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| TSAR : Tracking System for Alternative test methods Review, Validation and Approval in the Context of EU Regulations on Chemicals |
| Acute Systemic Toxicity |
| B.1 bis Acute oral Toxicity - Fixed Dose Procedure (FDP) |
| 3 Rs Category | : | Reduction and refinement |
| Type of Method | : | In vivo |
| Validation Statement | : | 31/10/2007.
ESAC retrospective statements were issued due to formal needs under the Cosmetics Directive. |
| Comment | : | Replaces the old B.1 method on acute oral toxicity (the LD50 method) which was DELETED in Dir 2001/59/EC (Official Journal L 225 2001). |
| Status of adoption in EU | : | Adopted in 1992. |
| 1st Published in EC Regulations/ Updates | : | Directive 92/69/EC (Official Journal L 383A 1992)/Directive 2004/73/EC (Official Journal L 152 2004) |
| Reconducted to TMR (updated when appropriate) | : | Regulation 440/2008/EC (Official Journal L 142 2008) |
| Text of EU method | : | B.1 bis |
| Corresponding OECD TG | : | TG 420 |
| Status of adoption by OECD | : | OECD |
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