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EC number: 202-935-1 | CAS number: 101-34-8
Key studies were performed according to internationally recognised testing guidelines prior to the adoption of the OECD Principles of GLP in 1992.
In this guideline equivalent study ( EPA OPP 81 -5) and prior to the adoption of OECD principles of GLP, the test material (EC 205-363-0) induced a primary dermal irritation score of 1.48. The study was conducted in 6 New Zealand White rabbits across the 24, 48, & 72 hour observation periods. The test material was exposed to the test animals (intact skin and abbraded skin, 24 hours) under occlusive conditions. The result of the test is not sufficient to meet the criteria for classification as a skin irritant under the criteria of the EU Classification, Labelling, and Packaging (CLP) regulation (1272/2008).
In this guideline equivalent study (EPA OPP 81 -4), conducted prior to the adoption of the OECD principles of GLP in 1992, the test material (EC 205-363-0) was not considered an ocular irritant to the rabbit. Six New Zealand White rabbits were treated with 0.1ml of the unchanged substance in one eye, the contralateral eye served as a control. Rabbits were observed for corneal opacity, iritis, and conjunctivitis at 24, 48, and 72 hours after treatment, and again 4 day and 7 days after treatment. Results were scored accoring to the Draize criteria. The test material induced a mean overal irritation score of 0.3 at 24 hours, this was fully reversible at the 48 hour observation.
The registered substance failed to induce sufficient skin or eye irritation to meet the criteria for classification as a skin or eye irritant in accordance with the Classification, Labelling, and Packaging (CLP) regulation (1272/2008).
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