Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2011-03-24 to 2011-03-25
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report date:
2011

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Version / remarks:
2009-09-07
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
-
EC Number:
442-650-1
EC Name:
-
Cas Number:
56450-90-9
Molecular formula:
F4Mg5Na2O20Si8
IUPAC Name:
silanedione hydrofluoride magnesium dihydride sodium hydride
Test material form:
solid: particulate/powder
Details on test material:
One sample of Sodium Magnesium Fluoride Silicate, Lot No. 91107
EINECS# 442-650-1
CAS# 56450-90-9
Sample submission date: 16.11.2009
Specific details on test material used for the study:
SOURCE OF TEST MATERIAL
- Source and lot/batch No.of test material: Topy Indsutries Ltd. / 91108
- Expiration date of the lot/batch: 2014-11-20

STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Stability under test conditions: stable
- Solubility and stability of the test substance in the solvent/vehicle: soluble and stable
- Reactivity of the test substance with the solvent/vehicle of the cell culture medium: none

TREATMENT OF TEST MATERIAL PRIOR TO TESTING
- Treatment of test material prior to testing: no
- Final preparation of a solid: No preparartion before administered

Test animals / tissue source

Species:
chicken
Details on test animals or tissues and environmental conditions:
SOURCE OF COLLECTED EYES
- Source: Gold Chic Poultry Supply Pte Ltd.
- Number of animals: 7 eyes
- Storage, temperature and transport conditions of ocular tissue (e.g. transport time, transport media and temperature, and other conditions): chilled
- indication of any existing defects or lesions in ocular tissue samples: no

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 0.03 g per eye
Duration of treatment / exposure:
10 secinds. Max. 240 min observation period
Number of animals or in vitro replicates:
3 replicates of test item (magnesium sodium fluoride silicate) and positive control, 1 replicate negtaive control
Details on study design:
SELECTION AND PREPARATION OF CORNEAS
The eyelids were excised without damage of the cornea.
The undamaged eyes were then be dissected from the skull. The dissected eyes were placed on an abosrbant pad, the nictiating membrane and other connective tissue were removed.
The selected eyes were mounted in the stainless steel clamps with the cornea positioned vertically. The clamps were transferred into the chamber of the superfusion apparatus. The clamps were positioned such that the entire cornea was supplied with saline drip. The temperature of the chambers of the superfusion apparatus were controlled at 32 ± 1.5 °C.

QUALITY CHECK OF THE ISOLATED CORNEAS
Corneal integrity was assessed with a drop of 2% (w/v) sodium fluorescein applied to the corneal surface for a few seconds, and then rinsed with saline. Fluorescein-treated eyes were then examined with slit lamp to ensure that the cornea was undamaged.

NUMBER OF REPLICATES
3 replicates of test item (magnesium sodium fluoride silicate) and positive control, 1 replicate negtaive control

NEGATIVE CONTROL USED
0.9 % NaCL solution

POSITIVE CONTROL USED
NaOH

APPLICATION DOSE AND EXPOSURE TIME
0.03.g, 10 seconds

SCORING SYSTEM:
Mean corneal opacity value, mean flurescin retention score

DECISION CRITERIA: please specify if the decision criteria as indicated in the TG was used. Yes

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Value:
1.3
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
fluorescein retention score
Value:
1
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
OTHER EFFECTS:
- Visible damage on test system: No adverse morphological effect was observed

ACCEPTANCE OF RESULTS:
- Acceptance criteria met for negative control: yes
- Acceptance criteria met for positive control: yes

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Under the condition of this study, magnesium sodium fluoride silicate is not considered as ocular corrosive or severe irritant using Isolated Chicken Eye Test Method.
Executive summary:

Under the condition of this study, magnesium sodium fluoride silicate is not considered as ocular corrosive or severe irritant using Isolated Chicken Eye Test Method.