Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 17, 2016 - August 12, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
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)
Deviations:
no
Qualifier:
according to
Guideline:
EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Specific details on test material used for the study:
Designation: Art. 201386
Synonym: B-2O-O5
Batch: EF13004186
Purity (HPLC): 100.0%
Appearance: White, solid
Expiry date: April 30, 2018
Storage: Tightly closed, dark at room temperature (15 to 25°C)


Test system

Vehicle:
physiological saline
Controls:
yes, concurrent vehicle
yes, concurrent positive control
Amount / concentration applied:
750 µL (i.e. 150mg/750µL) of test item preparation, negative or positive control.

The test item Art. 201386 (B-2O-O5) was prepared as a 20% (w/v) suspension in a 0.9% sodium chloride solution. The stability in the vehicle was not investigated. The test item preparation was administered within <1 hour after preparation.
Duration of treatment / exposure:
240 minutes
Number of animals or in vitro replicates:
in vitro: triplicate design

Results and discussion

Results of ex vivo / in vitro study
Irritation parameter:
in vitro irritation score
Run / experiment:
Experiment 1 / Run 1
Value:
0.3
Vehicle controls valid:
yes
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
no indication of irritation

Any other information on results incl. tables


Opacity
Permeability
IVIS
per cornea
per group
(mean value)
SD
Negative control
0.9% NaCl Solution
1.288
-0.002
1.258
2.1
2.0
0.645
-0.003
0.595
4.371
0.000
4.371
Positive control
20% Imidazole solution
82.221
1.884
110.487
115.4
5.1
82.364
2.182
115.096
80.799
2.657
120.651
Test item
Art. 201386
0.700
0.001
0.712
0.3
0.4
0.168
0.005
0.245
-0.108
0.001
-0.087


Applicant's summary and conclusion

Interpretation of results:
other:
Remarks:
UN GHS: No Category (according to OECD TG 437)
Conclusions:
Under the conditions of the present study, the test item Art. 201386 (B-2O-O5) did not show an eye hazard potential. The test item is not requiring classification for eye irritation or serious eye damage (UN GHS: No Category).
Executive summary:

This study was performed according to GLP and the methods applied are fully compliant with OECD TG 437. Under the conditions of the present study, the test item Art. 201386 (B-2O-O5) did not show an eye hazard potential. The test item is not requiring classification for eye irritation or serious eye damage (UN GHS: No Category).