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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
October 2018
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
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)
Version / remarks:
2018
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
2-[2,4-bis(tert-pentyl)phenoxy]-N-(3,5-dichloro-4-ethyl-2-hydroxyphenyl)butyramide
EC Number:
300-634-0
EC Name:
2-[2,4-bis(tert-pentyl)phenoxy]-N-(3,5-dichloro-4-ethyl-2-hydroxyphenyl)butyramide
Cas Number:
93951-12-3
Molecular formula:
C28H39Cl2NO3
IUPAC Name:
2-[2,4-bis(tert-pentyl)phenoxy]-N-(3,5-dichloro-4-ethyl-2-hydroxyphenyl)butyramide
Test material form:
solid
Details on test material:
Batch 44029
colour : White to off-white
retest date : 01/06/2019
Specific details on test material used for the study:
Controlled room temperature (15-25°C, <70% relative humidity), protected from light and humidity (stored in a tightly closed container)

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent positive control
yes, concurrent negative control
Amount / concentration applied:
The test item was applied in its original form (although it was grounded to fine powder).
the eye was held in horizontal position and 30 mg powdered test item was applied onto the centre of the cornea in such a way that the entire surface of the cornea was covered.
Duration of treatment / exposure:
After an exposure period of 10 seconds, the surface was rinsed with physiological saline.
Duration of post- treatment incubation (in vitro):
The control eyes and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse. Minor variations within approximately ±5 minutes were considered acceptable.
Number of animals or in vitro replicates:
2 experiments
In each experiment, three test item treated eyes, three positive control treated eyes and one negative control treated eye were examined.
Details on study design:
Chicken heads were collected after slaughter in a commercial abattoir from chickens (approximately 7 weeks old) which are used for human consumption.
The eye ball was carefully removed from the orbit by holding the nictitating membrane with a surgical forceps, while cutting the eye muscles with bent scissors. Care was taken to remove the eyeball from the orbit without cutting off the optical nerve too short. The procedure avoided pressure on the eye while removing the eyeball from the orbit, in order to prevent distortion of the cornea and subsequent corneal opacity. Once removed from the orbit, the eye was placed onto damp paper and the nictitating membrane was cut away with other connective tissue. The prepared eyes were kept on the wet papers in a closed box so that the appropriate humidity was maintained.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
percent corneal swelling
Remarks:
at up to 75 min
Run / experiment:
1
Value:
0.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
percent corneal swelling
Remarks:
at up to 240 min
Run / experiment:
1
Value:
0.5
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Run / experiment:
1
Value:
0.17
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
other: fluorescein retention
Run / experiment:
1
Value:
0
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
percent corneal swelling
Remarks:
at up to 75 min
Run / experiment:
2
Value:
0
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
percent corneal swelling
Remarks:
at up to 240 min
Run / experiment:
2
Value:
0
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Run / experiment:
2
Value:
0.33
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Irritation parameter:
other: fluorescein retention
Run / experiment:
2
Value:
0
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
valid
Remarks on result:
no indication of irritation
Other effects / acceptance of results:
Experiment I : Test item was stuck on one cornea surface after the post-treatment rinse. The cornea surface was cleared at 75 minutes after the post-treatment rinse.
Exepriment II : none

Any other information on results incl. tables

VALIDITY OF THE TEST

The results from all eyes used met the quality control standards. The negative control and positive control results were within the historical data range in each experiment. This study was considered to be valid.

MORPHOLOGICAL EFFECTS

In the first experiment, the test item was stuck on one cornea surface after the post-treatment rinse. The cornea surface was cleared at 75 minutes after the post-treatment rinse.

In each experiment, positive control material was stuck on all cornea surfaces after the post-treatment rinse, the cornea surfaces (3/3) were not cleared at 240 minutes after the post-treatment rinse.

No other morphological effect was observed in the study.

DEVIATIONS TO THE STUDY PLAN

There was no deviation to the Study Plan.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on these in vitro eye irritation assays in isolated chicken eyes with the substance, the test item was non-irritant, UN GHS Classification: No Category.
Executive summary:

An in vitro eye irritation study of the test item was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No. 438 guideline (25 June 2018).

In each experiment after the zero reference measurements, the eye was held in horizontal position and 30 mg powdered test item was applied onto the centre of the cornea in such a way that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with physiological saline. Positive control eyes were treated with 30 mg powdered Imidazole. The negative control eye was treated with 30 μL of physiological saline (0.9% (w/v) NaCl solution). In each experiment, three test item treated eyes, three positive control treated eyes and one negative control treated eye were examined.

The results from all eyes used in the study met the quality control standards. The negative control and positive control results were within the historical control data range in each experiment. Thus, the study was considered to be valid.

Experiment I: No significant corneal swelling was observed during the four-hour observation period on test item treated eyes. No significant cornea opacity change and no fluorescein retention change was observed on all three eyes. Test item was stuck on one cornea surface after the post-treatment rinse. The cornea surface was cleared at 75 minutes after the post-treatment rinse.

Experiment II: No corneal swelling was observed during the four-hour observation period on test item treated eyes. No significant cornea opacity change was observed on all three eyes. No fluorescein retention change was noted on all three eyes. No other corneal effects were observed.