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EC number: 203-593-6 | CAS number: 108-55-4
- 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
- Study period:
- 1988
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 988
- Report date:
- 1988
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- Male or female New Zealand White rabbits are dosed with volumes of 0.1, 0.01 and 0.005 ml (liquid or solid). The dose is instilled into the lower conjunctival sac of one eye per animal or is placed directly on the eye. The eyelids are held together for one second. Six eyes are dosed per test volume. The eyes are scored accoridng to Draize scoring system at one hour, approximately 4 hours, one day, 2 days, 3 days and 7 days after dosing. Additional readings are made, if necessary, at 14 and 21 days. Fluorescein (2%) staining is used to determine corneal injury before dosing and at readings after one day.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Glutaric anhydride
- EC Number:
- 203-593-6
- EC Name:
- Glutaric anhydride
- Cas Number:
- 108-55-4
- Molecular formula:
- C5H6O3
- IUPAC Name:
- glutaric anhydride
- Test material form:
- solid: crystalline
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- no
- Duration of treatment / exposure:
- Dose applied directly to eyes. No indication of duration of exposure and no indication that eyes were washed after dosing. Thus it is not possible to accurately state the duration that the animals were exposed to the test substance.
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 6
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 1.7
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- 1.7
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 1.5
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 7 d
- Score:
- 0.3
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- 0.8
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 0.7
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 7 d
- Score:
- 0.5
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 2.2
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- 2.5
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 1.7
- Max. score:
- 2
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 7 d
- Score:
- 0.8
- Max. score:
- 2
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 14 d
- Score:
- 0.6
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 21 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 24 h
- Score:
- 2.7
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 48 h
- Score:
- 2.3
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 72 h
- Score:
- 1.5
- Max. score:
- 3
- Remarks on result:
- probability of moderate irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 7 d
- Score:
- 0.3
- Max. score:
- 1
- Remarks on result:
- probability of mild irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible within: 14 days
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Remarks:
- 6 animals
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 0
- Reversibility:
- fully reversible
- Remarks on result:
- no indication of irritation
Any other information on results incl. tables
Instillation of 10 mg of sample into rabbit eyes resulted in moderate to severe corneal injury (opacity) in 5 of 6 animals. One treated eye had no corneal effects. Iritis was apparent in 6 eyes and moderate to severe conjunctival irritation developed in 6 rabbits. After 48 hours, all rabbits exhibited a pus-like ocular discharge. Two eyes had a normal appearance after 7 days. Corneal vascularization developed in one rabbit and another animal exhibited a hemorrhaged nictitating membrane. One animal died at 12 days. The treated eye of this animal had completely healed by 7 days. The death was not considered to be related to the treatment. By 14 days, 2 of the remaining 5 eyes had a normal appearance. Two others only had minor conjunctival irritation. All eyes were healed after 21 days.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- The test substance appears to have caused severe damage to the eyes that persisted through the first 72 hours after dosing. All lesions subsequently heald over the course of the observation period with no damage present at day 21. Due to the severity of the initial lesions and their persistance for more than 24 hours, this test material meets the criteria for classification as an eye irritant that may cause serious damage to the eyes.
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