Registration Dossier
Registration Dossier
Diss Factsheets
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EC number: 627-083-1 | CAS number: 244235-47-0
- 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:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Version / remarks:
- adopted: 24th April 2002
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 1-(2-Hydroxy-5-nonyl(branched)-phenyl)ethanone oxime
- EC Number:
- 627-083-1
- Cas Number:
- 244235-47-0
- IUPAC Name:
- 1-(2-Hydroxy-5-nonyl(branched)-phenyl)ethanone oxime
- Details on test material:
- - Name of test material (as cited in study report): C-SAT090071
- Physical state: liquid
- Analytical purity: ca. 83 % with 8-10 % impurities (nonylphenol)
- Lot/batch No.: 5138
- Expiration date of the lot/batch: 30-4-2013
- Stability under test conditions: stable
- Storage condition of test material: room temperature
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- other: Crl:CHBB (HM) Russian rabbit
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland GmbH
- Age at study initiation: 9-12 months
- Weight at study initiation: 2.3-3.3 kg
- Housing: individually
- Diet: ad libitum
- Water: ad libitum
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 +- 3
- Humidity (%): 30-70
- Air changes (per hr): 10
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animals
- Amount / concentration applied:
- 0.1 ml
- Duration of treatment / exposure:
- single application
- Observation period (in vivo):
- 21 days
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): no
SCORING SYSTEM: according to OECD 405 guideline
TOOL USED TO ASSESS SCORE: light and fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: mean (24/48/72 hours)
- Score:
- 1.33
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: mean (24/48/72 hours)
- Score:
- 1
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: mean (24/48/72 hours)
- Score:
- 0.67
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: mean (24/48/72 hours)
- Score:
- 0.67
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: mean (24/48/72 hours)
- Score:
- 0.67
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: mean (24/48/72 hours)
- Score:
- 0.33
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: mean (24/48/72 hours)
- Score:
- 2.33
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: mean (24/48/72 hours)
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: mean (24/48/72 hours)
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: mean (24/48/72 hours)
- Score:
- 2
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: mean (24/48/72 hours)
- Score:
- 1.33
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: mean (24/48/72 hours)
- Score:
- 1.67
- Reversibility:
- fully reversible within: 7d
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: reading after installation of Fluorescein
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: reading after installation of Fluorescein
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: reading after installation of Fluorescein
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reading after installation of Fluorescein
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #1
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 3
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: moderate flow of tears
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: tight scab on the upper eyelid
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: without scab, but with a hairless fringe of the eyelid
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: reading after installation of Fluorescein
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: reading after installation of Fluorescein
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: reading after installation of Fluorescein
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #2
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: mild flow of tears
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: moderate flow of tears
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: mild flow of tears
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: moderate scab on the upper eyelid and moderate loss of hair around the eye
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: without scab, but with a moderate loss of hair on the upper eyelid
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: reading after installation of Fluorescein
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 1
- Max. score:
- 4
- Remarks on result:
- other: reading after installation of Fluorescein
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 1
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- iris score
- Basis:
- animal #3
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 1
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 3
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 1 h
- Score:
- 2
- Max. score:
- 4
- Remarks on result:
- other: moderate flow of tears
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 24 h
- Score:
- 3
- Max. score:
- 4
- Remarks on result:
- other: moderate flow of tears
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 48 h
- Score:
- 2
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 7 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: mild scab on the upper eyelid and moderate loss of hair around the eye
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 14 d
- Score:
- 0
- Max. score:
- 4
- Remarks on result:
- other: without scab, but with mild loss of hair on the upper eyelid
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- 21 d
- Score:
- 0
- Max. score:
- 4
Any other information on results incl. tables
One hour after the application of the test item, animal No. 4409 showed scattered or diffuse areas of opacity with details of iris clearly visible on about one quarter of the cornea area, some hyperaemic conjunctival blood vessels, a swelling above normal and a moderate flow of tears. Some hyperaemic conjunctival blood vessels, as welling above normal and a mild flow of tears were observed in animal No. 4410.
Animal No. 4414 showed an iris with markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia and an existing reaction to light, a conjunctiva with diffuse crimson colour and individual vessels not easily discernible, an obvious swelling with partial eversion of Iids as weil as a moderate flow of tears. 24 hours after the application of the test item, scattered or diffuse areas of opacity
with details of iris clearly visible on more than three quarters of the cornea area, an iris with markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia and an existing reaction to light, a conjunctiva with diffuse crimson colour and individual vessels not easily discernible, a swelling with Iids about half closed and a moderate flow of tears were observed in animal No. 4409. Animal No. 441 0 showed scattered or diffuse areas of opacity with details of iris clearly visible on about one quarter of the cornea area, an iris with markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia and an existing reaction to light, a conjunctiva with diffuse crimson colour and individual vessels not easily discernible, an obvious swelling with partial eversion of Iids and a moderate flow of tears. Scattered or diffuse areas of opacity with details of iris clearly visible on about one quarter of the cornea area, an iris with markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia and an existing reaction to light, a conjunctiva with diffuse crimson colour and individual vessels not easily discernible, a swelling with Iids about half closed and a moderate flow of tears were observed in animal No. 4414.
