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ASSESSMENT OF ACUTE OCULAR IRRITATION / CORROSION

OECD 405

PRINCIPLE OF THE IN VIVO TEST

The substance to be tested is applied in a single dose to one of the eyes of the experimental animal (0.1 mL or 0.1 g); the untreated eye serves as the control. The degree of eye irritation/corrosion is evaluated by scoring lesions of conjunctiva, cornea, and iris, at specific intervals. Other effects in the eye and adverse systemic effects are also described to provide a complete evaluation of the effects. The duration of the study should be sufficient to evaluate the reversibility or irreversibility of the effects.

Animals showing signs of severe distress and/or pain at any stage of the test or lesions should be humanely killed, and the substance assessed accordingly.

GRADING OF OCULAR LESIONS

Cornea
Opacity: degree of density (readings should be taken from most dense area)*
No ulceration or opacity 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre); details of iris clearly visible 1
Easily discernible translucent area; details of iris slightly obscured 2
Nacrous area; no details of iris visible; size of pupil barely discernible 3
Opaque cornea; iris not discernible through the opacity 4

 * The area of corneal opacity should be noted

Iris
Normal 0
Markedly deepened rugae, congestion, swelling, moderate circumcorneal hyperaemia; or injection; iris reactive to light (a sluggish reaction is considered to be an effect 1
Hemorrhage, gross destruction, or no reaction to light 2

Maximum possible: 2

Conjunctivae
Redness (refers to palpebral and bulbar conjunctivae; excluding cornea and iris)
Normal 0
Some blood vessels hyperaemic (injected) 1
Diffuse, crimson colour; individual vessels not easily discernible 2
Diffuse beefy red 3

 

Chemosis
Swelling (refers to lids and/or nictating membranes)
Normal 0
Scattered or diffuse areas of opacity (other than slight dulling of normal lustre);
details of iris clearly visible
1
Obvious swelling, with partial eversion of lids 2
Swelling, with lids about half closed 3
Swelling, with lids more than half closed 4

In accordance with the Regulation EC No. 1272/2008, the test item under investigation could be classified as follows:

The item is to be classified as CATEGORY 1 “Irreversible effects on the eye”.

The corresponding hazard statement is: H318 “Causes serious eye damage” with the signal word: “Danger

If, when applied to the eye, an item produces:

  • at least in one animal, effects on the cornea, iris or conjonctiva that are not expected to reverse or have not fully reversed within an observation period of normally 21 days; and/or
  • Where the test conducted on three animals, if the lesions observed in at least two animals produce one of the following mean values:
    • Ÿ   >= 3 for corneal opacity and/or,
    • Ÿ   > 1.5 for lesions of the iris.

In the two situations mentioned above, all the values obtained at each examination (24, 48 and 72 hours) must be included in the calculation of the respective means.

Ocular lesions are also deemed to be severe if they are still present at the end of the observation period.
Ocular lesions are also considered to be severe if the item or preparation produces an irreversible colouring of the eye.

The item is to be classified as CATEGORY 2 “Irritating to eyes”.

The corresponding hazard statement is: H319 “Causes serious eye irritation” with the signal word: “Warning”

If, when applied to the eye of an animal, an item produces:

  • in at least two of three animals tested animals, a positive responses of:
    • Ÿ   >= 1 for corneal opacity and/or,
    • Ÿ   >=1 for lesions of the iris and/or,
    • Ÿ  >= 2 for redness of the conjunctiva and/or,
    • Ÿ  >= 2 for conjunctival oedema (chemosis).

Price

Turnaround

3 weeks

€ : < 1500 € €€ : between 1500 and 4000 € €€€ : between 4000 and 20000 € €€€€ : > 20000 €
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