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EC number: 273-453-7 | CAS number: 68966-86-9
- 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:
- 2017
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 017
- Report date:
- 2017
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
- Version / remarks:
- July 2013
- Deviations:
- yes
- Remarks:
- The OECD guideline 437 recommends the use of EMEM which is in composition and osmolarity equivalent to the MEM, thus MEM can be used without restriction.
- Qualifier:
- according to guideline
- Guideline:
- other: Bovine Corneal Opacity and Permeability (BCOP) Assay, SOP of Microbiological Associates Ltd., UK, Procedure Details
- Version / remarks:
- April 1997
- Deviations:
- not specified
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- Methyl 4(or 1)-isopropyl-1(or 4)-methylbicyclo[2.2.2]oct-5-ene-2-carboxylate
- EC Number:
- 273-453-7
- EC Name:
- Methyl 4(or 1)-isopropyl-1(or 4)-methylbicyclo[2.2.2]oct-5-ene-2-carboxylate
- Cas Number:
- 68966-86-9
- Molecular formula:
- C14H22O2
- IUPAC Name:
- Methyl 4(or 1)-isopropyl-1(or 4)-methylbicyclo[2.2.2]oct-5-ene-2-carboxylate
Constituent 1
Test animals / tissue source
- Species:
- other: Bovine eyes
- Strain:
- other: Cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: AB Schlachthof GmbH Aschaffenburg
- Number of animals: Not reported
- Characteristics of donor animals (e.g. age, sex, weight): At least 9 month old donor cattle
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions):Isolated eyes were stored in HBSS containing 1% (v/v) Penicillin/Streptomycin (100 units/mL penicillin and 100 μg/mL streptomycin) in the cooled abattoir until transportation on the same morning to the laboratory.
- Time interval prior to initiating testing: The corneae were isolated on the same day as delivery
- indication of any existing defects or lesions in ocular tissue samples: All eyes were carefully examined macroscopically for defects with those presenting defects discarded.
- Indication of any antibiotics used: Eyes were stored in HBSS containing 1% (v/v) Penicillin/Streptomycin (100 units/mL penicillin and 100 μg/mL streptomycin)
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.75 mL
- Concentration (if solution): Neat test item
VEHICLE: not applicable - Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 2 hours
- Number of animals or in vitro replicates:
- 3
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS: All eyes were carefully examined macroscopically for defects with those presenting defects discarded. The cornea was carefully removed from the eye using scalpel and rounded scissors. A rim of about 2 mm of tissue was left for stability and handling of the isolated cornea. Each isolated cornea was mounted in a specially designed cornea holder according to the OECD 437 guideline 437. The endothelial side of the cornea was positioned against the sealing ring of the posterior part of the holder. The cornea was gently flattened over the O-ring but stretching was avoided. The anterior part of the holder was positioned on top of the cornea and fixed in place with screws. Both compartments of the holder were filled with incubation medium with the posterior compartment filled first to return the cornea to its natural convex position. Care was taken to assure no air bubbles were present within the compartments. For equilibration, the corneae in the holder were incubated in a vertical position for about one hour at 32 ± 1 °C in a water-bath.
QUALITY CHECK OF THE ISOLATED CORNEAS: At the end of the incubation period, the basal opacity was determined (t0). Cornea with a score of > 7 was discarded.
NUMBER OF REPLICATES: 3
NEGATIVE CONTROL USED: Saline (0.9% NaCl in deionised water, using ultrasonic technique)
POSITIVE CONTROL USED: 2-Ethoxyethanol (purity: 99%)
APPLICATION DOSE AND EXPOSURE TIME: 0.75 mL of neat test item
TREATMENT METHOD: [closed chamber / open chamber]
POST-INCUBATION PERIOD: No
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period:1
- POST-EXPOSURE INCUBATION:2 hours at 32 ± 1 ºC
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: Calibrated opacitometer
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of UV/VIS spectrophotometry(OD490)
- Others (e.g, pertinent visual observations, histopathology): None reported
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: According to guideline
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Cornea 1
- Value:
- 0.05
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Cornea 2
- Value:
- -0.22
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Cornea 3
- Value:
- 1.27
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- 0.37
- Vehicle controls validity:
- not applicable
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: None reported
DEMONSTRATION OF TECHNICAL PROFICIENCY: Validity criteria met
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
- Range of historical values if different from the ones specified in the test guideline: Not applicable
Any other information on results incl. tables
Results after 10 minute treatment time:
Test Group | Opacity value = Difference (t130 - t0) of Opacity | Permeability at 490 nm (OD490) | IVIS | Mean IVIS | Proposed in vitro Irritancy score | ||
Mean | Mean | ||||||
Negative control | 0 | 0.00 | 0.085 | 0.072 | 1.28 | 1.09 | Not categorised |
0 | 0.067 | 1.01 | |||||
0 | 0.065 | 0.98 | |||||
Positive control | 96.00* | 1.152* | 113.28 | 103.28 | Category 1 | ||
83.00* | 1.501* | 105.51 | |||||
77.00* | 0.938* | 91.07 | |||||
Test item | 0.00* | 0.004* | 0.05 | 0.37 | Not categorised | ||
0.00* | -0.014* | -0.22 | |||||
1.00* | 0.018* | 1.27 |
*corrected values
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Relative to the negative control, the test item did not cause an increase of the corneal opacity or permeability. The calculated mean in vitro irritancy score was 0.37.
According to OECD 437 (see table in chapter 3.8.3) the test item is not categorized (GHS). - Executive summary:
The test item was assessed for eye irritation in a Bovine Corneal Opacity and Permeability Assay (BCOP) conducted following OECD
437, and EU B.47 in undiluted form alongside a postive and negative control. The results of the test indicates that the test item does not possess an eye irritating potential according to the UN GHS regulations.
The study is a GLP compliant guideline experiment study available as an unpublished study report. The study has no restrictions and is fully adequate for assessment.
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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