Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because the substance is classified as corrosive to the skin
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:
JUSTIFICATION FOR DATA WAIVING
An OECD 431 (EPIDERM) corrosion study was performed on the test item, and the result determined that the test item is corrosive (combination of Cat. 1B and 1C). As per Regulation (EC) 1907/2006, Annex VIII, Part 8.5, Column 2:
The study/ies do(es) not generally need to be conducted if: the substance is classified as corrosive to the skin.
In addition to the above, there is no indication that there is any acute toxicity at concentrations below the corrosivity levels.
Furthermore, as per Regulation (EC) 1907/2006, Part 8.5.2., Column 2:
Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely taking into account the possibility of exposure to aerosols, particles or droplets of an inhalable size.
The registrant confirms that the test item is formulated into a non-granular form prior to import and being placed on the market, therefore there is no liklihood of human exposure to particles of an inhalable size.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion