Registration Dossier
Registration Dossier
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EC number: 215-183-4 | CAS number: 1310-65-2
Repeated dose toxicity: inhalation
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
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.
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