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Diss Factsheets
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EC number: 203-572-1 | CAS number: 108-32-7
- 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:
- 70.53 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):
- 62.5
- Dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 4 408 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As stated above, the oral 90 days repeated dose toxicity study of Huntsman (1989) was observed to be the most sensitive study and it is used to derive a DNEL long-term exposure, systemic effects, using a starting point of 5000 mg/kg bw/day.
For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point = 5000 mg/kg bw/day x 1/(0.38 m³/kg/day) x 6.7 m³/10 m³ x 0.5 = 4408 mg/m³. The oral dose for rats is converted to the corresponding air concentration using a standard breathing volume for the rat (0.38 m³/kg for 8 hours exposure of workers). For workers the resulting air concentration needs to be additionally corrected for the difference between basal caloric demand and caloric demand under light activity. This correction factor is derived from the inhaled volumes in 8 hours under the respective conditions (6.7 m³ for base level, 10 m³ for light activity). In addition, the NOAEL needs to be divided by 2 as the bioavailability via the inhalation route is considered as 100%, while for oral exposure this is only 50% (See toxicokinetic assessment in section 7.1 of the IUCLID file).
- AF for dose response relationship:
- 2.5
- Justification:
- addressing the uncertainty related to the NOAEL used for DNEL derivation
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Covered by calculation for route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 5
- Dose descriptor:
- NOAEC
- Value:
- 100 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- default assessment factor
- AF for differences in duration of exposure:
- 1
- Justification:
- default assessment factor for local effects
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default assessment factor (local effects)
- AF for other interspecies differences:
- 1
- Justification:
- default assessment factor (local effects)
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 20 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):
- 250
- Dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No long-term dermal toxicity studies are available for propylene carbonate. However, data from other repeated toxicity studies could be used after extrapolation to the dermal route. One key study is available for the inhalation route: a 90-day repeated inhalation study (Bushy Run Research Center, 1991). In addition, two reliable long-term toxicity tests are available for the oral route: a 90 days repeated dose toxicity test (Huntsman, 1989) and a prenatal developmental toxicity study (Huntsman, 1988).
In the 90-day repeated inhalation study (Bushy Run Research Center, 1991), rats were exposed at dose levels of 100, 500 and 1000 mg/m³ (nominal). Repeated exposure to propylene carbonate at concentrations up to 1000 mg/m³ produced only signs of minimal irritation to the eyes in rats. The NOAEC (systemic effects) was derived to be 1000 mg/m³ and the NOAEC (local effects) was derived to be 100 mg/m³. Although 100% absorption is expected after inhalation exposure to propylene carbonate, no systemic adverse effects were observed up to the highest dose.
Huntsman (1989) investigated the oral toxicity of propylene carbonate after repeated exposure (90 days) in male/female Sprague-Dawley rats. The oral administration of propylene carbonate (5 days a week) over a period of 90 days did not exert an apparent toxicological effect (NOAEL of > 5000 mg/kg bw/day).
Huntsman (1988) performed a prenatal developmental toxicity study in 27 Sprague-Dawley rats at dose levels of 1000, 3000 and 5000 mg/kg bw/day and reported that there were no gross fetal malformations observed in any dose group. Albeit maternal toxicity, development of fetuses was not affected in all surviving rats up to the highest concentration. The comparison of the data from both studies indicate that prolongation of treatment does not increase toxicity: if mortality was indeed treatment-related, gestation rather than time seems to sensitize to propylene carbonate-induced toxicity.
In conclusion and as maternal effects occurred at doses where no developmental effects were observed (i.e. 1000 mg/kg bw/day), the 90 days repeated dose study was considered as the most reliable and relevant study. The NOAEL of 5000 mg/kg bw/d was therefore selected as starting point for the DNEL derivation for long-term exposure, systemic effects for the dermal route. The uncertainty related to using a higher NOAEL as starting dose is covered by an additional assessment factor of 2.5 for dose response relationship.
