Registration Dossier

Diss Factsheets

Administrative data

Endpoint:
sub-chronic toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Additional testing by inhalation route is not applicable 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 hydroxide and its monohydrate is negligible based on the melting point of 423 °C (see IUCLID section 4.2). By testing on particle size distribution (granulometry) inhalable particles lower 10 µm were detected in some qualities (see IUCLID section 4.5.1). If relevant, respective personal protective measurements are applied (as addressed in the CSR). Toxicity after repeated inhalation exposure was scientifically sound 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

Categories Display