Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
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
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
The physical state of test item was solid. The test item was milled with the help of air jet milling machine but it chocked up the milling machine (test item converted into the lumps and become solid). Hence, milling of test item was not possible through air jet milling.
Test item was tried to grind with mixer grinder and powder was formed. So, pre-test was conducted without rats for generation of dust using dust generator (Rotating Brush Generator), 70 psi air pressure, brush speed at 600 Rotation per Minute (RPM) and feeding rate set at 20 mm/h. The test item started
to melt, therefore generation of dust was not possible from the test item.
Afterward solubility test was performed with RO water, dimethyl sulphoxide (DMSO) and polyethylene glycol 400. The test item found insoluble in all above listed solvent/vehicle.
Due to above mentioned nature of test item, it is not possible to conduct inhalation study.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion