene glycol indicated the occurrence of alleged nasal haemorrhaging in the exposed animals at all dose levels (LOAEL of 160 mg/m3). This "haemorrhaging" is however likely to be pigment/porphyrin staining following an increase in lacrimal secretion caused by the mildly irritating or drying effect of monopropylene glycol aerosols on mucous membranes and is thus not considered a substance-specific effect. Therefore the limit concentration of 10 mg/m3established for aerosols by AIHA shall be regarded as a DNEL for local effects for ‘propane-1,2-diol, propoxylated’, as it has been established by credible authoritative body, is lower than the calculated DNEL for monopropylene glycol (18 mg/m3 for workers, using the assessment factors recommended by ECETOC) and is adopted by industry.
‘Propane-1,2-diol, propoxylated’ is assessed to be non-mutagenic and not carcinogenic. Based on this, no separate risk characterisation for mutagenicity and carcinogenicity is needed.
‘Propane-1,2-diol, propoxylated’ is assessed to be not a reproductive or developmental toxicant based on the available studies with its lower homologues and constituents mono-, di- and tripropylene glycol. The available studies indicated the absence of adverse effects on either reproductive performance or development of offspring up to the highest doses tested in all cases. As these doses were usually much higher than the established NOAEL for repeated dose toxicity (470 mg/kg bw/d (see above)), no separate DNEL derivation shall be performed for these endpoints.
DNEL calculation
The DNELs are derived using the scientifically based assessment factors as reported by ECETOC (ECETOC (2003). Derivation of assessment factors for human health risk assessment. Technical Report # 110).
Long term – dermal, systemic effects
Description |
Value |
Remark |
|
Step 1) Relevant dose-descriptor |
NOAEL: 470 mg/kg bw/day |
Based on effects on liver and nose in a 2-year drinking water study with rats on dipropylene glycol |
|
Step 2) Modification of starting point |
0.86
0.40
|
Proportion of the oral absorption, based on the available toxicokinetics study with tripropylene glycol; Proportion dermal absorption (reasonable worst case for oral-to-dermal extrapolation) |
|
Step 3) Assessment factors |
|
|
|
Interspecies |
4 |
Allometric scaling factor for rat |
|
Intraspecies |
3 |
The default assessment factor for workers, as proposed in the ECETOC guidance |
|
Exposure duration |
1 |
As the NOAEL is obtained in a chronic study, no correction for exposure duration is necessary |
|
Dose response |
1 |
|
|
Quality of database |
1 |
|
|
DNEL |
Value |
||
|
470 x (0.86/0.40) / (4 x 3 x 1 x 1 x 1) = 84 mg/kg bw/day |
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:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- other: See justification and comments.
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:
- 51 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: See comments for individual assessment factors.
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 1 010 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- The NOAEL of 470mg/kg.day identified as the key study is extrapolated from the oral to the dermal route by using absorption factors of 86% for the oral route and 40% fo the dermal route.
- AF for dose response relationship:
- 1
- Justification:
- Based on a NOAEL. Default factor used.
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL based on a chronic study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Scaling factor for rats to humans.
- AF for other interspecies differences:
- 1
- Justification:
- recommended factor according to ECETOC Technical Report #110.
- AF for intraspecies differences:
- 5
- Justification:
- default intraspecies factor for consumers according to ECETOC Technical Report #110.
- 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:
- 24 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- other: See comments for individual assessment factors.
- Overall assessment factor (AF):
- 20
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 470 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- Based on a NOAEL. Default factor used.
- AF for differences in duration of exposure:
- 1
- Justification:
- NOAEL based on a chronic study.
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- Scaling factor for rats to humans.
- AF for other interspecies differences:
- 1
- Justification:
- recommended factor according to ECETOC Technical Report #110.
- AF for intraspecies differences:
- 5
- Justification:
- default intraspecies factor for consumers according to ECETOC Technical Report #110.
- 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:
- no hazard identified
Additional information - General Population
According to the REACH guidance on information requirements and chemical safety assessment a leading DN(M)EL needs to be derived for every relevant human population and every relevant route, duration and frequency of exposure, if feasible.
The available toxicokinetic study on one of the major constituents of ‘propane-1,2-diol, propoxylated’, tripropylene glycol, indicated a recovery of at least 86% of the total dose administered orally. Based on this, the oral absorption percentage used for DNEL derivation (in case of route-to-route extrapolation) is set to 86%. As only limited data are available on inhalation absorption, the default value of 100%, as set in Chapter R.8 of REACH Guidance on information requirements and chemical safety assessment, will be used for DNEL derivation in case of route-to-route extrapolation.
Regarding dermal absorption, the available in vitro studies on mono- and dipropylene glycol indicated 0.14% and 0.075% dermal absorption, respectively, using an infinite exposure conditions. Based on expert judgment, a value of 40% for dermal absorption has been chosen to be used in the risk assessment and DNEL derivation. This value has been chosen as an average value between the percentage of dermal absorption obtained in the study and the maximal oral absorption (corresponding to 86%), and is considered to represent a worst-case approach.
