Registration Dossier
Registration Dossier
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EC number: 700-823-1 | CAS number: 55514-22-2
Eye irritation
Administrative data
- Endpoint:
- eye irritation
- Remarks:
- other: rabbit cornea
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- ?
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study performed according to GLP and French Official journal method (1999)
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 009
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other:
- Deviations:
- no
- Principles of method if other than guideline:
- Irritant potentiel determined by direct application of the substance on rabbit cornea fibroblast momolayer, by release of Neutral Red.
- GLP compliance:
- yes (incl. QA statement)
Test material
- Reference substance name:
- 3-[4-(5,6-diphenyl-1,2,4-triazin-3-yl)phenyl]-5,6-diphenyl-1,2,4-triazine
- EC Number:
- 700-823-1
- Cas Number:
- 55514-22-2
- Molecular formula:
- C36H24N6
- IUPAC Name:
- 3-[4-(5,6-diphenyl-1,2,4-triazin-3-yl)phenyl]-5,6-diphenyl-1,2,4-triazine
- Details on test material:
- - Name of test material (as cited in study report): WP30
- Physical state: powder
- Analytical purity: 99.6 %
- Purity test date: 23rd December 2008
- Lot/batch No.: LP110
- Stability under test conditions: stable
- Storage condition of test material: at room temperature in a dry and cool place
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- not specified
Test system
- Vehicle:
- other: Paraffinic oil
- Details on study design:
- WP30 was diluted at 10, 25, and 50 % in paraffinic oil for testing. Pure WP30 was tested also. Contact with test system was 60 seconds. A positive reference (SDS) was tested at 0.01, 0.05 and 0.2 %. Neutral red retention was measured after end of contact.
Test system was Predisafe kit:
cell line from Rabbit cornea
cell thawing: vials were thawed in a 37 °C water bath,. Cells were seeded in a 175 cm2 flask which was then placed in a water saturated incubator (0% CO2 and 100% air) during 6 or 7 days with culture medium renewal every 2 or 3 days.
cell seeding: same conditions, during 5 days.
Results and discussion
In vivo
- Irritant / corrosive response data:
- The highest cell mortality observed was at 50% concentration and was 3.5 %. This negligible cytotoxicity observed allows concluding lack of potential for rabbit cornea irritation.
Any other information on results incl. tables
Neutral red retention in controls was 1.022 (validity threshold: > 0.8)
The positive reference SDS gave CI50 > 0.01 % and < 0.2 %, that is within the acceptability range.
Applicant's summary and conclusion
- Interpretation of results:
- not irritating
- Remarks:
- Migrated information Criteria used for interpretation of results: expert judgment
- Conclusions:
- The negligible cytotoxicity observed allows concluding lack of potential for rabbit cornea irritation.
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