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EC number: 201-607-5 | CAS number: 85-44-9
- 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
- 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:
- other: Observation time 7 days, short documentation, low dose 50 mg
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 979
- Report date:
- 1979
Materials and methods
- Principles of method if other than guideline:
- 1 male and 1 female New Zealand white rabbit, 50 mg/rabbit was applied into the conjunctival sac of one eye of each rabbit, observation time: 7 days, evaluation according Draize
- GLP compliance:
- no
Test material
- Reference substance name:
- Phthalic anhydride
- EC Number:
- 201-607-5
- EC Name:
- Phthalic anhydride
- Cas Number:
- 85-44-9
- Molecular formula:
- C8H4O3
- IUPAC Name:
- 1,3-dihydro-2-benzofuran-1,3-dione
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- White New Zealand rabbits, weight 3-4 kg
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- not required
- Amount / concentration applied:
- Amount: 50 mg
- Duration of treatment / exposure:
- 7 days
- Observation period (in vivo):
- 7 days
- Number of animals or in vitro replicates:
- 2
- Details on study design:
- No further data
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- ca. 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 1
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0.5
- Max. score:
- 4
- Reversibility:
- not specified
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 4
- Reversibility:
- not specified
- Remarks on result:
- other: not measured/tested
- Remarks:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- >= 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- >= 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- not measured/tested
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 2
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- not measured/tested
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 1.5
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- not fully reversible within: 7 days
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 72 h
- Score:
- >= 0
- Max. score:
- 3
- Reversibility:
- not specified
- Remarks on result:
- other:
- Remarks:
- not measured/tested
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 72 h
- Remarks on result:
- not measured/tested
- Other effects:
- no data
Any other information on results incl. tables
Scores:
rabbit1 - rabbit2
cornea (maximal score 4):
1h: 1 - 1
24h: 1 - 1
day 2: 1 - 0
day 7: 0 - 0
transitional slight cloudiness of the cornea
Iris (maximal score: 2):
1h: 1 - 1
24 h and later: 0 - 0
conjunctiva, redness (maximal score 3):
1h: 2 - 2
24h: 1 - 2
day 2: 1 - 1
day 7: 1 - 1
conjunctiva, swelling (maximal score 4):
1h: 2 - 1
24 h and later: 0 - 0
lacrimation:
1h: 1 - 1
24 h and later day 14: 0 - 0
The cornea was temporary cloudy. The observed effects were not fully
reversible during the 7 days observation period.
Applicant's summary and conclusion
- Interpretation of results:
- Category 1 (irreversible effects on the eye) based on GHS criteria
- Executive summary:
Method: 2 animals received a dose of 50 mg/animal in the conjunctival sac, postexposure period 7 days.
Result: Not fully reversible within 7 days, cornea temorarily in parts opaque.
Reference: Thyssen/Bayer AG (1979)
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