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Toxicological information

Eye irritation

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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:
2013
Report Date:
2013

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Details on test material:
Test item: N-(2-HYDROXYETHYL) PHTHALIMIDE
CAS No.: 3891-07-4
Physical state: solid, powder
Colour and Odour: white, odourless
Active Ingredient Content (TLC): 98.95 %
Storage: on dry place, protected from light, 15-30 °C

Test animals / tissue source

Species:
other: Chicken eye
Details on test animals or tissues and environmental conditions:
Chicken heads collection and transport:
Species of chicken: COBB 500. The heads were transported to TOXI-COOP ZRT. at the earliest convenience for use approximately within 2 hours from collection. All eyes used in the assay were from the same groups of eyes collected on one specific day.
After collection, the heads were inspected for appropriate quality and wrapped with paper moistened with saline, then placed in a plastic box that can be closed (4-5 heads/box).
Eyes selection:
After removing the head from the plastic box, it was put on soft paper. The eyelids were carefully cut away with scissors, avoiding damaging the cornea. If the cornea was in good condition, the eyeball was carefully removed from the orbit.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes
Amount / concentration applied:
Three test item were treated with 0.03g/eye N-(2-hydroxyethyl)phthalimide.
The three positive control eyes were treated in a similar way with 0.03 g Imidazole.
One negative control eye was treated with saline solution.
Duration of treatment / exposure:
The time of application was monitored, then after an exposure period of 10 seconds from the end of the application the cornea surface was rinsed thoroughly with 20 mL saline solution at ambient temperature, while taking care not to damage the cornea but attempting to remove all the residual test item if possible.
Observation period (in vivo):
The control 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 ±5 minutes were considered acceptable.
The cornea thickness and cornea opacity were measured at all time points. Fluorescein retention was determined at baseline (t=0) and 30 minutes after the post-treatment rinse.
Number of animals or in vitro replicates:
Three test item treated eyes, three positive control eyes and one negative control eye were used in this study.
Details on study design:
The purpose of this Isolated Chicken Eye Test (ICET) was to evaluate the potential ocular corrosivity or severe irritancy of the test item N-(2-HYDROXYETHYL) PHTHALIMIDE (CAS 3891-07-4) by its ability to induce toxicity in enucleated chicken eyes. Each eye which was used in this study was collected in the slaughterhouse, eliminating the need for laboratory animals. The test compound was applied in a single dose onto the cornea of isolated chicken eyes in order to potentially classify the test compound as ocular corrosive and/or severe irritant. The damage by the test substance was assessed by determination of corneal swelling, opacity, fluorescein retention and morphological effects. These parameters were evaluated pre-treatment and starting at approximately 30, 75, 120, 180, and 240 minutes after the post-treatment rinse. The endpoints evaluated were corneal opacity, swelling, fluorescein retention, and morphological effects. All of the endpoints, with the exception of fluorescein retention (which was determined only at pre-treatment and 30 minutes after test substance exposure) were determined at each of the above time points.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
percent corneal swelling
Run / experiment:
up to 75 min
Value:
5
Irritation parameter:
percent corneal swelling
Run / experiment:
up to 240 min
Value:
6
Irritation parameter:
cornea opacity score
Value:
0.7
Irritation parameter:
fluorescein retention score
Value:
0

Any other information on results incl. tables

Observation

Value

ICE Class

Mean maximum corneal swelling at up to 75 min

5 %

I

Mean maximum corneal swelling at up to 240 min

6 %

II

Mean maximum corneal opacity

0.7

II

Mean fluorescein retention

0.0

I

Other Observation

None

 

Applicant's summary and conclusion

Interpretation of results:
other: No prediction can be made. To classify in vivo eye irritation test required.
Remarks:
Criteria used for interpretation of results: OECD GHS
Conclusions:
In this in vitro eye corrosives and severe irritants study, using the Isolated Chicken Eye model with N-(2-HYDROXYETHYL) PHTHALIMIDE (CAS 3891-07-4), no ocular corrosion or severe irritation potential was observed, therefore the results of an in vivo eye irritation study will be necessary for labelling purposes. According to the guideline OECD 438, N-(2-HYDROXYETHYL) PHTHALIMIDE (CAS 3891-07-4) categorized as “No prediction can be made”.