For route-to-route extrapolation (oral to dermal), no default factor (i. e. factor 1) should be applied as part of the overall assessment factor, as it is assumed that dermal absorption will not be higher than oral absorption (See toxicokinetic assessment in section 7.1 of the IUCLID file).
- AF for dose response relationship:
- 2.5
- Justification:
- addressing the uncertainty related to the NOAEL used for DNEL derivation
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 5
- Justification:
- worker population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
Local effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 10 mg/cm²
DNEL related information
- DNEL derivation method:
- other: long-term, inhalation DNEL for local effects: interspecies (1: local effects) x intraspecies (10) x exposure duration (1: local effects)
- Dose descriptor:
- NOAEC
- Value:
- 100 mg/m³
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 17.4 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):
- 125
- Dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 2 174 mg/m³
- Explanation for the modification of the dose descriptor starting point:
As stated above, the oral 90 days repeated dose toxicity study of Huntsman (1989) was observed to be the most sensitive study and it is used to derive a DNEL long-term exposure, systemic effects, using a starting point of 5000 mg/kg bw/day.
For the route-to-route extrapolation from oral to inhalation, the dose descriptor starting point = 5000 mg/kg bw/day x 0.5 / 1.15 m³/kg = 2174 mg/m³. The oral dose for rats is converted to the corresponding air concentration using a standard breathing volume for the rat (1.15 m³/kg for 24 hours exposure). In addition, the NOAEL needs to be divided by 2 as the bioavailability via the inhalation route is considered as 100%, while for oral exposure this is only 50% (See toxicokinetic assessment in section 7.1 of the IUCLID file).
- AF for dose response relationship:
- 2.5
- Justification:
- addressing the uncertainty related to the NOAEL used for DNEL derivation
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- Covered by calculation for route-to-route extrapolation
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
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:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 10
- Dose descriptor:
- NOAEC
- Value:
- 100 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- default assessment factor
- AF for differences in duration of exposure:
- 1
- Justification:
- default assessment factor for local effects
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- default assessment factor for local effects
- AF for other interspecies differences:
- 1
- Justification:
- default assessment factor for local effects
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
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:
- 10 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):
- 500
- Dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No long term dermal toxicity studies are available for propylene carbonate. However, data from other repeated dose toxicity studies could be used after extrapolation to the dermal route.
As discussed above in the Workers discussion section, the oral 90 days repeated dose toxicity study of Huntsman (1989) was observed to be the most sensitive study. The NOAEL of 5000 mg/kg bw/d was selected as starting point for the DNEL derivation for long-term exposure, systemic effects for the dermal route. The uncertainty related to using a higher NOAEL as starting dose is covered by an additional assessment factor of 2.5 for dose response relationship.
For route-to-route extrapolation (oral to dermal), no default factor (i. e. factor 1) should be applied as part of the overall assessment factor, as it is assumed that dermal absorption will not be higher than oral absorption (See toxicokinetic assessment in section 7.1 of the IUCLID file).
- AF for dose response relationship:
- 2.5
- Justification:
- addressing the uncertainty related to the NOAEL used for DNEL derivation
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat to human
- AF for other interspecies differences:
- 2.5
- Justification:
- rat to human
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
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:
- 10 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):
- 500
- Dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 5 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
As stated above, the oral 90 days repeated dose toxicity study of Huntsman (1989) was observed to be the most sensitive study and it is used to derive a DNEL long-term exposure, systemic effects, using a starting point of 5000 mg/kg bw/day.
- AF for dose response relationship:
- 2.5
- Justification:
- addressing the uncertainty related to the NOAEL used for DNEL derivation
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- human to rat
- AF for other interspecies differences:
- 2.5
- Justification:
- human to rat
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- default assessment factor
- AF for remaining uncertainties:
- 1
- Justification:
- default assessment factor
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
Long-term exposure, local effects, oral exposure:
- No local effects were observed in the Pharmakon Research International Inc. study (1989) after repeated oral exposure but this study is not relevant as route-to-route extrapolation is not applied for local effects according to ECHA Practical guide no 14 (2012). Therefore, it is not possible to derive a long-term exposure for local effects after oral exposure.
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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