Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

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:
test procedure in accordance with generally accepted scientific standards and described in sufficient detail

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012

Materials and methods

Principles of method if other than guideline:
The ocular irritancy potential of the test item was assessed using the Rabbit Enucleated Eye Test. The method used is based on that described by Draize, Woodward and Calvery (1944) (Draize J.H, Woodward G and Calvery H (1944) Methods for the study of irritation and toxicity of substances applied topically to the skin and mucous membranes. J Pharmacol 0 Exptl. Therap. 82, 377-390).
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
- Name of test material (as cited in study report): Copper iodide
- Analytical purity: 99.7%
- Lot/batch No.: 108701/2 REACH STANDARD 290911
- Storage condition of test material: room temperature in the dark

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
Source: Enucleated eyes were obtained from the New Zealand White strain of rabbit.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent negative control
Amount / concentration applied:
Amount applied: 0.1 ml of the test item, which was found to weigh approximately 96 mg.
Duration of post- treatment incubation (in vitro):
Observation period: 240 minutes
Number of animals or in vitro replicates:
Five enucleated eyes were used (three for the main test, and a further two for control purposes).
Details on study design:
The enucleated eyes were maintained at a temperature of 32°C ± 1.5°C within the superfusion apparatus. The test item was applied onto the cornea of each of three enucleated eyes. The direct effect of the test item on the cornea was assessed by evaluation of corneal thickness, corneal opacity, alteration of corneal epithelium and fluorescein uptake, throughout the duration of the test. The data for all endpoints was assessed and an estimate of ocular irritancy potential made. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9% Sodium Chloride).

The McDonald-Shadduck score system was used to evaluate ocular irritation.

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Run / experiment:
Replicates 1, 2, and 3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
other: corneal epithelium condition
Run / experiment:
Replicates 1, 2 and 3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
fluorescein retention score
Run / experiment:
Replicates 1, 2 and 3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Positive controls validity:
not applicable
Remarks on result:
no indication of irritation
Irritation parameter:
percent corneal swelling
Run / experiment:
Mean of 3 eyes (60 mins post dosing)
Value:
15.3
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Remarks:
7.6% corneal swelling (mean of 2 eyes, 60 mins post dosing)
Positive controls validity:
not applicable
Irritation parameter:
percent corneal swelling
Run / experiment:
Mean of 3 eyes (120 mins post dosing)
Value:
17
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Remarks:
5.5% corneal swelling (mean of 2 eyes, 120 mins post dosing)
Positive controls validity:
not applicable
Irritation parameter:
percent corneal swelling
Run / experiment:
Mean of 3 eyes (240 mins post dosing)
Value:
15.9
Vehicle controls validity:
not applicable
Negative controls validity:
valid
Remarks:
1.8% corneal swelling (mean of 2 eyes, 240 mins post dosing)
Positive controls validity:
not applicable

Any other information on results incl. tables

See Table 4 (attached) for the results of the initial Rabbit Enucleated Eye Test. These indicated that the test item was unlikely to cause severe ocular irritancy.

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
The test item was considered unlikely to have the potential to cause severe ocular irritancy in vivo.
Executive summary:

The ocular irritancy potential of copper (I) iodide was assessed using the Rabbit Enucleated Eye Test.  The method used is based on that described by Draize, Woodward and Calvery (1944).  Five enucleated eyes, obtained from the New Zealand White strain of rabbit, were maintained at a temperature of 32°C ± 1.5°C within the superfusion apparatus.  0.1 ml of the test item, which was found to weigh approximately 96 mg, was applied onto the cornea of each of three enucleated eyes.  The direct effect of the test item on the cornea was assessed by evaluation of corneal thickness, corneal opacity, alteration of corneal epithelium and fluorescein uptake, throughout the duration of the test.  The data for all endpoints was assessed and an estimate of ocular irritancy potential made. A further two enucleated eyes were treated, for control purposes, with saline solution (0.9% Sodium Chloride). Following assessment of the data for all endpoints, the test item was considered unlikely to have the potential to cause severe ocular irritancy in vivo.