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 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
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
Qualifier:
according to guideline
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. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Mandelic acid
EC Number:
202-007-6
EC Name:
Mandelic acid
Cas Number:
90-64-2
Molecular formula:
C8H8O3
IUPAC Name:
2-hydroxy-2-phenylacetic acid
Test material form:
solid
Specific details on test material used for the study:
Designation: Art. 806913
Synonym: DL-Mandelic acid for synthesis
Appearance: Solid
Minimum shelf life: May 31, 2020
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. 806913 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

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
Experiment 1 / Run 1
Value:
199.8
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
positive 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
1.487
-0.001
1.477
1.2
1.1
-0.131
0.002
-0.106
2.067
0.002
2.102
Positive control
20% Imidazole solution
65.778
2.136
97.811
102.6
10.1
61.921
2.261
95.834
77.183
2.470
114.226
Test item
Art. 806913
202.722
0.002
202.745
199.8
6.5
204.439
-0.003
204.397
192.282
0.003
192.330


Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
Under the conditions of the present study, Art. 806913 is inducing serious eye damage (UN GHS: Category 1).
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, Art. 806913 is inducing serious eye damage (UN GHS: Category 1).