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EC number: 205-153-9 | CAS number: 134-71-4
- 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: Non-GLP guideline study, available as unpublished report, minor restrictions in design and/or reporting but otherwise adequate for assessment
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 986
- Report date:
- 1986
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 405 (Acute Eye Irritation / Corrosion)
- GLP compliance:
- no
Test material
- Reference substance name:
- (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride
- EC Number:
- 205-153-9
- EC Name:
- (R*,S*)-(±)-α-[1-(methylamino)ethyl]benzyl alcohol hydrochloride
- Cas Number:
- 134-71-4
- Molecular formula:
- C10 H15 N O .Cl H
- IUPAC Name:
- (1-hydroxy-1-phenylpropan-2-yl)(methyl)azanium chloride
- Details on test material:
- - Name of the test substance used in the study report: DL-Ephedrin-HCl
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- Vienna White
- Details on test animals or tissues and environmental conditions:
- TEST ANIMALS
- Source: Gaukler, D-6050 Offenbach/Main, FRG
- Weight at study initiation: males 2.81 kg and females 3.06 kg
- Housing: 1 animal per stainless steel cage with wire mesh walk floors, floor area: 40 cm x 51 cm, no bedding in cages, sawdust in the waste trays.
- Diet: 130 g per animal per day, Kliba 341, 4 MM; Firma Klingentalmuehle AG , CH-4303 Kaiseraugst, Switzerland
- Water: 250 mL per day, tap water
- Acclimation period: at least 8 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 - 24
- Humidity (%): 30 - 70
- Air: fully air-conditioned rooms
- Photoperiod (hrs dark / hrs light): 12/12
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: untreated eye of the same animal
- Amount / concentration applied:
- 0.1 mL bulk volume (about 44 mg of the comminuted test substance) applied to the conjunctival sac of the right eyelid
- Duration of treatment / exposure:
- Single application
- Observation period (in vivo):
- 72 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- The test substance was not removed / washed out.
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- cornea opacity score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 2
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 1
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- conjunctivae score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 1.3
- Max. score:
- 3
- Reversibility:
- fully reversible within: 72 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #1
- Time point:
- other: 24 - 72 h
- Score:
- 0
- Max. score:
- 4
- Irritation parameter:
- chemosis score
- Basis:
- animal #2
- Time point:
- other: 24 - 72 h
- Score:
- 0.3
- Max. score:
- 4
- Reversibility:
- fully reversible within: 48 hours
- Irritation parameter:
- chemosis score
- Basis:
- animal #3
- Time point:
- other: 24 - 72 h
- Score:
- 0.7
- Max. score:
- 4
- Reversibility:
- fully reversible within: 72 hours
- Irritant / corrosive response data:
- Suppuration was also observed in animal #2, at the 24 hour timepoint.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information
- Conclusions:
- Under the conditions of the test, the substance is considered to be not irritating or corrosive to the eye.
- Executive summary:
The potential to cause damage to the conjunctiva, iris and cornea was assessed in an OECD 405 guideline study in 3 white Vienna rabbits subjected to a single ocular application of 0.1 mL (approx. 44 mg) of the test substance on day 0. The mean score (24 to 72 hours) for irritation was calculated to be 0.3, 0, and 0 for corneal opacity, 0, 0, and 0 for iritis, 1, 1, and 1.3 for chemosis, and 0, 0.3, and 0.7 for conjunctivae redness, for animal 1, 2, and 3 respectively. Findings were reversible within 72 hours after application. It was concluded that the test substance was not irritating to the eye.
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