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EC number: 615-206-1 | CAS number: 709031-45-8
- 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
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Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September to December 2002
- Reliability:
- 1 (reliable without restriction)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- GLP compliance:
- yes
Test material
- Reference substance name:
- (1S,3S,5S)-2-azabicyclo[3.1.0]hexane-3-carboxamide
- EC Number:
- 615-206-1
- Cas Number:
- 709031-45-8
- Molecular formula:
- C6H10N2O.CH4O3S
- IUPAC Name:
- (1S,3S,5S)-2-azabicyclo[3.1.0]hexane-3-carboxamide
- Test material form:
- solid
- Details on test material:
- Appearance: light tan solid
Storage conditions: at room temp, protected by light
Constituent 1
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Bovine eyes, excised by an abattoir employee, were collected as soon after slaughter as possible ( excised at -10:35 hours on 11 September 2002). Instructions were given to avoid damaging the corneas during excision. Excised eyes were maintained and transported to the laboratory, at ambient temperature, in sufficient HBSS, containing I% (v/v) Penicillin/Streptomycin solution, to cover all the eyes in the receptacle. The eyes were used within 4 hours of slaughter (incubation of mounted corneas commenced at 13:43 hours on 11 September 2002).
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 20% (w/w) solution or suspension in 0.9% sodium chloride solution
- Duration of treatment / exposure:
- Corneas were incubated in a horizontal position for 4 hours at 32C
- Duration of post- treatment incubation (in vitro):
- Following incubation, the test substance was removed and the epithelial surface of the cornea washed, at least 3 times or until the wash medium was clear, with cMEM added via the holes on the top of the holder. After each wash, the wash medium was removed using a pipette tip attached to a vacuum pump. Following completion of the wash step, the medium was removed from both compartments which were re-filled with fresh cMEM. The posterior compartment was re-plugged and the opacity of each cornea measured and recorded. The opacity values obtained at this stage were used in calculating the final inVitro Score.
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- All eyes were carefully examined, macroscopically, for defects (opacity, scratches, pigmentation, cuts, etc.) and those exhibiting defects were discarded. The tissue surrounding the eyeball was carefully pulled away and the cornea dissected leaving approximately 2 to 3 mm of sclera present around the cornea. The isolated corneas were stored in a petri dish containing HBSS plus 1 % Penicillin/Streptomycin solution until all the corneas had been dissected. Once all the corneas had been dissected, they were rinsed in fresh HBSS plus 1% Penicillin/Streptomycin solution prior to mounting.
The corneas were mounted in the cornea holders with the endothelial side against the 0-ring of the posterior half of the holder. Each cornea was gently flattened over the 0-ring and holder surface with a wetted, gloved finger to expel any air. The anterior half of the holder was then positioned on top of the cornea and secured with screws. Both compartments of the holder were filled with cMEM, using a syringe. The posterior compartment was always filled first to return the cornea to its natural shape. Care was taken to ensure no air bubbles were present within the holders. The holders were then plugged and incubated, in an upright position, for 60 minutes ± 5 minutes at 32°C ± 2°C in a waterbath. The
waterbath temperature remained within the limits of 32°C ± 2°C throughout the experiment.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Value:
- 31.7
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- other: Permeability
- Value:
- 0.082
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Value:
- 32.9
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Interpretation of results:
- Category 2A (irritating to eyes) based on GHS criteria
- Conclusions:
- The Bovine Corneal Opacity and Permeability Assay (BCOP) was performed to assess the ocular initancy potential in vitro of test substance BMS 482204-03 (MSA Salt). Imidazole was tested in parallel as a positive control.
Two endpoints, corneal opacity and permeability, were measured in the assay. These measurements were combined to give an In Vitro Score which was used to determine the potential eye irritancy of the test substance according to the Prediction Model developed by Curren el al (1996). In Vitro Scores up to 25 are classified as negative and scores greater than 25 are classified as positive potential eye irritants.
The test sample, BMS 482204-03 (MSA Salt), elicited an In Vitro Score of 32.9 ± 7.1 and was classified as a positive potential eye irritant.
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