Ozone

Repeated dose toxicity: dermal

Administrative data

Endpoint:

sub-chronic toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study does not need to be conducted because a reliable sub-chronic (90 days) or chronic toxicity study is available, conducted with an appropriate species, dosage, solvent and route of administration

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
No studies which were performed according to internationally accepted guidelines (OECD Test Guideline 410 and 411) for evaluation of the repeated dose toxicity via the dermal exposition route of pure ozone were found in the public domain or in the archives of the applicants. Likely this is due to the physical nature of ozone. Ozone is a gas and hence standardl and dermal toxicity studies with the pure substance for classification and labelling purposes are technically not feasible. Additionally, ozone is a reactive substance and would therefore react locally at the point of entry and would not be taken up systemically. As dermal exposure is not a primary route of exposure, dosing of the pure substance or high concentrations of the substance to laboratory animals via dermal route is omitted in accordance with Annex VIII column 2. This is also in line with the 3R concept.