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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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- sub-chronic toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1989-02-20 to 1989-05-25
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 991
- Report date:
- 1991
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 413 (Subchronic Inhalation Toxicity: 90-Day Study)
- GLP compliance:
- yes (incl. QA statement)
- Limit test:
- no
Test material
- Reference substance name:
- Propylene carbonate
- EC Number:
- 203-572-1
- EC Name:
- Propylene carbonate
- Cas Number:
- 108-32-7
- Molecular formula:
- C4H6O3
- IUPAC Name:
- 4-methyl-1,3-dioxolan-2-one
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- - Name of test material (as cited in study report): propylene carbonate (TEXACAR PC)
- Analytical purity: at least 99.9%
- Storage condition of test material: Chemical storage room blanketed with nitrogen
- Lot/batch No.: 9A-502
- Other: Source- Texaco Chemical Company, Austin, Texas
Test animals
- Species:
- rat
- Strain:
- Fischer 344
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Harlan Sprague-Dawley, Inc., Fredrick, MD
- Age at study initiation: 61 days
- Housing: 1-3 per cage, same sex, during non exposure period, individual during exposure, 15 x 22 x 18 cm wire mesh cages
- Diet: Agway Pro Lab powdered food, ad libitum
- Water: Water ad libitum via automatic watering system
- Acclimation period: 2 -3 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): monitored continuously.
- Humidity (%): monitored continuously.
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12 hour light/dark photoperiod throughout the study.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- whole body
- Vehicle:
- other: unchanged (no vehicle)
- Remarks on MMAD:
- MMAD / GSD: The MMAD for the 100, 500 and 1000 mg/m³ concentrations were 5.32, 4.62, and 4.72 microns, respectively, with a geometric standard deviation of 2.74, 2.52 and 2.32, respectively.
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Inhalation chamber
- Method of holding animals in test chamber: wire mesh cage
- Source and rate of air: Filtered forced air
- System of generating particulates/aerosols: The test substance was metered from a piston pump into an atomizer fitted withe a liquid nozzle and and air nozzle. The atomizer was inserted into the top of the inhalation turret where the liquid aerosols were dispersed by the filtered chamber supply air.
- Air flow rate: 300 L/min
- Air change rate: 13.5 changes/hr
- Method of particle size determination: Cascade impactor. Measurements made twice a week for each concentration.
TEST ATMOSPHERE
- Brief description of analytical method used: A 25 minute sample was taken from each chamber each day isng a vacuum pump dry gas meter or flow meter.
- Samples taken from breathing zone: no
- Analytical verification of doses or concentrations:
- no
- Duration of treatment / exposure:
- 6 hours/day, 5 days/week, 13 weeks (93 days)
- Frequency of treatment:
- daily
Doses / concentrationsopen allclose all
- Dose / conc.:
- 0 mg/m³ air (nominal)
- Remarks:
- control group
- Dose / conc.:
- 100 mg/m³ air (nominal)
- Dose / conc.:
- 500 mg/m³ air (nominal)
- Dose / conc.:
- 1 000 mg/m³ air (nominal)
- No. of animals per sex per dose:
- 15 males, 15 females
- Control animals:
- yes, sham-exposed
- Details on study design:
- - Rationale for selecting satellite groups: A satellite group of 10 rats per sex/dose was assigned to each group for acute neurotoxicity testing
- Positive control:
- None
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No
DETAILED CLINICAL OBSERVATIONS: no
BODY WEIGHT: Yes- prior to test initiation for group assignment
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: Yes
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No
WATER CONSUMPTION: No
OPHTHALMOSCOPIC EXAMINATION: Yes
- Time schedule for examinations: Prior to exposure and on May 17, 1989.
