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EC number: 692-561-9 | CAS number: 19444-84-9
- 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
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- Endpoint summary
- Stability
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- 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:
- supporting study
- Study period:
- January 2012
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Eye irritation was determined according to OECD Guideline 405 (Acute eye iiritation/corrosive).
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-hydroxyoxolan-2-one
- EC Number:
- 692-561-9
- Cas Number:
- 19444-84-9
- Molecular formula:
- C4H6O3
- IUPAC Name:
- 3-hydroxyoxolan-2-one
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- ANIMALS
-Number: three males.
-Strain and species: New Zealand White rabbits.
-Reason for selection of species: rabbit is a non-rodent species accepted by regulatory authorities for this type of study.
-Breeder: Hypharm, La Corbière, Roussay, France.
-Age/weight: at the beginning of the study, the animals were 2 to 4 months old and had a mean body weight ± standard deviation of 2872 g (2821 g to 2959 g).
-Receipt: upon arrival at CIT, the animals were given a clinical examination to ensure that they are in good condition.
-Acclimation: the animals were acclimated for a period of at least 5 days before treatment of the dermal irritation study (CIT/Study No. 38035 TAL). As the animals were remained in the same study conditions, nobfurther acclimation period was necessary before the present study.
-Selection: just before treatment, the eyes of each animal were examined in order to use only animals without any signs of ocular irritation or lesions.
-Identification: the animals were individually identified with a metal ear-tag.
The conditions in the animal room were set as follows:
-temperature : 18 ± 3°C,
-relative humidity : 50 ± 20%,
-light/dark cycle : 12 h/12 h (7:00 - 19:00),
-ventilation : approximately 12 cycles/hour of filtered, non-recycled air.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The right eye remained untreated and served as control.
- Amount / concentration applied:
- The test item was administered in the conjunctival sac of the left eye after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the test item.
The right eye remained untreated and served as control.
A dosage-volume of 0.1 mL/animal was used. - Duration of treatment / exposure:
- The eyes were not rinsed before 24-hour reading.
- Observation period (in vivo):
- 1 hour, 24, 48 and 72 hours after administration of the test item
- Number of animals or in vitro replicates:
- 3 Males
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- >= 0 - <= 2.3
- Max. score:
- 2.3
- Reversibility:
- fully reversible
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- >= 0 - <= 1
- Max. score:
- 1
- Reversibility:
- fully reversible
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- >= 0.3 - <= 2.3
- Max. score:
- 2.3
- Reversibility:
- fully reversible
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- other: 24, 48 and 72 hours
- Score:
- >= 0 - <= 2.3
- Max. score:
- 2.3
- Reversibility:
- fully reversible
- Irritant / corrosive response data:
- No unscheduled deaths occurred during the study.
No clinical signs were noted in any animals.
No ocular reactions were observed in the right untreated control eye.
Mean scores calculated for each animal over 24, 48 and 72 hours were as follows:
. chemosis: 0.0, 1.0 and 2.3; showing eye irritation in the third animal,
. redness of the conjunctiva: 0.3, 1.3 and 2.3; showing eye irritation in the third animal,
. iris lesions: 0.0, 0.0 and 1.0; showing no significant eye irritation,
. corneal opacity: 0.0, 0.0 and 1.7; showing no significant eye irritation.
Applicant's summary and conclusion
- Interpretation of results:
- slightly irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, the test item, 2-Hydroxy Gamma Butyro Lactone, was slightly irritant when administered by ocular route to rabbits.
However, the test item is not classified as irritating to the eye according to the criteria of CLP Regulation.
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