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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
- Remarks:
- PDO from chemical process.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- not specified
- Remarks:
- Housing and Feeding Conditions
- GLP compliance:
- not specified
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:
- - Name of test material (as cited in study report): Propanediol-1,3
- Purity: Not reported
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Age at study initiation: Not reported
- Weight at study initiation: Not reported
- Housing: Caged individually and received no hay or other extraneous material that might enter the eyes.
- Diet (e.g. ad libitum): Not reported
- Water (e.g. ad libitum): Not reported
- Acclimation period: Not reported. The eyes of animals were examined before testing and only those animals without observable eye defects were used.
ENVIRONMENTAL CONDITIONS
- Temperature (°C): Not reported
- Humidity (%): Not reported
- Air changes (per hr): Not reported
- Photoperiod (hrs dark / hrs light): Not reported
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye served as the control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1 mL
- Duration of treatment / exposure:
- The upper and lower eye lid were carefully closed and held together for 1 second. The other eye, remaining untreated, served as the control.
- Observation period (in vivo):
- The eyes were examined at 24, 48, 72 hours and 7 days after instillation of the test material.
- Number of animals or in vitro replicates:
- 6 New Zealand White albino rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): Washing was not done.
- Time after start of exposure: The eyes were examined at 24, 48, 72 hours and 7 days after instillation of the test material.
SCORING SYSTEM: FDA-scoring scale
TOOL USED TO ASSESS SCORE: Binocular magnifying glass
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no additional readings reported after 48 hours (all scores were 0 at 48 hours)
- Irritation parameter:
- iris score
- Basis:
- animal: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 2
- Remarks on result:
- other: no additional readings reported after 48 hours (all scores were 0 at 48 hours)
- Irritation parameter:
- chemosis score
- Basis:
- animal: all animals
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: no additional readings reported after 48 hours (all scores were 0 at 48 hours)
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all animals
- Time point:
- 24 h
- Score:
- >= 0 - <= 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: score of 1 was observed in 4 animals and score of 0 was observed in 2 animals
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all animals
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: all animals
- Time point:
- 72 h
- Remarks on result:
- other: no additional readings reported after 48 hours (all scores were 0 at 48 hours)
- Irritant / corrosive response data:
- The ocular effects of propanediol-1,3 consisted of slight redness of the conjunctivae in four out of six rabbits.
Any other information on results incl. tables
Animal Number |
Cornea |
Iris |
Conjunctivae |
|
Redness |
Chemosis |
|||
After 24 Hours |
||||
1 |
0 |
0 |
1 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
1 |
0 |
4 |
0 |
0 |
1 |
0 |
5 |
0 |
0 |
1 |
0 |
6 |
0 |
0 |
0 |
0 |
After 48 Hours |
||||
1 |
0 |
0 |
0 |
0 |
2 |
0 |
0 |
0 |
0 |
3 |
0 |
0 |
0 |
0 |
4 |
0 |
0 |
0 |
0 |
5 |
0 |
0 |
0 |
0 |
6 |
0 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The ocular effects of propanediol-1,3 consisted of slight redness of the conjunctivae in four out of six rabbits. After 48 hours these effects had cleared up.
- Executive summary:
The test substance (0.1 mL) was allowed to fall on the everted lower lid on one eye of each rabbit. The upper and lower eye lid were carefully closed and held together for 1 second. The other eye, remaining untreated, served as the control. The test substance was not washed from the eyes. The eyes were examined at 24, 48, 72 hours and 7 days after instillation of the test material.
The ocular effects of propanediol-1,3 consisted of slight redness of the conjunctivae in four out of six rabbits. After 48 hours these effects had cleared up.
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.