Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- August 1, 2017 - October 17, 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:
- 2013
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
- Version / remarks:
- Commission Regulation (EU) 2017/735 of 14 February 2017 amending, for the purpose of its adaption to technical progress, the Annex to Regulation (EC) No 440/2008 laying down test methods pursuant to Regulation (EC) No 1907/2006 of the European Parliament and the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH).
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 4-(Difluoro-(3,4,5-trifluoro-phenoxy)-methyl)-3,5-difluoro-benzaldehyde
- Cas Number:
- 685563-70-6
- Molecular formula:
- C14H5F7O2
- IUPAC Name:
- 4-(Difluoro-(3,4,5-trifluoro-phenoxy)-methyl)-3,5-difluoro-benzaldehyde
- Test material form:
- solid: crystalline
Constituent 1
Test system
- Vehicle:
- physiological saline
- Controls:
- yes, concurrent vehicle
- yes, concurrent positive control
- Amount / concentration applied:
- TEST MATERIAL: 750 µL (i.e. 150 mg/750 µL)
NEGATIVE / VEHICLE CONTROL: 750 µL
Designation: 0.9 % sodium chloride solution
Supplier: B. Braun Melsungen AG, Germany
Batch: 16455011
Storage: 2 to 8 °C
Released until: October 2019
POSITIVE CONTROL: 750 µL
Synonym: Imidazole
Imidazole was dissolved with 0.9 % sodium chloride solution to a concentration of 20 % (w/v). - Duration of treatment / exposure:
- 240 minutes
- Number of animals or in vitro replicates:
- in vitro: triplicate design
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Run / experiment:
- Run 1 / Experiment 1
- Value:
- 13.3
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Other effects / acceptance of results:
- OTHER EFFECTS:
- Visible damage on test system: No observations (e.g. tissue peeling, residual test chemical, non-uniform opacity patterns) were seen in a visually inspection of the corneas after treatment.
ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: After treatment with the negative control (0.9% sodium chloride solution) the calculated IVIS was 0.1 and, thus, within three standard deviations of the current historical mean of the negative control (IVIS: -1.4 – 3.2).
- Acceptance criteria met for positive control: After treatment with the positive control (20% Imidazole) the calculated IVIS was 112.1 and, thus, also within two standard deviations of the current historical mean of the positive control (IVIS: 80.9 – 133.0).
Therefore, the study fulfilled the acceptance criteria.
Any other information on results incl. tables
| Opacity | Permeability | IVIS | ||||
| per cornea | per group (mean value) | SD | ||||
| Negative control | 0.9 % NaCl Solution | 0.3 | -0.005 | 0.225 | 0.1 | 0.6 |
| -0.4 | -0.006 | -0.490 | ||||
| 0.7 | -0.005 | 0.625 | ||||
| Positive control | 20 % Imidazole solution | 77 .0 | 2.077 | 108.155 | 112.1 | 9.4 |
| 65.0 | 2.689 | 105.335 | ||||
| 73.4 | 3.295 | 122.825 | ||||
| Test item | 12.9 | 0.015 | 13.125 | 13.3 | 0.7 | |
| 12.6 | 0.009 | 12.735 | ||||
| 14.6 | 0.005 | 14.175 | ||||
Applicant's summary and conclusion
- Interpretation of results:
- other:
- Remarks:
- The IVIS obtained after treatment with the test item was 13.3 and, thus higher than 3 and lower than 55, i.e. according to OECD 437 no prediction can be made regarding the eye hazard potential of the test item.
- Conclusions:
- Under the conditions of the present study, the eye hazard potential of the test item cannot be predicted.
- Executive summary:
This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. The IVIS obtained after treatment with the test item was 13.3 and, thus higher than 3 and lower than 55, i.e. according to OECD 437 no prediction can be made regarding the eye hazard potential of the test item.
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