Acute toxicity
‘Propane-1,2-diol, propoxylated’ is not classified for acute toxicity and therefore derivation of a DNELacute is not necessary.
‘Propane-1,2-diol, propoxylated’ is not irritating to the skin, eyes and respiratory tract and not sensitising to the skin. Therefore, no DNELs are derived for these endpoints.
Long-term toxicity
Regarding repeated dose toxicity, the lowest NOAEL of 470 mg/kg bw/day, established in the 2-year drinking water study with rats with dipropylene glycol (National Toxicology Program, 2004), shall be used for risk assessment and DNEL derivation for systemic effects by long-term exposure for ‘propane-1,2-diol, propoxylated’.
For the dermal route of exposure, a route-to-route extrapolation from the 2 year dipropylene glycol oral study was performed to derive a dermal DNEL for ‘propane-1,2-diol, propoxylated’. Although, extrapolation to inhalation exposure is also mathematically possible for ‘propane-1,2-diol, propoxylated’, the resulting air concentration appears to be higher than a saturated atmosphere and hence unlikely to be achieved under normal conditions of use. Therefore no inhalation DNEL is extrapolated from the available oral repeated exposure data for dipropylene glycol.
The available subchronic inhalation study with monopropylene glycol indicated the occurrence of alleged nasal haemorrhaging in the exposed animals at all dose levels (LOAEL of 160 mg/m3). This "haemorrhaging" is however likely to be pigment/porphyrin staining following an increase in lacrimal secretion caused by the mildly irritating or drying effect of monopropylene glycol aerosols on mucous membranes and is thus not considered a substance-specific effect. Therefore the limit concentration of 10 mg/m3established for aerosols by AIHA shall be regarded as a DNEL for local effects for ‘propane-1,2-diol, propoxylated’, as it has been established by credible authoritative body, is lower than the calculated DNEL for monopropylene glycol (11 mg/m3 for general population, calculated using assessment factors recommended by ECETOC) and is adopted by industry. This value is considered to be sufficient to ensure the protection of both workers and general population.
‘Propane-1,2-diol, propoxylated’ is assessed to be non-mutagenic and not carcinogenic. Based on this, no separate risk characterisation for mutagenicity and carcinogenicity is needed.
‘Propane-1,2-diol, propoxylated’ is assessed to be not a reproductive or developmental toxicant based on the available studies with its lower homologues and constituents mono-, di- and tripropylene glycol. The available studies indicated the absence of adverse effects on either reproductive performance or development of offspring up to the highest doses tested in all cases. As these doses were usually much higher than the established NOAEL for repeated dose toxicity (470 mg/kg bw/d (see above)), no separate DNEL derivation shall be performed for these endpoints.
DNEL calculation
The DNELs are derived using the scientifically based assessment factors as reported by ECETOC (ECETOC (2003). Derivation of assessment factors for human health risk assessment. Technical Report # 110).
Long term – dermal, systemic effects
Description |
Value |
Remark |
|
Step 1) Relevant dose-descriptor |
NOAEL: 470 mg/kg bw/day |
Based on effects on liver and nose in a 2-year drinking water study with rats on dipropylene glycol |
|
Step 2) Modification of starting point |
0.86
0.40
|
Proportion of the oral absorption, based on the available toxicokinetics study with tripropylene glycol; Proportion dermal absorption (reasonable worst case for oral-to-dermal extrapolation) |
|
Step 3) Assessment factors |
|
|
|
Interspecies |
4 |
Allometric scaling factor for rat |
|
Intraspecies |
5 |
The default assessment factor for general population, as proposed in the ECETOC guidance |
|
Exposure duration |
1 |
As the NOAEL is obtained in a chronic study, no correction for exposure duration is necessary |
|
Dose response |
1 |
|
|
Quality of database |
1 |
|
|
DNEL |
Value |
||
|
470 x (0.86/0.40) / (4 x 5 x 1 x 1 x 1) = 51 mg/kg bw/day |
Long term - oral, systemic effects
Description |
Value |
Remark |
|
Step 1) Relevant dose-descriptor |
NOAEL: 470 mg/kg bw/day |
Based on effects on liver and nose in a 2-year drinking water study with rats on dipropylene glycol |
|
Step 2) Modification of starting point |
1
|
No modification of the starting point is necessary |
|
Step 3) Assessment factors |
|
|
|
Interspecies |
4 |
Allometric scaling factor for rat |
|
Intraspecies |
5 |
The default assessment factor for general population, as proposed in the ECETOC Guidance |
|
Exposure duration |
1 |
As the NOAEL is obtained in a chronic study, no correction for exposure duration is necessary |
|
Dose response |
1 |
|
|
Quality of database |
1 |
|
|
DNEL |
Value |
||
|
470 / (4 x 5 x 1 x 1 x 1) = 24 mg/kg bw/day |
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.