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DL-LACTONE CAS N°:79-50-5 - page 81 / 113

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OECD SIDS 5. TOXICITY

Result:

DL-LACTONE

ID: 79-50-5 DATE: 18.01.2006

Slight oedema (barely perceptible)..............1 Well-defined oedema (edges of area well-defined by definite raising)............................2 Moderate oedema (raised approximately 1 millimeter)...................................3 Severe oedema (raised more than 1 millimeter and extending beyond the area of exposure)......4 (*. Intradermal reactions were assessed for erythema only or, if necrosis is present, the diameter of necrosis.)

Grading Challenge Reactions: No visible change...............................0 Discrete or patchy erythema.....................1 Moderate and confluent erythema.................2 Moderate erythema and swelling..................3 Intense erythema and swelling...................4

Interpretation The results for the experimental animals at the challenge application(s) were compared with the results for the control animals. All skin reactions were considered signs of sensitisation provided that such reactions were less severe or were less persistent in the control group. A sensitisation rate (%) was calculated for each concentration as follows: the number of sensitised animals at one concentration as a proportion of the total number of animals of the experimental group. The results were evaluated according to the OECD Harmonized Integrated Hazard Classification System for Human Health and Environmental Effects of Chemical Substances (OECD, 1998) and the EC criteria for classification and labelling of dangerous substances and preparations (Council Directive 67/548/EEC and all adaptations to technical progress and amendments of this Directive published in the Official Journal of the European Communities).

List of protocol deviations Deviations from the maximum level for relative humidity occurred. Evaluation: Based on laboratory historical data these deviations were considered not to have affected the study integrity. The study integrity was not adversely affected by the deviations. Based on the pretest results, the test substance concentrations selected for the main study were a 5% concentration for the intradermal induction. No signs of irritation were observed up to the highest test substance concentration epidermally tested; therefore, the test site of all animals was treated with 10% SDS approximately 24 hours before the epidermal induction in the main study, to provoke a mild inflammatory reaction; then, a 10% test substance solution mixed 1:1 with Freund's Complete Adjuvant (FCA) was applied under occlusion for epidermal induction. Last, a 50% test substance concentration was selected for the epidermal challenge phase. Main study, Induction The skin effects caused by the intradermal injections exposure during the induction phase are summarised as follows: In the 5% test substance group, 8/10 animals showed grade 1 erythema, 1/10 showed dermal necrosis of 1 mm diameter and the remaining 1/10 showed no effects; all 5 vehicle-only controls showed no

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