Registration Dossier

Diss Factsheets

Administrative data

acute toxicity: inhalation
Data waiving:
study technically not feasible
Justification for data waiving:
the study does not need to be conducted because exposure of humans via inhalation is not likely taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size
Justification for type of information:
REACH Annex XI (2) Testing is technically not possible:
- For an acute inhalation toxicity test , particle size distribution around 4µm is needed. Such a sample is not technically feasible to be prepared since In is a soft metal. Instead of trying to make smaller particle size <<20µm the material will stick together and result in bigger particles again.
- Indium powder ≤20µm is not marketed as such for industrial scale
- In is a soft metal and probably no exposure is possible because of no dust exposure, therefore: No inhalation exposure to indium metal at the workplace (REACH Annex XI(3) exposure considerations). This is supported by a dustiness test on dust fractions of 1g indium powder (20µm). It can be concluded from this dustiness test that: the tested sample is worst case and not marketed as such and showing very small dustiness values for the alveolar fraction. Therefore, it can be concluded that for industrial In metal shots no dust exposure is occurring, so there is no inhalation exposure to indium metal (reference: Final - Report on the determination of the dust generation tendency (“dustiness”) of Indium - Report No. GS 3 – 00 043 13, DMT GmbH & Co. KG)

Data source

Materials and methods

Results and discussion

Clinical signs:

Applicant's summary and conclusion