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EC number: 404-950-0
CAS number: 21369-64-2
In accordance with Article 17 and 18 REACH
Regulation 1907/2006/EC, a registration for an on-site isolated
intermediate 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 require the performance of such a
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.
N-hexyllithium 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 n-hexyllithium because of its
reactivity and corrosive properties (n-hexyllithium is classified as
corrosive cat. 1A by the registrant). In addition, n-hexyllithium 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).
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.
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