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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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (non-LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 4 (not assignable)
- Rationale for reliability incl. deficiencies:
- other: Only summary data provided with limited information on methods and results.
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- publication
- Title:
- Final report on the safety assessment of propylene carbonate
- Author:
- Beyer KH Jr., Bergfeld WF, Berndt, WO, et al.
- Year:
- 1 987
- Bibliographic source:
- Journal of the American College of Toxicology Vol 6, (1)
Materials and methods
- Principles of method if other than guideline:
- Schwartz and Peck ( 1944. Pub Health Rep 59:, 546-557)
- GLP compliance:
- not specified
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): Eye care products containing between 1.51 and 1.98% Propylene carbonate
In vivo test system
Test animals
- Species:
- human
- Sex:
- not specified
Study design: in vivo (non-LLNA)
Induction
- Route:
- other: closed and open patch
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Three eye area products containing between 1.51% and 1.98% test substance was tested.
Challenge
- Route:
- other: closed and open patch
- Vehicle:
- unchanged (no vehicle)
- Concentration / amount:
- Three eye area products containing between 1.51% and 1.98% test substance was tested.
- No. of animals per dose:
- 304 subjects total
- Details on study design:
-
MAIN STUDY
A. INDUCTION EXPOSURE
- No. of exposures: single
- Exposure period: 48 hours
B. CHALLENGE EXPOSURE
- No. of exposures: single
- Exposure period: 48 hours
OTHER : 10-14 day nontreatment period following induction and the start of the challenge exposure.
The closed patch sites were irradiated with ultraviolet (UV) light following both induction and challenge gradings. The light source consisted of a Spectronics B-100 broad spectrum lamp, which included in its spectrum a wavelength of 365 nm. The lamp was held 12 inches from the skin for 1 minute.
Results and discussion
In vivo (non-LLNA)
Results
- Reading:
- other: all
- Hours after challenge:
- 48
- Group:
- test chemical
- Dose level:
- between 1.51% and 1.98%
- No. with + reactions:
- 0
- Total no. in group:
- 304
- Remarks on result:
- other:
- Remarks:
- 2 subjects had weak, nonvesicular reactions to the closed patch. Four developed skin reactions to the UV light. No reactions to the open challenge patches were observed.
Any other information on results incl. tables
Induction results: Of the 304 subjects, 9 had weak (nonvesicular) reactions and 1 had an extreme (bullous or ulcerative) reaction to the closed patch. No reactions were observed as a result of the open induction patch or as a result of UV exposure.
Challenge results: Of the 304 subjects, 2 had weak, nonvesicular reactions to the closed patch, whereas 4 developed skin reactions to the UV light; no reactions to the open challenge patches were observed.
It was not ascertained whether the few positive reactions to the exaggerated closed patch conditions and to the UV light were due to the test substance or other ingredients in the product.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The three eye care products were considered to be nonirritating, nonsensitizing, and nonphtotosensitizing under conditions of the test.
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