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EC number: 815-596-5 | CAS number: 1613307-27-9
- 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:
- 9th September 2013 - 12th November 2013
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 013
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- ethyl 2-(3-chloro-5-cyanophenoxy)acetate
- EC Number:
- 815-596-5
- Cas Number:
- 1613307-27-9
- Molecular formula:
- C11H11CINO3
- IUPAC Name:
- ethyl 2-(3-chloro-5-cyanophenoxy)acetate
- Test material form:
- solid
1
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- Bovine corneas were mounted in special holders and exposed to the test articles.
Bovine eyes were obtained from Spear Products and transported to MB Research in
Hank's Balanced Salt Solution (HBSS) in a refrigerated container. The eyes were examined within one hour after receipt. Any eye with a cornea exhibiting evidence of vascularization, pigmentation, opacity or scratches was discarded. Corneas from eyes that were free of defects were dissected from the surrounding tissues. A 2-3 mm rim of sclera was left attached to each cornea. The corneas were then placed in a container of fresh HBSS.
Test system
- Vehicle:
- other: Minimum Essential Media (MEM)
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 ml of a 20% suspension of L-005183690-000F003.
2 g of test article were brought to a total volume of 10 ml with MEM and mixed prior to dosing (Off-white particles suspended in clear liquid). - Duration of treatment / exposure:
- Five corneas were incubated in a horizontal position at 32°C for approximately 4 hours. Two corneas were incubated in the control at 32ºC.
- Observation period (in vivo):
- N/A
- Duration of post- treatment incubation (in vitro):
- The holders and corneas were then placed in the 32°C incubator for four hours in a horizontal position to insure contact of the test article with the corneas.
- Number of animals or in vitro replicates:
- Five corneas for the test article and two corneas for the control.
- Details on study design:
- Preparation of Corneas:
The eyes were examined within one hour after receipt. Any eye with a cornea exhibiting evidence of vascularization, pigmentation, opacity or scratches was discarded. Corneas from eyes that were free of defects were dissected from the surrounding tissues. A 2-3 mm rim of sclera was left attached to each cornea. The corneas were then placed in a container of fresh HBSS. The dissected corneas were mounted in specially designed holders that were separated into anterior and posterior chambers and filled separately. Each cornea was mounted allowing the epithelium of the cornea to project into the anterior chamber. The posterior chamber was filled with (MEM) solution ensuring contact with the endothelium. The anterior chamber was filled with MEM solution, ensuring contact with the epithelium. Each cornea was visually inspected again to insure there were no defects. The entire holder with the cornea was then placed in a 32°C incubator and allowed to equilibrate for at least one hour, but not longer than two hours. Following the equilibration, the holders containing the corneas were removed from the incubator. The MEM solution was removed from both chambers and the chambers refilled with fresh MEM solution. A pre-exposure determination of opacity was made for each control by measuring each against the blanks supplied by the opacitometer. A pre-exposure determination of opacity was made for each test cornea by measuring against each control cornea (a total of 10 determinations).
Test Item Preparation:
2 g of test article were brought to a total volume of 10 ml with MEM and mixed prior to dosing (Off-white particles suspended in clear liquid).
Treatment of Corneas and Opacity Measurements:
Following the pretest observations, the MEM solution was removed from the anterior chamber and 0.75 ml of the test article mixture was applied to the epithelium of each of the five treated corneas. The holders and corneas were then placed in the 32°C incubator in a horizontal position to insure contact of the test article with the corneas. After four hours, the test article (or MEM solution in the controls) was removed from the epithelium of the cornea and anterior chamber of the holder by washing with MEM solution. The anterior and posterior chambers of the holders were then refilled with fresh MEM solution and opacity measurements were made taken with each treated cornea compared to each of the two control corneas.
Opacity Measurement:
After 90 minutes, the fluid from the posterior chamber was removed and the amount of dye that passed through the cornea was measured as the optical density at 490 nm by spectrophotometric analysis.
Permeability Determinations and application of sodium fluorescein:
Immediately following the four hour opacity measurement, the MEM solution was removed from the anterior chamber and replaced with 1.0 ml of 0.5% sodium fluorescein solution in Dulbecco's Phosphate Buffered Saline (DPBS). Each holder was then returned to the 32°C incubator in a horizontal position insuring contact of the fluorescein with the cornea. After 90 minutes, the fluid from the posterior chamber was removed and the amount of dye that passed through the cornea was measured as the optical density at 490 nm by spectrophotometric analysis.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Value:
- -1.6
- Irritation parameter:
- in vitro irritation score
- Value:
- -0.9
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The in vitro score was calculated as -0.90 and is classified as a non-irritant (Southee. 1998).
- Executive summary:
Objective: To determine the potential for ocular irritation using an alternative to the Draize methodology. This protocol is based on the methodology described in "Bovine Corneal Opacity and Permeability Test: An In Vitro Assay of Ocular Irritancy, (1992)"; Gautheron, Pierre; Dukic, Martine; Alix, Danielle and Sina, Joseph F.; Fundamental and Applied Toxicology 18, 442-449. In Vitro classification based on Southee JA, 1998. Evaluation of the Prevalidation Process, Part 2, final report, Volume 2, The Bovine Corneal Opacity and Permeability (BCOP) Assay. European Community Contract No. 11279-95-10F lED ISP GB and included an analysis based on OECD Guideline for the Testing of Chemicals #437, adopted September 7,2009.
Method Synopsis: Five corneas were dosed with 0.75 ml of a 20% suspension of L-005183690-000F003. Opacity measurements and sodium fluorescein permeability were determined.
Summary: The corrected mean opacity score was -1.6. The corrected mean optical density (permeability) score was 0.047.
Conclusion: The in vitro score was calculated as -0.90 and is classifled as a non-irritant (Southee, 1998).
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