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EC number: 700-527-2 | CAS number: 1271488-66-4
- 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 vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2 November 2010 - 9 December 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed in accordance an OECD guideline by a GLP accredited laboratory. A protocol for the test substance has been developed.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
- Report date:
- 2010
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OECD 437
- Deviations:
- no
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: OTWG, ICCVAM and NICEATM, Background Review Document: current status of in vitro test methods for identifying ocular corrosives and severe irritants: BCOP test method, March 2006
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: In vitro Techniques in Toxicology Database (NINVITTOX) protocol 124, Bovine Opacity and Permability Assay-SOP of Microbiological Associates Ltd 1999.
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- other: Gautheron P. et al., Bovine corneal opacity and permeability test: An in vitro assay of ocular irritancy, Fundam. Appl. Toxicol. 18:442-449, 1992
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- methyl trans-3-oxo-2-pentylcyclopentanecarboxylate
- EC Number:
- 700-527-2
- Cas Number:
- 1271488-66-4
- Molecular formula:
- C12H20O3
- IUPAC Name:
- methyl trans-3-oxo-2-pentylcyclopentanecarboxylate
Constituent 1
Test animals / tissue source
- Details on test animals or tissues and environmental conditions:
- Bovine eyes from young cattle (Vitelco, 's-Hertogenbosch, NL) obtained byexcission and used as soon as possible after slaughter. Eyes were collected and transported in physiological saline.
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- 750 µl of the test substance or control was put onto the epithelium of the cornea. Holders were slightly rotated with the cornea maintained in horizontal position.
- Duration of treatment / exposure:
- The incubation period was 10±1 min at 32±1°C.
- Number of animals or in vitro replicates:
- 9 eyes
- Details on study design:
- Randomly selected corneas were selected and their opacities measured. If the opacity was >3, the cornea was not used for the test. Corneas were mounted in a MC2 (Clermont, France) corneal holder. The compartments of the corneal holder were filled with cMEM. The corneas were incubated for the minimum of 1 hour at 32+/-1oC. 0.750 ml of the control or test substance was put onto the epithelium of the cornea. After 10 minutes, the cornea was washed with MEM with phenol red (to assess pH effects) and cMEM containing phenol red to evaluate possible pH effects. The anterior and posterior compartments of the cornea holder was filled with fresh cMEM and the corneas were incubated for 120+/-10 minutes at 32+/-1oC. After incubation, the opacity was determined and each cornea was inspected visually for dissimilar opacity patterns.
Opacity measurements were based on light transmission across the cornea. The change in opacity is the difference in transmission between pre and post treatment reading. The corrected opacity is calculated by subtracting the average change in opacity of the negative control corneas from the change in opacity of the cornea treated with test material, positive control or solvent control. The mean opacity value is the average of the corrected opacity values of the with test material treated corneas.
In the permeability test, the anterior compartment of the cornea holder was filled with 1 ml of 4 mg sodium-fluorescein/ml cMEM solution and the posterior with cMEM only. Corneas were incubated for a period of 90+/-5 minutes at 32+/-1oC. The optical density (OD) of the medium in the posterior compartment was measured in triplicate using a microplate reader (Multiskan spectrum, Thermo labsystems) at a wavelength of 490 nm.
The irritation potential was assessed on the individual mean opacity and mean permeability values. An in vitro irritancy score was based on the mean opacity and mean permeability values according to the following equation:
In vitro irritancy score (IVIS) = mean opacity value + (15 x mean OD490 value)
An IVIS > 55.1 means that the test substance should be regarded as a corrosive or severe irritant.
The study is acceptable if IVIS is less than two standard deviations from the historical mean and if the opacity and permeability values of the negative control is less than the upper limit of the historical range (acceptability criteria).
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- other: Opacity
- Basis:
- mean
- Time point:
- other: 2h.
- Score:
- 0
- Irritation parameter:
- other: Permeability
- Basis:
- mean
- Time point:
- other: 1.5h.
- Score:
- 3.54
- Irritation parameter:
- overall irritation score
- Remarks:
- In vitro irritancy score (IVIS)
- Basis:
- mean
- Score:
- 0
- Remarks on result:
- other: If IVIS >= 55.1, then test substance is classified as corrosive or severe irritant.
- Irritant / corrosive response data:
- TABLE I presents the individual opacity scores, in which the mean responses of the negative control is in compliance with the acceptability criteria. The individual permeability scores uncorrected and corrected for the negative control can be found in TABLE II and III. The mean final negative control is within the historical control range. TABLE IV shows the in vitro irritancy scores (IVIS) that takes both the opacity and permeability scores into account. The positive control benzalkonium chloride solution had a mean in vitro irritancy score within the historical range.
