Registration Dossier
Registration Dossier
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EC number: 830-086-2 | CAS number: 742087-48-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
- Justification for type of information:
- SugaNate 160NC has been used in this end point as a read-across substance for SugaNate 100NC. A comparison of the two substances and a read-across justification can be found in section 13 of this dataset.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)
- Deviations:
- not specified
- Principles of method if other than guideline:
- "MatTek patented EpicOcular cornela Model consists of normal , human derived epidermal keratocytes which hava been cultured to form a stratified , squamous epithelium similar to that found in the cornea.The epdidermal cells , which are cultured on specially prepared cell culture inserts using serum free medium , differentiate to form a mutilayered structure which closely parallels the corneal epithelium.
- GLP compliance:
- not specified
Test material
- Reference substance name:
- Suga®Nate 160
- IUPAC Name:
- Suga®Nate 160
- Details on test material:
- The test article is diluted in distilled water (1/4) and concentration dose was 20%.
Referenence article:Triton X100(0.3%)
Negative control (distilled water)
EpiOcular samples were incobated 37ºC (5% carbon dioxide, and >= 90% humidity)
Constituent 1
Test system
- Vehicle:
- water
- Controls:
- not required
- Duration of treatment / exposure:
- 10 minutes
- Observation period (in vivo):
- 3 hours
- Number of animals or in vitro replicates:
- not applicable (in vitro analysis
Results and discussion
In vitro
Results
- Irritation parameter:
- other: Draize score
- Remarks:
- The patented EpiOcular in vitro method used cnverts the readings obtained back to what would have been recorded via the Draize method
- Run / experiment:
- The EpiOcular ET-50 time recorded of >256 minutes converts back to a 0 - 15 Driaze score - see attached report for full explanation
- Value:
- > 0 - <= 15
- Remarks on result:
- no indication of irritation
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: other: Rabbit Draize eye score
- Conclusions:
- Under the conditions of this test,the results indicate that Colonial SugaNate 160 (10%) Active test article , at 100% ,has a " non-irritating" classification
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