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8.9.3. Long-term repeated dose toxicity (≥ 12 months) The long-term toxicity study (≥ 12 months) does not need to be conducted if: Long-term exposure can be excluded and no effects have been seen at the limit dose in the 90-day study or a combined long-term repeated dose/carcinogenicity study (8.11.1) is undertaken
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Source: EUR-Lex (Cellar) · retrieved 2026-10-29 · Text as adopted (Official Journal); later amendments are not incorporated in this text.