Disodium hexafluorosilicate

Eye irritation

Administrative data

Endpoint:

eye irritation

Remarks:

other: in vitro

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2010

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

other: OECD guideline no. 437

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Disodium hexafluorosilicate

EC Number:

240-934-8

EC Name:

Disodium hexafluorosilicate

Cas Number:

16893-85-9

Molecular formula:

F6Si.2Na

IUPAC Name:

disodium hexafluorosilicate

Test system

Vehicle:

other: PEG400

Controls:

other: positive and negative controls were used

Amount / concentration applied:

20% (w/v) concentration in PEG 400

Duration of treatment / exposure:

Corneas were exposed for 4 hours

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing (if done): After exposure, corneas were rinsed thoroughly with EMEM with phenol red.
- Time after start of exposure: 4h

SCORING SYSTEM: IVIS = opacity + (15 x Permeability OD490 value)

TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope / fluorescein

Results and discussion

In vivo

Results

Irritation parameter:

other: IVIS

Score:

ca. 15.6

Irritant / corrosive response data:

Eyes were examined for the presence of any defects which render the eye unsuitable for use (opacity, scratches or pitting of the corneal surface, vascularisation or pigmentation).
The permeability of the corneas (0.1347) was higher than that of negative control (0.0097), but lower than the value recorded for the vehicle (0.9797).This may indicate that the test item presence may have protected the corneas from the increase of permeability due to PEG 400 vehicle.

Any other information on results incl. tables

Treatment code		Opacity Value		Macroscopic observation		OD490
N1		1		No macroscopic changes		0.004
N2		2		No macroscopic changes		0.015
N3		1		No macroscopic changes		0.010
	Mean	1.3			Mean	0.0097
	SD	0.6			SD	0.0055
	CV %	46.2			CV %	56.70
P1		42		Cornea totally opaque; slight exfoliation		1.631
P2		63		Cornea totally opaque; slight exfoliation		1.357
P3		40		Cornea totally opaque; slight exfoliation		1.970
	Mean	48.3			Mean	1.6527
	SD	12.7			SD	0.3071
	CV %	26.3			CV %	18.58
Corrected Mean		47.0		Corrected Mean		1.6430
(negative control)				(negative control)
A1		8		Irregular opacity; presence of precipitate		0.168
A2		5		Irregular opacity; presence of precipitate		0.158
A3		6		Irregular opacity; presence of precipitate		0.078
	Mean	6.3			Mean	0.1347
	SD	1.5			SD	0.0493
	CV %	23.8			CV %	36.60
Corrected Mean		5.0		Corrected Mean		0.1250
(negative control)				(negative control)
B1		2		Slightly irregular opacity pattern		1.018
B2		4		Slightly irregular opacity pattern		0.919
B3		1		Slightly irregular opacity pattern		1.002
	Mean	2.3			Mean	0.9797
	SD	1.5			SD	0.0531
	CV %	65.2			CV %	5.42
Corrected Mean		1.0		Corrected Mean		0.9700
(negative control)				(negative control)

Applicant's summary and conclusion

Interpretation of results:

other: potential slight irritant

Remarks:

Criteria used for interpretation of results: OECD GHS

Conclusions:

According to the criteria stated in the OECD guideline for this test, the test item is not defined as corrosive or severely irritant to the eye.

Executive summary:

Opacity and permeability of all corneas were determined. The treatment with the test item induced a very slight effect on corneal opacity and permeability. However, on one hand the physical nature of the test item may have affected the opacity while, on the other hand, the vehicle used may have influenced the permeability alteration of the test system.