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EC number: 946-427-4 | CAS number: -
- 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
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- Endpoint summary
- Stability
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- 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
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- Endocrine disrupter testing in aquatic vertebrates – in vivo
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- Sediment toxicity
- Terrestrial toxicity
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- 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:
- 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
Materials and methods
Test guideline
- 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:
- 2017
- Deviations:
- no
- Remarks:
- No deviations occurred that impacted the results of the study.
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-[[1-(chloromethyl)-2-[[4-(oxiran-2-ylmethoxymethyl)cyclohexyl]methoxy]ethoxy]methyl]oxirane
- Molecular formula:
- C17H29ClO5
- IUPAC Name:
- 2-[[1-(chloromethyl)-2-[[4-(oxiran-2-ylmethoxymethyl)cyclohexyl]methoxy]ethoxy]methyl]oxirane
- Reference substance name:
- cis-1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane
- Cas Number:
- 1197197-64-0
- Molecular formula:
- C14H26O4
- IUPAC Name:
- cis-1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane
- Reference substance name:
- trans-1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane
- Cas Number:
- 158307-92-7
- Molecular formula:
- C14H26O4
- IUPAC Name:
- trans-1,4-bis[(2,3-epoxypropoxy)methyl]cyclohexane
- Reference substance name:
- [4-(oxiran-2-ylmethoxymethyl)cyclohexyl]methanol
- Molecular formula:
- C11H20O3
- IUPAC Name:
- [4-(oxiran-2-ylmethoxymethyl)cyclohexyl]methanol
- Reference substance name:
- [4-[[3-chloro-2-(oxiran-2-ylmethoxy)propoxy]methyl]cyclohexyl]methanol
- Molecular formula:
- C14H25ClO4
- IUPAC Name:
- [4-[[3-chloro-2-(oxiran-2-ylmethoxy)propoxy]methyl]cyclohexyl]methanol
- Reference substance name:
- 2-[[3-chloro-2-[[4-[[3-chloro-2-(oxiran-2-ylmethoxy)propoxy]methyl]cyclohexyl]methoxy]propoxy]methyl]oxirane
- Molecular formula:
- C20H34Cl2O6
- IUPAC Name:
- 2-[[3-chloro-2-[[4-[[3-chloro-2-(oxiran-2-ylmethoxy)propoxy]methyl]cyclohexyl]methoxy]propoxy]methyl]oxirane
Constituent 1
Constituent 2
Constituent 3
impurity 1
impurity 2
impurity 3
impurity 4
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: 3M Company
- Expiration date of the lot/batch: 26 May 2022
- Purity test date: 05 December, 2017
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Storage condition of test material: At room temperature
- Stability under test conditions: Stable
TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: None, test article was applied neat.
Test animals / tissue source
- Species:
- cattle
- Details on test animals or tissues and environmental conditions:
- SOURCE OF COLLECTED EYES
- Source: Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
- Number of animals: No data but at least 9 individual corneas were required.
- Characteristics of donor animals (e.g. age, sex, weight): No data.
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): Eyes were collected and transported in physiological saline in a suitable container under cooled conditions.
- Time interval prior to initiating testing: No data
- indication of any existing defects or lesions in ocular tissue samples: The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.
- Indication of any antibiotics used: No data.
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): 750 uL
VEHICLE: None - Duration of treatment / exposure:
- 10 minutes
- Duration of post- treatment incubation (in vitro):
- 120 minutes
- Number of animals or in vitro replicates:
- 3 replicates per test article or control
- Details on study design:
- SELECTION AND PREPARATION OF CORNEAS
: Bovine eyes from young cattle were obtained from the slaughterhouse (Vitelco, 's Hertogenbosch, The Netherlands), where the eyes were excised by a slaughterhouse employee as soon as possible after slaughter.
QUALITY CHECK OF THE ISOLATED CORNEAS : The eyes were checked for unacceptable defects, such as opacity, scratches, pigmentation and neovascularization by removing them from the physiological saline and holding them in the light. Those exhibiting defects were discarded.
NUMBER OF REPLICATES : 3
NEGATIVE CONTROL USED : Yes, physicological saline.
SOLVENT CONTROL USED: Not applicable
POSITIVE CONTROL USED : Yes, ethanol
APPLICATION DOSE AND EXPOSURE TIME : 750 uL for 10 minutes
TREATMENT METHOD: closed chamber
POST-INCUBATION PERIOD: yes, 120 minutes.
REMOVAL OF TEST SUBSTANCE
- Number of washing steps after exposure period: No data
- POST-EXPOSURE INCUBATION: Yes, 120 minutes
METHODS FOR MEASURED ENDPOINTS:
- Corneal opacity: The opacity of a cornea was measured by the diminution of light passing through the cornea. The light was measured as illuminance by a light meter.
- Corneal permeability: passage of sodium fluorescein dye measured with the aid of plate reader (OD490)
SCORING SYSTEM: In Vitro Irritancy Score (IVIS)
DECISION CRITERIA: OECD 437 criteria were utilized.
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- ca. -0.2
- 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
DEMONSTRATION OF TECHNICAL PROFICIENCY: Yes, the test method has been validated at the lab.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: Yes
- Acceptance criteria met for positive control: Yes
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Based on a mean IVIS of -0.2, the test article is not an ocular irritant.
- Executive summary:
The ocular irritation and corrosion potential of the test article was evaluated in the Bovine Corneal Opacity and Permeability test (BCOP). The study was conducted according to OECD 437 (2017) in compliance with OECD GLP regulations. The test article (750 uL) was applied to bovine corneas (n=3) undiluted. Positive (ethanol) and negative (physiological saline) controls were run in parallel (n=3). The isolated corneas were stored in a petri dish with cMEM (Earle’s Minimum Essential Medium (Life Technologies, Bleiswijk, The Netherlands) containing 1% (v/v) L-glutamine (Life Technologies) and 1% (v/v) Foetal Bovine Serum (Life Technologies)). The isolated corneas were mounted in a corneal holder (one cornea per holder) of BASF (Ludwigshafen, Germany) with the endothelial side against the O-ring of the posterior half of the holder. The anterior half of the holder was positioned on top of the cornea and tightened with screws. The compartments of the corneal holder were filled with cMEM at 32 C. The corneas were incubated for the minimum of 1 hour at 32 C. Following initial incubation, the medium from the anterior compartment was removed and the tissues were exposed (750 uL) to the test article or control for 10 minutes. Following exposure, the corneas were washed with MEM with phenol red and thereafter with cMEM. The medium in the posterior compartment was removed and both compartments were refilled with fresh cMEM. Subsequently, the corneas were incubated for 120 minutes at 32 C. After the completion of the incubation period, opacity determination was performed. Following opacity measurement, permeability of the cornea to Na-fluorescein was evaluated. The corneas treated with the test article showed opacity values ranging from -1.1 to 1.7 and permeability values ranging from -0.012 to -0.009. No pH effect of the test article was observed on the rinsing medium. The in vitro irritancy scores (IVIS) ranged from -1.3 to 1.5 following 10 minute exposure to the test article. Based on a mean IVIS of -0.2, the test article is not an ocular irritant.
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