Registration Dossier

Administrative data

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

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018
Report Date:
2018

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed

Test animals / tissue source

Species:
other: Bovine corneas
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Bovine corneas were used. They were collected from slaughtered cattle which were be-tween 12 and 60 months old.

Test system

Controls:
yes, concurrent positive control
yes, concurrent negative control
Duration of treatment / exposure:
The test item was incubated on the cornea for 10 minutes at 32 ± 1 °C. After removal of the test item and 2 hours post-incubation, opacity and permeability values were measured.

Results and discussion

In vitro

Results
Irritation parameter:
cornea opacity score
Value:
0.061
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

Optical density at 492 nm of Negative Control, Test Item and Positive Control

Parameter

Negative Control

Test Item

Positive Control

1. Measurement

0.076

0.054

0.059

0.050

0.127

0.190

0.851

0.751

0.739

2. Measurement

0.075

0.053

0.056

0.050

0.127

0.188

0.840

0.743

0.738

3. Measurement

0.080

0.053

0.052

0.051

0.131

0.189

0.852

0.752

0.744

 

1. Measurement – blank

0.0417

0.0197

0.0247

0.0157

0.0927

0.1557

0.8167

0.7167

0.7047

2. Measurement – blank

0.0407

0.0187

0.0217

0.0157

0.0927

0.1537

0.8057

0.7087

0.7037

3. Measurement – blank

0.0457

0.0187

0.0177

0.0167

0.0967

0.1547

0.8177

0.7177

0.7097

Mean of each replicate

0.0427

0.0190

0.0213

0.0160

0.0940

0.1547

0.8133

0.7143

0.7060

Mean of the

3 replicates

0.0277

--

--

Corrected

--

--

--

-0.0117

0.0663

0.1270

0.7857

0.6867

0.6783

Corrected mean of the

3 replicates

--

0.0606

0.7169

IVIS The calculated IVIS for each replicate and the corresponding means are presented in the following table:

Test Group

IVIS

Mean IVIS

Relative Standard Deviation IVIS

Negative Control
HBSS

1.37

0.92

43.55%

0.75

0.62

Test Item
Ginger, ext.

0.75

0.98

95.75%

0.18

2.02

Positive Control
DMF undiluted

66.90

68.75

2.39%

70.05

69.30

Applicant's summary and conclusion

Conclusions:
no classification for eye irritation or serious eye damage.