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Diss Factsheets

Toxicological information

Eye irritation

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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:
2009

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

Constituent 1
Chemical structure
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

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.