Any other information on results incl. tables
TABLE I Individual opacity scores
Eye | Opacity before treatment | Opacity after treatment | Final Opacity1 | Negative control corrected final opacity | Mean |
negative control | |||||
1 | 0 | 0 | 0 | 0 | |
2 | 0 | 0 | 0 | 0 | 0 |
3 | 0 | 0 | 0 | 0 | |
positive control | |||||
1 | 0 | 81 | 81 | 81 | |
2 | 0 | 76 | 76 | 76 | 80 |
3 | 0 | 83 | 83 | 83 | |
Test substance | |||||
1 | 0 | 0 | 0 | 0 | |
2 | 0 | 0 | 0 | 0 | 0 |
3 | 1 | 0 | -1 | -1 | |
1Final opacity = opacity after treatment - opacity before treatment |
TABLE II Individual permaebility scores (uncorrected)
Eye | Dilution factor | OD490 1 |
OD490 2 |
OD490 3 |
Average OD | Final OD |
negative control | ||||||
1 | 1 | 0.011 | 0.010 | 0.013 | 0.011 | |
2 | 1 | 0.009 | 0.012 | 0.006 | 0.009 | |
3 | 1 | 0.011 | 0.006 | 0.005 | 0.007 | |
positive control | ||||||
1 | 6 | 0.653 | 0.639 | 0.631 | 0.641 | 3.846 |
2 | 6 | 0.523 | 0.530 | 0.517 | 0.523 | 3.138 |
3 | 6 | 0.640 | 0.632 | 0.626 | 0.633 | 3.798 |
Test substance | ||||||
1 | 1 | 0.010 | 0.005 | 0.005 | 0.007 | 0.007 |
2 | 1 | 0.014 | 0.010 | 0.007 | 0.010 | 0.010 |
3 | 1 | 0.009 | 0.007 | 0.007 | 0.008 | 0.008 |
1Final OD = OD x dilution factor | ||||||
Mean final negative control is 0.009 |
TABLE III Individual permaebility scores (corrected for the mean final negative control)
Eye | Dilution factor | OD490 1 |
OD490 2 |
OD490 3 |
Average OD | Final OD1 |
negative control | ||||||
1 | 1 | 0.002 | 0.001 | 0.004 | 0.002 | |
2 | 1 | 0.000 | 0.003 | -0.003 | 0.000 | |
3 | 1 | 0.002 | -0.003 | -0.004 | -0.002 | |
positive control | ||||||
1 | 6 | 0.644 | 0.630 | 0.622 | 0.632 | 3.792 |
2 | 6 | 0.514 | 0.521 | 0.508 | 0.514 | 3.084 |
3 | 6 | 0.631 | 0.623 | 0.617 | 0.624 | 3.744 |
Test substance | ||||||
1 | 1 | 0.001 | -0.004 | -0.004 | -0.002 | -0.002 |
2 | 1 | 0.005 | 0.001 | -0.002 | 0.001 | 0.001 |
3 | 1 | 0.000 | -0.002 | -0.002 | -0.001 | -0.001 |
1Final OD = OD x dilution factor | ||||||
Mean final negative control is 0.009 |
TABLE IV In vitro irritancy score (IVIS)
Eye | Negative control corrected final opacity | Negative control corrected final OD490 | IVIS |
negative control | |||
1 | 0 | 0.002 | 0.0 |
2 | 0 | 0.000 | 0.0 |
3 | 0 | -0.002 | 0.0 |
mean | 0 | 0.000 | 0.0 |
positive control | |||
1 | 81 | 3.792 | 137.9 |
2 | 76 | 3.084 | 122.3 |
3 | 80 | 3.744 | 139.2 |
mean | 80 | 3.540 | 133 |
Test substance | |||
1 | 0 | -0.002 | 0.0 |
2 | 0 | 0.001 | 0.0 |
3 | -1 | -0.001 | 0.0 |
mean | 0 | -0.001 | 0 |
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: OECD GHS
- Conclusions:
- The test solution did not induce ocular irritation through both end-points. The mean in vitro irritancy score was 0 after 10 minutes of exposure.
- Executive summary:
Eye irritancy of the test substance was screened by the Bovine Corneal Opacity and Permability (BCOP) test. The study included a negative (physiological saline) and a positive control (10% (w/v) benzalkonium chloride in physiological saline). The test substance or controls were topically applied and exposure to the test substance was 10 minutes. The opacity was determined spectrophotometrically at 490nm. The test substance did not have any effect on the opacity. No pH effects were observed as seen by rinsing the eye with a solution containing phenol red. In the permeability test with sodium-fluorescein, no permeability was observed.
The in vitro irritancy score (IVIS) was based on both the opacity and permeability results. The IVIS was also 0 and hence the test substance does not induce ocular irritation and should not be regarded as severe irritant for or corrosive to the eye.
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