Registration Dossier

Toxicological information

Acute Toxicity: oral

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Administrative data

Endpoint:
acute toxicity: oral
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
Justification for type of information:
In accordance with Article 17 and 18 REACH Regulation 1907/2006/EC, a registration for an on-site isolated intermediate manufactured and handled under strictly controlled conditions or a transported isolated intermediate handled under strictly controlled conditions in quantities of lower than 1000 tonnes per year per manufacturer or importer does not need to perform such a study. In addition, in accordance with column 2 of REACH Regulation 1907/2006/EC Annex VII section 8.5. even for substances not fulfilling the criteria of intermediates handled under strictly controlled conditions a study on this endpoint does not need to be conducted if the substance is classified corrosive to the skin. Lithium diisopropylamide is a corrosive and pyrophoric intermediate, manufactured and handled under strictly controlled conditions (lower 1000 t/a). Studies to determine the acute systemic toxicity cannot be performed with lithium diisopropylamide because of its reactivity and corrosive properties (lithium diisopropylamide is classified as corrosive cat.1B by the registrant). In addition, lithium diisopropylamide is pyrophoric and would react violently (exothermic) on exposure with animal tissues (due to the water content), releasing corrosive lithium hydroxide and likely starting to burn. Therefore the oral toxicity study has also to be waived for animal welfare reasons. Further, according to an expert statement (iTEConsult. 2011-12-08) there is no need for further classification (read across) for lithium organyles with the same classification as for lithium according to Regulation (EC) No 1272/2008 when they are used undiluted and / or exposure can be excluded due to the applied risk management measures that are stipulated e.g. for a corrosive, pyrophoric intermediate that is handled under strictly controlled conditions. Thus, for regulatory purposes (registration, C&L) the performance of the oral toxicity study is neither required (intermediate < 1000 t/a, exposure) nor technical feasible or in line with animal welfare (corrosive, pyrophoric properties).

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