Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
20 - 21 August 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report date:
2014

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 (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Trimethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane
EC Number:
288-657-1
EC Name:
Trimethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane
Cas Number:
85857-16-5
Molecular formula:
C11H13F13O3Si
IUPAC Name:
trimethoxy(3,3,4,4,5,5,6,6,7,7,8,8,8-tridecafluorooctyl)silane
Constituent 2
Reference substance name:
[2-(Perfluorohexyl)ethyl]trimethoxysilane
IUPAC Name:
[2-(Perfluorohexyl)ethyl]trimethoxysilane
Test material form:
other: liquid

Test animals / tissue source

Species:
other: Bovine
Strain:
not specified

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
RPMI medium used prior to treatment with test substance
Controls:
other: Three corneas of approximately median opacity readings after equilibration were used as negative controls. Three corneas were treated with 750 μl ethanol as positive control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 750 μl

CONTROLS
- Positive control substance: 100% ethanol
- Negative control substance physiological saline 0.9% NaCl


Duration of treatment / exposure:
10 minutes incubation at 32 ± 1°C
Observation period (in vivo):
Opacity measurement 2 hours after washing with MEM containing phenol red; optical density measured after 90 minutes incubation in medium with fluoroscein.
Number of animals or in vitro replicates:
3 corneas treated with test substance

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
other: opacity
Basis:
other: mean opacity change relative to control
Score:
0.33
Remarks on result:
other: not irritating
Irritation parameter:
other: permeability
Basis:
other: mean optical density at 490 nm relative to control
Score:
-0.004
Remarks on result:
other: not irritating
Irritation parameter:
other: In vitro irritation score
Basis:
other: opacity and permeability
Score:
0.27
Remarks on result:
other: Negative control score: 0.91; positive control score: 80.10; not irritating

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The eye irritancy potential of [2-(perfluorohexyl)ethyl]trimethoxysilane has been investigated in a valid in vitro bovine corneal opacity and permeability assay conducted in accordance with OECD 437 and in compliance with GLP. The following mean in vitro irritation score was calculated: 0.27. The in vitro irritation score obtained with the positive control fell within the two standard deviations of the current historical mean and therefore this assay is considered to be valid. It is concluded that the test substance is not irritating to the eye.