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EC number: 201-873-2 | CAS number: 88-99-3
- 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:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Guideline Study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Principles of method if other than guideline:
- For reasons of animal welfare a sequential testing strategy was followed in accordance with the current version of the EEC Directive No. 440/2008 and the OECD Guideline No. 405, irrespective of the requirements of other guidelines for testing for eye irritation/corrosion in rabbits.
This testing strategy comprised a stepwise approach including the evaluation of existing human and/or animal data showing effects on the eye or the skin, the performance of a SAR evaluation for eye and skin corrosion/irritation, measurement of pH value, the evaluation of data on systemic toxicity via the dermal route, the performance of a validated in vitro test for skin corrosion (T 3081239, not corrosive), an in vitro test for skin irritation (T 2081238, not irritating) and an in vitro HET-CAM test for mucosal irritation hazard before in vivo testing for eye irritation/corrosion in rabbits.
The in vitro HET-CAM test is archived under T 5081240. The test compound is not irritating. - GLP compliance:
- yes
Test material
- Reference substance name:
- Phthalic acid
- EC Number:
- 201-873-2
- EC Name:
- Phthalic acid
- Cas Number:
- 88-99-3
- Molecular formula:
- C8H6O4
- IUPAC Name:
- benzene-1,2-dicarboxylic acid
- Details on test material:
- Molar mass: 166.13 g/mol, Content of test item*: 95 %, the dosing was based on the test item (used as 100%).
*due to product information given by the sponsor
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: The other eye, which remained untreated, served as control.
- Duration of treatment / exposure:
- 0.1 g of the pulverized test substance was placed into the conjunctival sac of one eye of the first animal after having gently pulled the lower lid away from the eyeball. The lids were gently held together for about one second in order to prevent loss of the test compound. The other eye, which remained untreated, served as control. The treated eye was rinsed 1 hour following instillation.
Because of the fact that one hour after treatment a severe irritation was observed in the first animal, only one further rabbit was treated as described. - Observation period (in vivo):
- Eye irritations were scored and recorded approximately at 1, 24, 48 and 72 hours post application (in the following p.a.). If no irritation indices were observed after 72 h, the study was finished. If eye irritations were observed, animals were monitored usually on day 7, 14 and 21 after application until the changes had completely subsided, however for not more than 21 days after application.
- Number of animals or in vitro replicates:
- Two animals were used for the study.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 3.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 14 d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0.5
- Max. score:
- 2
- Reversibility:
- fully reversible within: 3d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2.7
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 1
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 2
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7d
Any other information on results incl. tables
Summary of Irritant Effects (Score)
Animal | Effect | 24 h | 48 h | 72 h | Mean scores | Response | reversible (days) |
1 | corneal opacity | 4 | 3 | 3 | 3.3 | ++ | 14 |
iritis | * | 1 | 0 | 0.5 | - | 3 | |
redness conjunctivae | 2 | 3 | 3 | 2.7 | + | 7 | |
chemosis conjunctivae | 2 | 2 | 2 | 2.0 | + | 7 | |
2 | corneal opacity | 2 | 2 | 2 | 2.0 | + | 7 |
iritis | 1 | 1 | 1 | 1.0 | + | 7 | |
redness conjunctivae | 2 | 2 | 2 | 2.0 | - | 7 | |
chemosis conjunctivae | 3 | 2 | 1 | 2.0 | + | 7 |
response:
corneal opacity: mean scores < 2 = -, = 2 < 3 = +, = 3 = ++
iritis: mean scores < 1 = -, = 1 < 2 = +, = 2 = ++
conjunctival redness: mean scores < 2.5 = -, = 2.5 = +
conjunctival oedema : mean scores < 2 = -, = 2 = +
* Iris not observable, therefore not to investigate.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Executive summary:
The irritant / corrosive effects of the test substance were tested on the eye of female New Zealand White rabbits. The method used complied with the OECD - Guideline for Testing of Chemicals No. 405 -"Acute Eye Irritation/Corrosion"; adopted: 24th April 2002 and EEC Directive No. 440/2008 Part B - Method B.5. According to classification criteria the test substance causes serious damage to eyes with full reversibility within 14 days. There were no systemic intolerance reactions.
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