- Dose groups that were examined:All rats
HAEMATOLOGY: Yes
- Time schedule for collection of blood: Week 5 and 14
- Anaesthetic used for blood collection: Yes (methoxyflurane)
- Animals fasted: Yes
- How many animals: 10/sex/group
-20 blood chemistry analyses performed
CLINICAL CHEMISTRY: Yes -see above
URINALYSIS: Yes
- Time schedule for collection of urine: 15 hours from 10/sex/group prior to sacrifice
- Metabolism cages used for collection of urine: Yes
- Animals fasted: No
NEUROBEHAVIOURAL EXAMINATION: Yes
- Time schedule for examinations: 1 and 13 hrs, 6 weeks, 13 weeks
- Dose groups that were examined: Satellite group, 10/sex/dose
- Battery of functions tested: motor activity
- Statistics:
- Standard analyses were used, including Levene's test for equal variance, ANOVA, and t-tests. Fisher's exact test was used for the microscopy. The limit of 0.05 was used as the critical level of significance in all tests.
Results and discussion
Results of examinations
- Clinical signs:
- effects observed, treatment-related
- Description (incidence and severity):
- The only clinical sign believed to be exposure related was periocular swelling observed in 13-33% of male animals in the propylene carbonate exposure groups. Female animals were also observed to have periocular swelling, however, this finding was observed at a high frequency in the control group making the significance of the observation in the exposure groups dubious.
At the end of the exposure regimen, there were no exposure related lesions observed in any animal. - Mortality:
- no mortality observed
- Body weight and weight changes:
- no effects observed
- Description (incidence and severity):
- No effects on body weight or body weight gain.
- Food consumption and compound intake (if feeding study):
- effects observed, treatment-related
- Description (incidence and severity):
- No treatment related effects in females. A statistically significant increase in food consumption was noted in week 2 of exposure in the 500 and 1000 mg/m³ males.
- Food efficiency:
- not examined
- Water consumption and compound intake (if drinking water study):
- no effects observed
- Description (incidence and severity):
- No treatment related effects
- Ophthalmological findings:
- effects observed, treatment-related
- Haematological findings:
- no effects observed
- Description (incidence and severity):
- No treatment related effects.
- Clinical biochemistry findings:
- no effects observed
- Description (incidence and severity):
- No treatment related effects.
- Urinalysis findings:
- no effects observed
- Description (incidence and severity):
- No treatment related effects.
- Behaviour (functional findings):
- no effects observed
- Description (incidence and severity):
- No treatment related effects.
- Immunological findings:
- not examined
- Organ weight findings including organ / body weight ratios:
- no effects observed
- Description (incidence and severity):
- No test substance related effects.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- The only gross lesion was swollen periocular tissue in one 500 mg/m³ animal and two animals in the 1000 mg/m³ animals.
- Neuropathological findings:
- not examined
- Histopathological findings: non-neoplastic:
- no effects observed
- Description (incidence and severity):
- No microscopic lesions were attributed to propylene carbonate treatment.
- Histopathological findings: neoplastic:
- not examined
- Other effects:
- not specified
Effect levels
open allclose all
- Dose descriptor:
- NOAEC
- Remarks:
- systemic
- Effect level:
- 1 000 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- ophthalmological examination
- other: No systemic adverse effects were observed.
- Dose descriptor:
- NOAEC
- Remarks:
- local
- Effect level:
- 100 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: ophthalmoscopic examination: swollen periocular tissue was observed in 2 animals of the 500 mg/m³ group and four animals of the 1000 mg/m³
- Dose descriptor:
- LOAEC
- Remarks:
- local
- Effect level:
- 500 mg/m³ air (nominal)
- Based on:
- test mat.
- Sex:
- male/female
- Basis for effect level:
- other: ophthalmoscopic examination: swollen periocular tissue was observed in 2 animals of the 500 mg/m³ group and four animals of the 1000 mg/m³
Target system / organ toxicity
- Critical effects observed:
- no
Applicant's summary and conclusion
- Conclusions:
- Repeated exposure to propylene carbonate in rats at concentrations up to 1000 mg/m3 produced only signs of minimal irritation to the eyes in rats. Therefore the NOAEC (systemic effects) is considered to be 1000 mg/m3, the highest dose tested.
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