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EC number: 700-251-2 | CAS number: 72684-95-8
- 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:
- 2008-12-15 to 2008-12-18
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EPA OPPTS 870.2400 (Acute Eye Irritation)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4-hydroxy-3,5-dimethoxybenzonitrile
- Cas Number:
- 72684-95-8
- IUPAC Name:
- 4-hydroxy-3,5-dimethoxybenzonitrile
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- - Composition of test material, percentage of components: syringonitrile 99.8%
- Expiration date of the lot/batch: May 2010
-Physical description: pale yellow powder
-solubility: soluble in water
-stability: test substance was expected to be stable for the duration of the testing.
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Received from Robinson Services, Inc, Clemmons, NC, on Dec. 10, 2008
- Age at study initiation: young adult
- Housing: singly housed in suspended stainless steel cage
- Diet (e.g. ad libitum): pelleted Purina Rabbit Chow
- Water (e.g. ad libitum): filtered tap water was supplied ad libitum by an automatic water dispensing system.
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19-21°C
- Humidity (%): 38-44%
- Photoperiod (hrs dark / hrs light): 12 hr light/dark cycle
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes
- Amount / concentration applied:
- One-tenth of a mililiter (0.06 grams) of the test substance was instilled to the right eye.
- Duration of treatment / exposure:
- After the instillation, the upper and lower lids were gently held together for about one second before releasing to minimize loss of the test substance.
- Observation period (in vivo):
- 72 hrs
- Number of animals or in vitro replicates:
- 3 female rabbits
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
-At the 24-hour scoring period, one drop of 2% ophthalmic fluorescein sodium was instilled into both eyes of each rabbit and the eyes were rinsed with physiological saline and then evaluated for corneal opacity with an UV-light.
SCORING SYSTEM:
Kay and Calandra scheme for classifying eye irritants
Ocular irritation evaluated in accordance with Draize et al.
TOOL USED TO ASSESS SCORE: Ocular irritation was evaluated using a high-intensity white light (Mag Lite). Corneal opacity evaluated with an UV-light.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- maximum mean total score (MMTS)
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 17
- Max. score:
- 17
- Remarks on result:
- other: includes score for 1-hour reading
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: includes score for 1-hour reading
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: score of 1 for 1-hour reading
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: score of 1 for 1-hour reading
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: score of 1 for 1-hour reading
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: score of 1 for 1-hour reading
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: score of 1 for 1-hour reading
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 2
- Reversibility:
- fully reversible within: 72 hours
- Remarks on result:
- other: score of 2 for 1-hour reading
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: score of 2 for 1-hour reading
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- >= 0 - <= 1
- Reversibility:
- fully reversible within: 48 hours
- Remarks on result:
- other: score of 1 for 1-hour reading
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: score of 1 for 1-hour reading
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: score of 1 for 1-hour reading
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- other: score of 0 for 1-hour reading
- Irritant / corrosive response data:
- One hour after the instillation, two treated eyes exhibited corneal opacity and all three treated eyes exhibited iritis and conjunctivitis. The overall incidence and severity of irritation decreased gradually with time. All animals were free of ocular irritation within 72 hrs.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- Under the conditions of this study, the test substance is mildly irritating to the eye.
- Executive summary:
The objective of this study was to assess the ocular irritation potential of Mediator SNP (4-hydroxy-3,5-dimethoxybenzonitrile). One-tenth of a milliliter (0.1 mL) of Mediator SNP was instilled into the right eye of three rabbits. The left eye remained untreated and served as control. Ocular irritation was evaluated using a high-intensity white light (Mag Lite) at 1, 24, 48 and 72 hours post-instillation. At the 24-hour scoring period, one drop of 2% ophthalmic fluorescein sodium was instilled into both eyes of each rabbit and the eyes were rinsed with physiological saline and then evaluated for corneal opacity with an UV-light.
All animals appeared healthy and active during the study. One hour after Mediator SNP instillation, corneal opacity was noted in 2 out of 3 rabbits and iritis and conjunctivitis were recorded in all three animals. The overall incidence and severity of irritation decreased gradually with time and no ocular irritation was noted at the 72-hour scoring period. The maximum mean score of Mediator SNP was 17.0 out of a possible 110. Using the Kay and Calandra scheme for classifying eye irritants, Mediator SNP is classified as “mildly irritating” to the eyes.
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