Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017

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 material form:
liquid

Test animals / tissue source

Species:
cattle

Test system

Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
750 μL of the test substance or the control substance was introduced into the anterior chamber.
Duration of treatment / exposure:
After 10 minutes incubation at 32 ± 1 °C either the test substance or the control substance was removed and the epithelium washed at least three times with MEM (containing phenol red).
Number of animals or in vitro replicates:
3 corneas for the test item
3 corneas as negative controls treated with physiological saline 0.9% NaCl
3 corneas as positive controls treated with ethanol 100%

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
ca. 2.5
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The eye irritancy potential of TEA Trioleate was investigated in the bovine corneal opacity and permeability assay.
The test item was tested as provided by the sponsor.
All 3 corneas treated with TEA Trioleate showed complete opacity of the tissue.
The following mean in vitro irritation score was calculated: 2.50
Therefore the test item was classified into UN GHS No Category.
Executive summary:

The eye irritancy potential of TEA Trioleate was investigated in the bovine corneal opacity and permeability assay.

The test item was tested as provided by the sponsor.

All 3 corneas treated with TEA Trioleate showed complete opacity of the tissue.

The following mean in vitro irritation score was calculated: 2.50

Therefore the test item was classified into UN GHS No Category.

The in vitro irritation score obtained with the positive control is slightly increased (deviation of 0.8 SD) in comparison to the two standard deviations of the current historical mean. The deviation of the score did not influence the quality or integrity of the present study and therefore this assay is considered to be valid.

The negative control responses resulted in opacity and permeability values that are less than the established upper limits for background bovine corneas treated with the respective negative control.