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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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2000-08-08 to 2000-08-25
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 001
- Report date:
- 2001
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
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): ULTRAPURE propylene carbonate
- Physical state: clear liquid
- Analytical purity: 100%
- Lot/batch No.: 9L610
- Storage condition of test material: ambient temperature in the dark
- Stability under test conditions: responsibility of the Sponsor
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River UK Limited, Margate, Kent, UK.
- Age at study initiation: young adults
- Weight at study initiation: 3553-4142 g
- Housing: individually, in cages suitable for animals of this strain and the weight range expected during the course of the study
- Diet (e.g. ad libitum): Diet (STANRAB SQC),ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: min.5d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 18°C±3°C
- Humidity (%): 30-70%
- Air changes (per hr): min of 15 changes/hour
- Photoperiod (hrs dark / hrs light): 12h light ,12h dark
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent no treatment
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.1mL - Duration of treatment / exposure:
- 1-2sec.
- Observation period (in vivo):
- 10 days
- Number of animals or in vitro replicates:
- 3M
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no data
- Time after start of exposure: no data
SCORING SYSTEM:
Draize scale to assess the grade of ocular reaction
Kay and Calandra system
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 80
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 1d
- Score:
- 8.3
- Max. score:
- 80
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 2d
- Score:
- 3.3
- Max. score:
- 80
- Reversibility:
- fully reversible within: 3 days
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1h
- Score:
- 0
- Max. score:
- 10
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 1d
- Score:
- 1.7
- Max. score:
- 10
- Reversibility:
- fully reversible within: 2 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 1h and 1d
- Score:
- 13.3
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 2d
- Score:
- 10
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 3d
- Score:
- 4.7
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 4d
- Score:
- 3.3
- Max. score:
- 20
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 7d
- Score:
- 1
- Max. score:
- 20
- Reversibility:
- fully reversible within: 10 days
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- other: day1
- Score:
- 23.3
- Max. score:
- 110
- Irritation parameter:
- other: Final irritation score
- Basis:
- mean
- Time point:
- other: 7d
- Score:
- 5
- Max. score:
- 8
- Reversibility:
- not specified
- Remarks on result:
- other: moderate irritant
- Irritant / corrosive response data:
- Observation:
-slight corneal opacity observed in 2/3 animals for up to 2 days
-slight iritis was seen in 1/3 animal for 1 day after instillation.
-conjunctival effects were seen in 3/3 animals for up to 7 days (slight or moderate redness, slight or mild chemosis and a moderate or severe discharge). - Other effects:
- Observation: additional signs of irritation consisted of Harderian or mucoid discharge, erythematous or thickened eyelids, haemorrhage of the nictitating membrane and dried secretion around the periorbital skin were observed.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes)
- Conclusions:
- ULTRAPURE propylene carbonate is a moderate irritant (class 5 on a 1-8 scale) to the rabbit eye. According to the criteria laid down in the CLP Regulation (EC) 1272/2008, propylene carbonate is classified as an eye irritant substance category 2 (irritating to eyes) as the mean redness score is 2 at 24, 48 and 72 hours in 2 of the 3 animals tested and the effects are fully reversible within 10 days.
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