Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
April - May 2015
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report Date:
2016

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Version / remarks:
26 July 2013
Deviations:
no
Qualifier:
according to
Guideline:
other: OECD series on testing and assessment no. 160
Deviations:
no
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
liquid
Details on test material:
- State of aggregation: Clear colorless liquid
- Storage Conditions: Room temperature, in the dark

Test animals / tissue source

Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Test system: isolated corneas from the eyes of freshly slaughtered bovine.
Age of animals: 6-12 months
Transport solution: Hanks balanced salt solution (HBSS) Modified supplemented with Penicillin sulphate and Streptomycin
sulphate.
Transport conditions: in transport solution at approximately 4°C.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
0.750 mL of the test item was tested as supplied (being a liquid non surfactant) on the epithelial surface of three idoneous bovine corneas.
Duration of treatment / exposure:
Corneas were exposed in horizontal position for an exposure period of 10 minutes.
Duration of post- treatment incubation (in vitro):
2 hours
Details on study design:
Positive control item was 100% (v/v) dimethylformamide (Labelled as N,NDimethylformamide, Sigma, batch no. SZBD0800V).
Negative control item was Physiological saline (0.9% NaCl) (Baxter, batch no. 13D0406).
Volume of treatment: 0,75 mL
Number of replicates: 3

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
in vitro irritation score
Run / experiment:
mean
Value:
0.3
Negative controls validity:
valid
Positive controls validity:
valid
Remarks:
95.5
Irritation parameter:
cornea opacity score
Run / experiment:
mean
Value:
0
Negative controls validity:
valid
Remarks:
0.0
Positive controls validity:
valid
Remarks:
82.3
Irritation parameter:
other: calculated permeability
Run / experiment:
mean
Value:
0.019
Negative controls validity:
valid
Remarks:
0.0067
Positive controls validity:
valid
Remarks:
0.8823
Other effects / acceptance of results:
At the macroscopic observation, no visible change of the treated corneas was noted.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results of an in vitro eye irritancy test performed according to OECD/EC guidelines and GLP principles, it is concluded that Sakura Salicylate is non corrosive or irritant to the eye.
Executive summary:

The potential of Sakura Salicylate to cause corrosion/ severe irritation was tested by using the Bovine Corneal Opacity and Permeability (BCOP) assay, according to OECD/EC guidelines and GLP principles. The test item was tested as supplied (being a liquid non surfactant) on the epithelial surface of three idoneous bovine corneas. Positive and negative controls (100% (v/v) dimethylformamide and physiological saline alone, respectively) were concurrently tested in the same number of replicates. The mean opacity of the corneas treated with the test item, detected with an opacitometer at the end of the 2-hour post-exposure period, was 0.0. At the macroscopic observation, no visible change of the treated corneas was noted. After the determination of opacity, the epithelial surface was treated with a 0.4% solution of sodium fluorescein in DPBS for 90 minutes, to investigate alteration in cornea permeability. The calculated mean permeability OD490 value of the corneas treated with the test item was 0.0190. The calculated in vitro irritancy score (IVIS) for the test item was 0.3. Negative and positive controls gave the expected results. Based on these results it is concluded that the test item is non corrosive or irritant to the eye, and is not classified for eye irritancy according to Regulation (EC) 1272/2008.