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ASSESSMENT OF ACUTE DERMAL IRRITATION / CORROSION

OECD 404

PRINCIPLE OF THE TEST

The substance to be tested is applied in a single dose to the skin of an experimental animal (0.5 mL or 0.5 g on approximataely 6 cm²); untreated skin areas of the test animal serve as the control. The degree of irritation/corrosion is read and scored at specified intervals and is further described in order 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 observed.

Animals showing continuing signs of severe distress and/or pain at any stage of the test should be humanely killed, and the substance assessed accordingly. Criteria for making the decision to humanely kill moribund and severely suffering animals are the subject of a separate Guidance Document.

GRADING OF SKIN REACTIONS

Erythema and Eschar Formation

No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beef redness) to eschar formation preventing grading of erythema 4

Oedema Formation

No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of area well defined by definite raising) 2
Moderate oedema (raised approximately 1 mm) 3
Severe oedema (raised more than 1 mm and extending beyond area of exposure) 4

Conclusion

In accordance with the Regulation (EC) No 1272/2008, the item could be classified as follows:

Corrosive item or preparation

An item or preparation is classified as corrosive if, when applied to healthy intact animal skin, it causes tissue destruction in all skin layers, in at least one animal, during skin irritation tests carried or during equivalent method, or if the results can be predicted (e.g. strongly acidic or alkaline items).

The item is to be classified as CATEGORY 1A.

The corresponding hazard statement is: H314 “Causes severe skin burns and eye damage with the signal word: “Danger”

If the item or preparation applied to the health intact skin of an animal causes tissue destruction in all skin layers after an exposure of three minutes or less, or if the result can be predicted.

The item is to be classified as CATEGORY 1B.

The corresponding hazard statement is: H314 “Causes severe skin burns and eye damage with the signal word: “Danger”

If the item or preparation applied to the health intact skin of an animal causes tissue destruction in all skin layers after an exposure not exceeding one hour, or if the result can be predicted.

The item is to be classified as CATEGORY 1C.

The corresponding hazard statement is: H314 “Causes severe skin burns and eye damage with the signal word: “Danger”

If the item or preparation applied to the health intact skin of an animal causes tissue destruction in all skin layers after an exposure not exceeding four hours, or if the result can be predicted.

If the items are organic hydrogen peroxides, except where proven to be safe.

  • Irritant item or preparation

The item is to be classified as CATEGORY 2.

The corresponding hazard statement is: H315 “Causes skin irritation” with the signal word: “Warning”

Items and preparations causing significant inflammation of the skin, persisting at least 24 hours after a period of exposure not exceeding four hours during a test on rabbits conducted in accordance with the cutaneous irritation test method.

  1. Mean value of ≥ 2.3 – ≤ 4.0 for erythema/eschar or for oedema in at least 2 of 3 tested animals from gradings at 24, 48 and 72 hours after patch removal or, if reactions are delayed, from grades on 3 consecutive days after the onset of skin reactions; or
  2. Inflammation that persists to the end of the observation period normally 14 days in at least 2 animals, particularly taking into account alopecia (limited area), hyperkeratosis, hyperplasia, and scaling; or
  3. In some cases where there is pronounced variability of response among animals, with very definite positive effects related to chemical exposure, in a single animal but less than the criteria above.

Price

Turnaround

2 weeks

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