Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
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
Dermal absorption
Administrative data
- Endpoint:
- dermal absorption in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Remarks:
- PDO from biological process.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
- Report date:
- 2006
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 428 (Skin Absorption: In Vitro Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guidance Document for the Conduct of Skin Absorption Studies. OECD Environmental Health and Safety Publication Series on Testing and Assessment No. 28. (2004)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- other: European Commission Guidance Document on Dermal Absorption. Sanco/222/2000 rev 7 (2004)
- Deviations:
- no
- GLP compliance:
- yes
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:
- - Purity: 99.953%
Constituent 1
- Radiolabelling:
- no
Test animals
- Species:
- other: in vitro (human skin)
- Details on test animals or test system and environmental conditions:
- Samples of human cadaver skin obtained from the abdominal region were obtained from the National Disease Research Interchange (NDRI, Philadelphia, PA), and were stored frozen at approximately -20°C until prepared for use. Samples were collected from donors within 24 hours of death.
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- not specified
- Duration of exposure:
- Exposure was terminated following steady-state determination.
- Doses:
- Dose volume: 1200 μL/cm2
Density: 1,059,700 ug/cm3 - No. of animals per group:
- 6 representing 3 donors
- Details on study design:
- SKIN PREPARATION
- Preparative technique: Full thickness skin was immersed in 60°C water for 45 seconds to 2 minutes and the epidermis peeled away from the dermis.
- Membrane integrity check: Skin integrity was confirmed by electrical impedance following system equilibration.
- Storage conditions: Samples were stored frozen at approximately -20°C until prepared for use.
PRINCIPLES OF ASSAY
- Diffusion cell: The in vitro cells had an exposure area of 0.64 cm2, and a receptor fluid chamber volume of approximately 5 ml, which was continuously stirred throughout the exposure interval using a magnetic stir bar.
- Receptor fluid: 0.9% saline
- Static system: Static diffuse cell model with an exposure area of 0.64 cm square.
- Test temperature: Receptor fluid temperature of 32°C.
- Occlusion: Following dose application, the donor chamber opening was occluded with Parafilm®. The receptor chamber arm remained occluded with Parafilm® at all times other than at sampling.
- Sampling and analysis: Serial receptor fluid samples were taken at 0, 4, 8, 12, 18, 24, 30, 36, 42 and 48 hours post-application and analyzed by GC/FID.
Steady state penetration was determined by plotting the cumulative amount of test substance detected in the receptor fluid at each sampling point, adjusted for total receptor fluid volume, against time to produce an absorption profile. Kp was calculated by dividing the penetration rate or slope of the line at steady-state represented by at least 4 data points, by the concentration of applied chemical.
Results and discussion
- Total recovery:
- At the end of the 48 hour exposure interval, 0.12% of the applied chemical was detected in the receptor chamber.
Any other information on results incl. tables
The test substance was detected in the receptor fluid at the 4 hour serial sampling timepoint (74.6 μg/cm2). The final receptor fluid sample (48 hour) was 1481.5 μg/cm2.
Steady state penetration of the test substance, which was represented by a minimum of 4 data points, had a slope of 15.9 μg/cm2/h.
At the end of the 48-hour period exposure interval, 0.12% of the applied test substance was detected in the receptor chamber demonstrating that the static diffusion cell receptor fluid (0.9% saline) offered sink conditions to the test substance.
The permeability coefficient was calculated to be 1.50e-5 cm/h, based on the slope at steady state (15.9 μg/cm2/h) and the concentration of the test substance in the applied formulation taken as its density (1,059,700 μg/cm3).
Applicant's summary and conclusion
- Conclusions:
- The permeability coefficient was calculated to be 1.50e-5 cm per hour based on the slope at the steady-state (15.9 µg/cm square per hour) and the concentration of applied dose of test substance taken as its density (1,059,700 µg/cm3).
- Executive summary:
The permeability coefficient (Kp) was determined using human abdominal skin from cadavers mounted in an in vitro static diffusion cell model. Human cadaver skin was heat treated at approximately 60°C and the epidermis was peeled from the dermis and the section mounted onto an in vitro diffusion cell, stratum corneum uppermost, with an exposure area of 0.64 cm2. Using a recirculating water bath system, the receptor fluid (0.9 % saline) was set at 32°C. Following system equilibration, skin integrity was confirmed by electrical impedance. The saline in the donor and receptor chambers was removed and discarded and the receptor chamber was filled with fresh 0.9% saline.
An infinite dose of the test substance was applied to the epidermal surface, via the donor chamber, at a target range of 1200 µL/cm2, to 6 skin replicates representing 3 human subjects, and the donor chamber opening was occluded with a Parafilm®. Serial receptor fluid samples were taken at 0, 4, 8, 12, 18, 24, 30, 36, 42, and 48 hours post-application and analyzed by GC/FID.
Based on the slope at steady-state (15.9 µg/cm2/h) and the concentration of the applied dose of the test substance taken as its density (1,059,700 µg/cm3), the permeability coefficient was calculated to be 1.50x10e-5 cm/h.
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.