Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Report date:
2013

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
3-(3,4,5-trimethoxybenzylidene)pentane-2,4-dione
EC Number:
807-059-9
Cas Number:
945558-97-4
Molecular formula:
C15H18O5
IUPAC Name:
3-(3,4,5-trimethoxybenzylidene)pentane-2,4-dione

Test animals / tissue source

Species:
other: bovine corneal

Test system

Vehicle:
physiological saline
Controls:
yes
Amount / concentration applied:
0.75 ml of a 20% solution Synoxyl HSS in 0.9% Sodium Saline Irrigation
Duration of treatment / exposure:
4 h
Number of animals or in vitro replicates:
3
Details on study design:
Three bovine corneas per group were dosed with 0.75 ml of a 20% solution Synoxyl HSS in 0.9% Sodium Saline Irrigation, vehicle controls were dosed with 0.9% Sodium Chloride Irrigation, negative controls were dosed with Minimal Essential Media (MEM) and positive controls were dosed with a 20% solution of Imidazole in MEM. Following a four-hour exposure for each group of dosed corneas, opacity measurements and sodium fluorescein permeability were determined.

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
11.8
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Test Article: The corrected mean opacity score was 12.03. The corrected mean optical density (permeability) score was -0.017. The in vitro irritancy score (IVIS) was calculated as 11.8.

Vehicle Control: The corrected mean opacity score was -0.37. The corrected mean optical density (permeability) score was -0.035. The in vitro irritancy score (IVIS) was calculated as -0.89.

Negative Control: The corrected mean opacity score was 1.67. The mean optical density (permeability) score was 0.064. The in vitro irritancy score (IVIS) was calculated as 2.6.

Positive Control: The corrected mean opacity score was 85.3. The corrected mean optical density (permeability) score was 0.863. The in vitro irritancy score (IVIS) was calculated as 98.2.

Applicant's summary and conclusion

Interpretation of results:
other: Non-corrosive or sever irritant
Conclusions:
OECD guideline #437 defines substance that produces an IVIS score of >55.1 as corrosive or severe irritant. IVIS <55.1 is not a corrosive or severe irritant. IVIS score for Synoxyl HSS is found to be 11.8. Synoxyl HSS at concentrations tested may be considered to be Non-corrosive or sever irritant.