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EC number: 903-919-3 | CAS number: -
INDIVIDUAL AND MEAN SCORES OF CONJUNCTIVAE, IRIS AND CORNEA
TOTAL AND INDIVIDUAL SCORES OF OCULAR IRRITATION
Animal No: A0356
Animal No: A0374
Animal No: A0375
Acute eye irritation was assessed for reaction mass of 2.2’-oxybisbutane (DSBE), DIPE, SBA and 2 -methylpropan-2 -ol (TBA) according to OECD guideline No 405. The test item was instilled as supplied, into the eye of 3 New Zealand rabbits at the dose of 0.1 mL. The experimental protocol was established on the basis of the official method as defined in the OECD guideline No 405 dated April 24th, 2002 and the test method B.5 of the Council regulation No 440/2008. The ocular reactions observed during the study have been moderate to important and totally reversible in the three animals:
- at the conjunctivae level: a moderate redness noted 1 hour after the test item instillation and totally reversible between days 7 and 9, associated with a moderate to important chemosis noted 1 hour after the test item instillation and totally reversible between days 7 and 8,
- at the iris level: a congestion, noted 1 hour after the test item instillation in two animals, and totally reversible on day 1.
- at the corneal level: a moderate corneal opacity, noted 24 hours after the test item instillation, and totally reversible on day 2.
In conclusion, the results obtained, under these experimental conditions, enable to conclude that the test item reaction mass of 2.2’-oxybisbutane (DSBE), DIPE, SBA and 2-methylpropan-2-ol (TBA) has to be classified R36 “irritating to eyes” according to the criteria for the classification, packaging and labelling of dangerous substances in compliance with the E.E.C. Directive n° 67/548, 2001/59 and 99/45. The item is to be characterised by the symbol “Xi” and the warning label “irritant”.
In accordance with the Regulation EC No. 1272/2008 on classification, labelling and packaging of substances and mixtures, the test item has to be classified in category 2 “Irritating to eyes”. The signal word “Warning” and hazard statement H319 “Causes serious eye irritation” are required.
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