Registration Dossier
Registration Dossier
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EC number: 816-311-7 | CAS number: 76589-16-7
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 09 Nov 2017 - 21 Nov 2017
- 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)
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 2-methoxy-2-methylheptane
- EC Number:
- 816-311-7
- Cas Number:
- 76589-16-7
- Molecular formula:
- C9H20O
- IUPAC Name:
- 2-methoxy-2-methylheptane
- Test material form:
- liquid
Constituent 1
- Specific details on test material used for the study:
- Identification DAIKON ETHER
Chemical name (IUPAC), synonym or trade name 2-Methoxy-2-methylheptane
CAS Number 76589-16-7
Appearance Colourless liquid
Test item storage At room temperature
Test animals / tissue source
- Species:
- cattle
- Strain:
- not specified
- Details on test animals or tissues and environmental conditions:
- Bovine eyes from young cattle were obtained from the slaughterhouse
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µl
- Duration of treatment / exposure:
- 10 minutes
- Number of animals or in vitro replicates:
- Triplicate
- Details on study design:
- - Preparation of 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.
- Cornea Selection and Opacity Reading: Opacity determinations were performed on each of the corneas using an opacitometer.
- Test Item Preparation
- Treatment of Corneas and Opacity Measurements: The medium from the anterior compartment was removed and 750 l of either the negative control, positive control (Ethanol) or test item was introduced onto the epithelium of the cornea.
- Opacity Measurement: The opacity of a cornea was measured by the diminution of light passing through the cornea.
- Application of Sodium Fluorescein: Following the final opacity measurement, permeability of the cornea to Na-fluorescein was evaluated.
- Permeability Determinations: The optical density at 490 nm (OD490) of each sampling tube was measured in triplicate using a microplate reader.
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- Mean
- Value:
- 5.9
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: not specified
- Irritation parameter:
- other: Permeability Score
- Run / experiment:
- Mean
- Value:
- 0.137
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: not specified
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Mean
- Value:
- >= 6.3 - <= 9.2
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- no indication of irritation
- Other effects / acceptance of results:
- The negative control responses for opacity and permeability were less than the upper limits of the laboratory historical range indicating that the negative control did not induce irritancy on the corneas. The mean in vitro irritancy score of the positive control (Ethanol) was 47 and within two standard deviations of the current historical positive control mean. It was therefore concluded that the test conditions were adequate and that the test system functioned properly.
See atachment.
Applicant's summary and conclusion
- Interpretation of results:
- study cannot be used for classification
- Conclusions:
- In conclusion, since the test substance induced an IVIS > 3 ≤ 55, no prediction on the classification can be made.
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