Ozone

Repeated dose toxicity: oral

Administrative data

Endpoint:

sub-chronic toxicity: oral

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

a short-term toxicity study by the oral route does not need to be conducted because an appropriate inhalation study is available and inhalation is the most appropriate route of administration as based on the provided thorough and rigorous exposure assessment

a sub-chronic toxicity study (90 days) by the oral route does not need to be conducted because an appropriate inhalation study is available and inhalation is the most appropriate route of administration as based on the provided thorough and rigorous exposure assessment

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
No studies which were performed according to internationally accepted guidelines (OECD Test Guideline 407, 408, and 452) for evaluation of the repeated dose toxicity via the oral 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 standard oral 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 oral exposure is not a primary route of exposure, dosing of the pure substance or high concentrations of the substance to laboratory animals via oral route is omitted in accordance with Annex VIII column 2. This is also in line with the 3R concept.