After the instillation of Fluorescein, animal No. 4409 showed an easily discernible translucent area with details of the iris slightly obscured on more than half, but less than three quarters of the cornea area. An easily discernible translucent area with details of the iris slightly obscured was observed on more than one quarter, but less than half of the cornea area of animal No. 4410, whereas animal No. 4414 showed
scattered or diffuse areas of opacity with details of iris clearly visible on more than one quarter, but less than half of the cornea area. 48 hours after the application of the test item, scattered or diffuse areas of opacity with details of iris clearly visible on more than three quarters of the cornea area, an iris with markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia and an existing reaction to light, a conjunctiva with diffuse beefy red colour and an obvious swelling with partial eversion of Iids were observed in animal No. 4409. Anima I No. 4410 showed scattered or diffuse areas of opacity with details of iris clearly visible on about one quarter of the cornea area, an iris with markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia and an existing reaction to light, a conjunctiva with diffuse crimson colour and individual vessels not easily discernible, an obvious swelling with partial eversion of Iids and a mild flow of tears. A conjunctiva with diffuse crimson colour and individual vessels not easily discernible as weil as an obvious swelling with partial eversion of Iids were observed in animal No. 4414.
After the instillation of Fluorescein, animal No. 4409 showed scattered or diffuse areas of opacity with details of iris clearly visible on more than one quarter, but less than half of the cornea area. Scattered or diffuse areas of opacity with details of iris clearly visible were observed on about one quarter of the cornea area of animal No. 4410 and No. 4414.
72 hrs after the application of the test item, animal No. 4409 showed scattered or diffuse areas of opacity with details of iris clearly visible on more than one quarter, but less than half of the cornea area, a conjunctiva with diffuse crimson colour and individual vessels not easily discernible as weil as a swelling above normal. Some hyperaemic conjunctival blood vessels were observed in animal No. 4410 and
No. 4414.
After the instillation of Fluorescein, animal No. 4409 showed scattered or diffuse areas of opacity with details of iris clearly visible on about one quarter of the cornea area.
Seven days after the application of the test item, no ocular reactions were observed in the eye of animal No. 4409, but tight scab was revealed on the upper eyelid.
Anima I No. 4410 showed moderate formation of scab on the upper eyelid and loss of hair around the eye. Mild formation o scab and loss of hair around the eye was observed in animal No. 4414.
Fourteen days after the application of the test item, animal No. 4409 still showed a hairless fringe of the eye but scab not any longer. The upper eyelid of animal No. 4410 was very hairless but free of scab. The loss of hair on the upper eyelid of animal No. 4414 was mild and scab was not present any longer. Twenty-one days after the application of the test item, animal No. 4409, No. 4410
and No. 4414 was free of signs of irritation. The hair was grown again in the adjacency of the eye.
Applicant's summary and conclusion
- Interpretation of results:
- Category 2 (irritating to eyes) based on GHS criteria
- Conclusions:
- The test substance is classified as irritating to eyes according to category 2 of the regulation (EC) No 1272/2008 (2008)7, because of the data concerning the opacity of the cornea obtained after the use of fluorescein.
- Executive summary:
The local effect of Ethanone, 1-(2-hydroxy-5-nonylphenyl)-, oxime, branched was investigated according to the method recommended in the OECD Guideline 405 (2002) and the council regulation (EC) No 440/2008 part B.5. (2008).
During an initial test, an amount of 0.1 ml of the undiluted test item was applied in one eye of a female albino rabbit. The eye was examined and the changes were graded according to a numerical scale after 1 hr, 24 hrs, 48 hrs and 72 hrs as well as on day 7,14 and 21. Well defined changes were observed in the treated eye. Since the animal used during the initial test did not show corneal defects on day 7, two more female albino rabbits were treated with 0.1 ml of the undiluted test item each. Likewise ocular defects were graded after 1 hr, 24 hrs, 48 hrs and 72 hrs as well as on day 7, 14 and 21. The two test animals showed also well defined changes concerning eyes. All observed effects were fully reversible within 7 days.
Based on the results of the study described in this report Ethanone, 1-(2-hydroxy-5-nonylphenyl)-, oxime, branched
• shall not be classified as irritating to eyes according to annex VI of the directive 67/548/EEC (2009)3 as well as the directive 2006/12 11EC (2006, 2007)4.S.
• shall be classified as irritating to eyes according to category 2B of the GHS (2007)6, because of the data concerning the opacity of the cornea obtained after the use of Fluorescein.
• shall be classified as irritating to eyes according to category 2 of the regulation (EC) No 1272/2008 (2008)7, because of the data concerning the opacity of the cornea obtained after the use of Fluorescein.
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