Registration Dossier

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
December 2014
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2014
Report Date:
2014

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)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Type:
Constituent
Type:
impurity
Type:
impurity
Type:
impurity
Test material form:
liquid

Test animals / tissue source

Species:
cattle
Strain:
not specified
Details on test animals or tissues and environmental conditions:
Bovine cattle eyes were obtained from freshly slaughtered cattle at the abattoir EVA.

Test system

Vehicle:
unchanged (no vehicle)
Remarks:
As the test item is a non-surfactant-containing mixture, it will be tested undiluted (i.e. in its original form). Thus, no vehicle was used.
Controls:
yes
Amount / concentration applied:
750 μL (± 8 μL) for each cornea.
Duration of treatment / exposure:
10 minutes (± 30 seconds)
Duration of post- treatment incubation (in vitro):
Following the 10-minute treatment, the holders were incubated horizontally (corneas placed vertically) for 2 hours ± 10 minutes in a water bath at +32°C (± 1°C).

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Value:
1
Negative controls validity:
valid
Positive controls validity:
valid

Any other information on results incl. tables

All acceptance criteria were fulfilled. The study was therefore considered as valid. The mean In Vitro Irritancy Score (IVIS) was: 1.

As the test item induced a mean IVIS ≤ 3, the test item was considered as a test chemical not requiring classification for eye irritation or serious eye damage (UN GHS No Category).

Under the experimental conditions of this study, the test item, Jasmonyl, was identified as a test chemical not requiring classification for eye irritation or serious eye damage (UN GHS No Category).

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Jasmonyl does not require a classification for eye irritation or serious eye damage.
Executive summary:

Under the experimental conditions of this study, the test item, Jasmonyl, was identified as a test chemical not requiring classification for eye irritation or serious eye damage (UN GHS No Category).