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Diss Factsheets
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EC number: 207-997-3 | CAS number: 504-63-2
- 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
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- test procedure in accordance with generally accepted scientific standards and described in sufficient detail
- Remarks:
- PDO from chemical process.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 997
- Report date:
- 1997
Materials and methods
Test guideline
- Qualifier:
- no guideline followed
- Principles of method if other than guideline:
- Six male rats were exposed nose-only for a single 4-hour period to 1,3-propanediol aerosol in air. Rats were weighed and observed for clinical signs of toxicity during a 14-day observation period.
- GLP compliance:
- no
- Test type:
- other: Inhalation Approximate Lethal Concentration
Test material
- Reference substance name:
- Propane-1,3-diol
- EC Number:
- 207-997-3
- EC Name:
- Propane-1,3-diol
- Cas Number:
- 504-63-2
- Molecular formula:
- C3H8O2
- IUPAC Name:
- propane-1,3-diol
- Details on test material:
- - Physical state: liquid
- Purity: >99%
- Stability under test conditions: The test substance was expected to be stable throughout the exposure phase of the study.
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Crl:CD(SD)BR
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Breeding Laboratories, Raleigh, North Carolina
- Age at study initiation: approximately 8 weeks
- Weight at study initiation: 239 to 307 grams
- Housing: Housed either singly or in pairs in suspended, stainless steel, wire-mesh cages
- Diet: Certified Rodent Chow #5002, ad libitum
- Water: Tap water from United Water Delaware, ad libitum
- Acclimation period: Rats were quarantined after arrival for at least 6 days prior to testing.
ENVIROMENTAL CONDITIONS
- Temperature (°C): 23±2
- Humidity (%): 50±10
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): 12-hour light/12-hour dark.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: air
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: Spraying Systems Nebulizer with a Harvard Model 22 Syringe Infusion Pump.
- Exposure chamber volume: 29-L
- Method of holding animals in test chamber: Individually restrained in perforated stainless steel cylinders with conical nose pieces
- Source and rate of air: Filtered Houseline Air and 15 L/min
- Method of conditioning air: chamber airflow was set at the beginning of each exposure and adjusted to maintain desired atmospheric concentration. Airflow was monitored continually with a Brooks model 1355 Sho-Rate Rotometer. Temperature, relative humidity, and oxygen were measured two times during the exposure.
- System of generating particulates/aerosols: Polycarbonate dispersion plate located near the chamber inlet was used to promote uniform aerosol distribution throughout the chamber.
- Method of particle size determination: Gravimetric Analysis (preweighed 25 mm Gelman glass fiber Type A/E filter. Weighed on a Cahn model C-30 Microbalance
- Treatment of exhaust air: Pair of liquid traps (water scrubbers) and MSA charcoal/HEPA filter cartridge
- Temperature, humidity, pressure in air chamber: 23±2°C, 48 to 54%
TEST ATMOSPHERE
- Brief description of analytical method used: Aerosol concentrations determined at 30-minute intervals by gravimetric analysis. Once air sample collected during exposure to determine particle size distribution with a Sierra Series 210 cyclone preseparator/cascade impactor and Sierra Series 110 Constant Flow Air Sampler.
- Samples taken from breathing zone: Yes. Known air volumes drawn from breathing zone through a filter cassette that contained a preweighed 25 mm Gelman glass fiber filter.
- MMAD (Mass median aerodynamic diameter) / GSD (Geometric st. dev.): MMAD = 3.2 µm GSD 2.1 - Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- 5 mg/L
- No. of animals per sex per dose:
- 6 male rats
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: Observed each day for mortality, and were weighted and observed for clinical signs of toxicity at least four times per week (weekends excluded unless warranted by the health status of the rats).
- Necropsy of survivors performed: no
Results and discussion
Effect levels
- Sex:
- male
- Dose descriptor:
- other: ALC
- Effect level:
- > 5 mg/L air (analytical)
- Exp. duration:
- 4 h
- Mortality:
- There were no mortalities for rats exposed to 5.0 mg/L.
- Clinical signs:
- other: During the exposure, no abnormal clinical signs were observed. Immediately following the exposure, when rats were removed from the chamber, all rats had wet fur/perineum, and one rat had an ocular discharge. No clinical signs of toxicity were observed i
- Body weight:
- Slight to moderate weight loss was observed in all rats one day following the exposure. Although one rat had transient body-weight loss during the remainder of the recovery, all rats experienced an overall weight gain by the end of the 14-day recovery period.
Any other information on results incl. tables
Mean Aerosol Concentration (mg/L) |
Aerosol Size |
Mortality |
||
MMAD (µm) |
Geometric Standard Deviation |
Percent < 10µm |
||
5.0 |
3.2 |
2.1 |
94 |
0/6 |
Applicant's summary and conclusion
- Conclusions:
- The study and the conclusions which are drawn from it fulfill the quality criteria (validity, reliability, repeatability).
- Executive summary:
Six male rats were exposed nose-only for a single 4-hour period to 1,3-propanediol aerosol in air. Rats were weighed and observed for clinical signs of toxicity during a 14-day recovery period. The approximate lethal concentration (ALC) was greater than 5.0 mg/L.
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