Registration Dossier
Registration Dossier
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EC number: 256-190-2 | CAS number: 45103-58-0
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 22/03/2018-21/06/2018
- 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)
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 2-(2-methoxyethoxy)ethyl methacrylate
- EC Number:
- 256-190-2
- EC Name:
- 2-(2-methoxyethoxy)ethyl methacrylate
- Cas Number:
- 45103-58-0
- Molecular formula:
- C9H16O4
- IUPAC Name:
- 2-(2-methoxyethoxy)ethyl 2-methylprop-2-enoate
- Test material form:
- liquid
Constituent 1
Test system
- Vehicle:
- unchanged (no vehicle)
- Controls:
- yes, concurrent positive control
- yes, concurrent negative control
- Amount / concentration applied:
- 0.75 ml
- Duration of treatment / exposure:
- 10 minutes exposure
- Duration of post- treatment incubation (in vitro):
- - two hours after anterior and posterior chambers of the holders were then refilled with fresh MEM solution
- 90±5 minutes with sodium fluorescein solution
- Each holder was then returned to the 32±1°C incubator in a horizontal position (anterior side up) ensuring
contact of the fluorescein with the cornea for 90 minutes - Number of animals or in vitro replicates:
- 3
Results and discussion
In vitro
Results
- Irritation parameter:
- in vitro irritation score
- Value:
- 11.33
- Negative controls validity:
- valid
- Remarks:
- IVIS=0.17
- Positive controls validity:
- valid
- Remarks:
- IVIS=30.51
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The BCOP IVIS was 11.33, the corrected mean opacity score was 10.67, and the corrected mean optical density (permeability) score was 0.044. Because the IVIS was less than 55, this result indicated that the test article did not cause serious eye damage, thereby ruling out GHS Category 1.
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