Registration Dossier

Administrative data

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

Data source

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

Materials and methods

Test guidelineopen allclose all
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)
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
Type:
Constituent
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid
Details on test material:
UVCB substance
Specific details on test material used for the study:
Batch: PE00138468

Test animals / tissue source

Species:
cattle
Strain:
other: Bos primigenius Taurus

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
Negative control HBSS solution, Positive control Dimethylformamide (undiluted)
Controls:
yes
Amount / concentration applied:
The respective substance (negative control solution, test item or positive control) was applied by pipetting 750 μL of the appropriate liquid through the refill hole in the holder on the cornea. The test item was given on the epithelium in such a manner that as much as possible of the cornea was covered with the test item.
Duration of treatment / exposure:
Exposure time on the corneas was 10 minutes at 32 ± 1 °C.
Duration of post- treatment incubation (in vitro):
After thorough rinsing with cMEM with phenol red and final rinsing with cMEM without phenol red, the anterior chamber was filled with cMEM without phenol red, and the corneas were stored for additional 2 hours at 32 ± 1 °C (post-incubation).

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
Mean
Value:
1.93
Vehicle controls validity:
valid
Negative controls validity:
valid
Positive controls validity:
valid

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Jasmonyl LG is not irritating to the eye.
Executive summary:

This in vitro study was performed to assess corneal damage potential of Jasmonyl LG by quantitative measurements of changes in opacity and permeability in a bovine cornea.

The test item Jasmonyl LG was brought onto the cornea of a bovine eye which previously had been incubated with cMEM without phenol red at 32 ± 1 °C for 1 hour and whose opacity had been determined. 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.

The test item was tested pure.

Under the conditions of this test, the test item Jasmonyl LG showed no effects on the cornea of the bovine eye. The calculated IVIS (in vitro irritancy score) is 1.93.

According to OECD Guideline no. 437 (Jul. 2013), a substance with an IVIS ≤ 3 requires no classification for eye irritation or serious eye damage.

The negative control (HBSS-solution) and the positive control (undiluted dimethylformamide) have met the validity criteria.

No observations were made which might cause doubts concerning the validity of the study outcome. The test is considered valid.