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EC number: 402-030-3 | CAS number: 624-86-2
- 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: Comparable to guideline study with acceptable restrictions (no data on substance purity)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- Deviations:
- yes
- Remarks:
- (Additional 3 animals were included in the test panel. The eyes of these 3 animals were rinsed)
- GLP compliance:
- yes
Test material
- Reference substance name:
- O-ethylhydroxylamine
- EC Number:
- 402-030-3
- EC Name:
- O-ethylhydroxylamine
- Cas Number:
- 624-86-2
- Molecular formula:
- C2 H7 N O
- IUPAC Name:
- O-ethylhydroxylamine
- Details on test material:
- - CTL reference number: Y05460/002/001
- Name of test substance as cited in document: Substance H109360
- Identification of test sample as stated in report: 50% (w/v) aqueous solution (approx. 46.4% ethoxyamine and approx. 5% ethanol)
- Appearance: clear aqueous solution
- Lot #: EFI-100
- Analytical purity: not specified
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Mellor Rabbits, Chadderton Heights, Chadderton, Nr Oldham, Greater Manchester, UK .
- Age at study initiation: no data
- Weight at study initiation: 2669-3245g
- Housing: singly in satinised aluminium sheet cages
- Diet: Labsure CRB Rabbit Diet provided ad libitum
- Water: via an automatic system provided ad libitum
- Acclimation period: 6 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 16
- Humidity (%): 40-60
- Air changes (per hr): 20-30
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: right eye (untreated)
- Amount / concentration applied:
- - Amount applied: 0.1 ml
- Duration of treatment / exposure:
- Eyes were washed in 3/6 animals 30-36 seconds after instillation. The eyes of the remaining 3 animals were not washed
- Observation period (in vivo):
- approximately 1 hour, 1, 2, 3 and 4 days after instillation, day 6 after instillation (only 3 animals), day 7 (only 4 animals)
- Number of animals or in vitro replicates:
- 6
- Details on study design:
- The initial pain reaction of the first rabbit after treatment was moderate and the irritation was less than severe. The eyes of the remaining rabbits were
pretreated 3-4 minutes before instillation of the test sample with one drop of a local anaesthetic (OPHTHAINE, 0.5% proparacaine hydrochloride solution)
REMOVAL OF TEST SUBSTANCE
- Washing; yes, with 200-300 ml luke warm water for approx 2 min
- Time after start of exposure: 30-36 seconds
- Number of rabbits: 3
SCORING SYSTEM: Draize scale (Draize 1959)
TOOL USED TO ASSESS SCORE: fluorescein
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- ca. 0.77
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Individual means of Animal # 1 = 1; Animal # 2 = 0.66; Animal # 3 = 0.66
- Irritation parameter:
- iris score
- Basis:
- mean
- Remarks:
- 3 animals
- Time point:
- 24/48/72 h
- Score:
- 0.44
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Individual means of Animal # 1 = 0.33; Animal # 2 = 0.33; Animal # 3 = 0.66
- Irritation parameter:
- conjunctivae score
- Remarks:
- (washed eyes)
- Basis:
- mean
- Remarks:
- (of 3 animals)
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.33
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Individual means of Animal # 1 = 1; Animal # 2 = 1.67; Animal # 3 = 1.33
- Irritation parameter:
- chemosis score
- Remarks:
- (washed eyes)
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 1.1
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Individual means of Animal # 1 = 1.33; Animal # 2 = 1.0; Animal # 3 = 1.0
- Irritation parameter:
- cornea opacity score
- Remarks:
- (unwashed eyes)
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.66
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Individual means of Animal # 1 = 0.66; Animal # 2 = 0.33; Animal # 3 = 1.0
- Irritation parameter:
- iris score
- Remarks:
- (unwashed eyes)
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24, 48 and 72 h ours
- Score:
- 0.44
- Max. score:
- 2
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Individual means of Animal # 1 = 1; Animal # 2 = 0; Animal # 3 = 0.33
- Irritation parameter:
- conjunctivae score
- Remarks:
- (unwashed eyes)
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.89
- Max. score:
- 3
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Individual means of Animal # 1 = 1.0; Animal # 2 = 0.66; Animal # 3 = 1.0
- Irritation parameter:
- chemosis score
- Remarks:
- (unwashed eyes)
- Basis:
- mean
- Remarks:
- of 3 animals
- Time point:
- other: 24, 48 and 72 hours
- Score:
- 0.73
- Max. score:
- 4
- Reversibility:
- fully reversible within: 7 days
- Remarks on result:
- other: Individual means of Animal # 1 = 0.66; Animal # 2 = 1.0; Animal # 3 = 0.66
- Other effects:
- - Instillation of 0.1 ml of the test sample into the rabbit eye caused moderate initial pain in one rabbit. The eyes of the remaining five rabbits were pretreated with the local anaesthetic OPHTHAINE. One of these five rabbits had practically no initial pain, the remaining four showed no initial pain.
- Additional observations seen in all three animals whose eyes were washed included; epithelial erosion of the cornea, haemorrhagic nictitating membrane, haemorrhagic conjunctiva, convoluted eyelids, erythema of the upper and/or lower eyelid and Harderian discharge. All effects were reversible within 7 days.
Additional observations seen in animals whose eyes remained unwashed were convoluted eyelids (1/3 animals; reversible within 3 days), eye appeared cyanosed (2/3 animals; reversible within 7 days), erythema of the upper and/or lower eyelid (1/3 animals; not reversible within 6 days) and Harderian discharge (1/3 animals; reversible within 3 days)
Any other information on results incl. tables
.
Applicant's summary and conclusion
- Interpretation of results:
- irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the conditions of this study, the test substance (Substance H109360) is considered to be irritating to the eyes.
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