Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
June 10, 2016 - August 29, 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 guideline
Qualifier:
according to guideline
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Taurine
EC Number:
203-483-8
EC Name:
Taurine
Cas Number:
107-35-7
Molecular formula:
C2H7NO3S
IUPAC Name:
2-aminoethanesulfonic acid
Test material form:
solid: crystalline
Specific details on test material used for the study:
Designation: Art. 808616
Synonym: Taurine
CAS-No.: 107-35-7
Batch: S6261016
Purity: 99.9% (acidimetric)
Appearance: White, crystalline powder
Minimum shelf life: September 30, 2020
Storage: Tightly closed, dry at +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, negative or positive control
Duration of treatment / exposure:
240 minutes
Number of animals or in vitro replicates:
in vitro: triplicate design

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
1
Value:
4
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
not determinable

Any other information on results incl. tables


Opacity
Permeability
IVIS
per cornea
per group
(mean value)
SD
Negative control
0.9% NaCl Solution
1.487
0.002
1.477
1.2
1.1
-0.131
-0.001
-0.106
2.067
0.000
2.102
Positive control
20% Imidazole solution
65.778
1.679
97.811
102.6
10.1
61.921
1.494
95.834
77.183
2.144
114.226
Test item
Art. 808616
3.671
0.004
3.725
4.0
1.1
2.967
0.008
3.081
5.110
0.005
5.183

Applicant's summary and conclusion

Interpretation of results:
other: could not be determined
Conclusions:
Under the conditions of the present study, the eye hazard potential of the test item Art. 808616 (Taurine) cannot be predicted.
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 eye hazard potential of the test item Art. 808616 (Taurine) cannot be predicted.