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EC number: 482-140-6 | CAS number: 13641-96-8
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 24 April 2007
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Comparable to guideline study, performed under GLP conditions. Study was performed before actual guideline was accepted.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD 437 (BCOP test for corrosivity/severe irritation)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- MHRA, UK GLP Monitoring Authority
Test material
- Reference substance name:
- -
- EC Number:
- 482-140-6
- EC Name:
- -
- Cas Number:
- 13641-96-8
- Molecular formula:
- Hill formula: C6 H7 N O3 CAS formula: C6 H7 N O3
- IUPAC Name:
- 2-isocyanatoethyl prop-2-enoate
Constituent 1
Test animals / tissue source
- Species:
- other: bos
- Strain:
- other: not applicable, in vitro test
- Details on test animals or tissues and environmental conditions:
- In vitro test system, isolated corneas from the eyes of freshly slaughtered cattle were used.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- other: Negative control sodium chloride
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 µL
- Concentration (if solution): undiluted - Duration of treatment / exposure:
- 10 min
- Observation period (in vivo):
- Not applicable, in vitro test system. Additional 2 hours incubation time after rinsing.
- Number of animals or in vitro replicates:
- Not applicable, in vitro test system. Corneas used in triplicate
- Details on study design:
- REMOVAL OF TEST SUBSTANCE
- Washing (if done): yes, 5 washes until wash medium was clear
- Time after start of exposure: 10 min
SCORING SYSTEM:
OPACITY MEASUREMENT:
The opacitometer measured the light transmission through the centre of each mounted cornea, displaying a numerical opacity value (arbitrary unit). The opacity of each cornea was measured by reading each holder in the right-hand chamber of the calibrated opacitometer. Once the basal opacity of all the corneas had been measured, the mean basal opacity value was calculated. Any corneas deviating from the mean by more than 3 units were discarded.
After washing and the 2 hour incubation period the opacities of the corneas were determined again. The opacity values obtained at this stage were used in calculating the final In Vitro Score. Throughout the assay the corneas were examined for opaque spots or other irregularities; any atypical characteristics were recorded.
The change in the opacity of each cornea was calculated by subtracting the initial basal opacity from the post-treatment opacity measurement. The mean change in opacity for the negative control corneas was calculated and was subtracted from the change in opacity of each treated cornea to obtain the corrected opacity value. The mean corrected opacity change value of each treatment group (of 3 corneas) was calculated from the individual corrected opacity values of the treated corneas.
PERMEABILITY DETERMINATION:
Following the final opacity measurement, the medium was removed from the anterior compartment of the holder. One mL (1mL) of sodium fluorescein solution was added to the anterior compartment. Following addition of the sodium fluorescein solution to the anterior side of the holder, the compartment was plugged and the corneas incubated in a horizontal position at 32°C ± 2°C for 90 ± 5 minutes in a waterbath.
Following incubation, the medium in the posterior compartment was mixed by drawing approximately 2.5 ml gently up and down a 5 ml syringe, with a needle attached, three times. An aliquot of the mixed medium from the posterior compartment was removed and transferred to a 1 cm path length cuvette. A spectrophotometer was adjusted to read at 490nm (OD490) and a sample of cMEM read (OD =0.066). The spectrophotometer was blanked using this solution prior to reading the permeability samples. Any solution giving an OD490 value above 1.8 was diluted 1 in 5 with cMEM.
The corrected permeability value (OD490) of each treated cornea was calculated by subtracting the mean negative control cornea value from the permeability value of each cornea. The mean corrected permeability value of each treatment group was calculated from the individual corrected permeability values of the treated corneas.
IN VITRO SCORE CALCULATION:
The In Vitro Score was calculated using the following formula:
In Vitro Score = Corrected Opacity Value + (15 x Corrected OD490 Value)
The In Vitro Score was calculated for each individual treatment and positive control cornea. The mean In Vitro Score value for each treatment group was calculated from the In Vitro Scores of each individual cornea in the treatment group.
PREDICTION MODEL:
The test substance was classified as a negative irritant if the In Vitro Score was 0-25 and as a positive irritant if the Score was >25 according to the thresholds developed by Curren et al (1996).
TOOL USED TO ASSESS SCORE: opacitometer, spectrophotometer
Results and discussion
In vitro
Results
- Irritation parameter:
- other: In Vitro Score
- Value:
- 23.4
- Remarks on result:
- other: Basis: mean. Time point: 10 min. Reversibility: other: not applicable, in vitro test system. Remarks: Negative (non-irritating)
- Other effects / acceptance of results:
- When the Threshold Prediction Model (Curren et al.) is applied, the test substance AOI, with an In Vitro Score of 23.4 ± 3.5, is classified as a negative potential eye irritant.
Applicant's summary and conclusion
- Interpretation of results:
- other: not irritating
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