Registration Dossier
Registration Dossier
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EC number: 664-495-0 | CAS number: 740817-98-5
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- supporting study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Based in a patented in vtro EpiOcular t corneal model
- Data waiving:
- other justification
- Justification for data waiving:
- other:
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 006
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: MatTek Corporation EpiOcular in vitro toxicity testing system
- 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 vivo
Results
- Irritation parameter:
- other: Darize Score
- Time point:
- other: > 256 minutes
- Score:
- 0 - 15
- Max. score:
- 0
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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