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Administrative data

short-term repeated dose toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
Justification for type of information:
Additional testing by the inhalation route is not required as data on repeated dose oral / systemic toxicity was provided. According to the REACH Regulation No. 1907/2006, Annex VIII, 8.6.1 only one repeated dose toxicity study is required with administration via the most appropriate route. Moreover, the vapour pressure of lithium is negligible (see IUCLID section 4.2). Toxicity after repeated inhalation exposure was extrapolated from systemic doses from studies with repeated oral administration according to the guidance document.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion