Registration Dossier
Registration Dossier
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EC number: 686-853-5 | CAS number: 46921-17-9
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- weight of evidence
- Study period:
- december 2009
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- comparable to guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
- Report date:
- 2009
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
- Version / remarks:
- A statement is provide to compare the protocol of the study: “Assessment of the irritant potential of a test element after application to the isolated calf cornea”, carried out on December 3rd, 2009 by the laboratory EVIC France, with regard to OECD Guideline for In Vitro Eye Irritation N°437.
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- 4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole
- EC Number:
- 686-853-5
- Cas Number:
- 46921-17-9
- Molecular formula:
- C16H31NO
- IUPAC Name:
- 4,4-dimethyl-2-undecyl-4,5-dihydro-1,3-oxazole
- Reference substance name:
- Unknown impurities
- IUPAC Name:
- Unknown impurities
- Test material form:
- liquid
- Details on test material:
- Other name of 4,4-Dimethyl-2-undecyl-2-oxazoline : cycloceramide
Constituent 1
impurity 1
Test animals / tissue source
- Species:
- other: Calf
- Details on test animals or tissues and environmental conditions:
- Cornea of calves aged less than 8 monts, fresh and conserved
Test system
- Controls:
- yes, concurrent negative control
- Amount / concentration applied:
- 750 µl
- Duration of treatment / exposure:
- 30 min and 4 hours
- Observation period (in vivo):
- For opacity :
2 hours after the 30 minutes contact
Immediately after the 4 hours contact - Duration of post- treatment incubation (in vitro):
- 1h30 at 32 °C
- Number of animals or in vitro replicates:
- 3 corneas as negative control
3 cornea with test element - Details on study design:
- Incubation in a bain-marie (32°C) for each treatment.
At least 3 rinsing between the 2 treatments
Nutritive medium is used for control
Mesaurement of Corneal permeability is done after the two treatments and measurements of the opacity
Results and discussion
In vitro
Resultsopen allclose all
- Irritation parameter:
- cornea opacity score
- Remarks:
- 30 minutes
- Value:
- ca. -0.1
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
- Remarks:
- weakly irritant
- Irritation parameter:
- cornea opacity score
- Remarks:
- 4 hours
- Value:
- ca. 17.4
- Vehicle controls validity:
- valid
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- positive indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- Non eyes irritant substance
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