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 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
The vapour pressure of the substance was determined to be < 3.2 x 10-3 Pa , which renders inhalation exposure to this substance negligible, negating the need for an acute toxicity study via the inhalation route. This waiver is in accordance with REACH Annex VIII, Section 8.5.2, Column 2 and ECHA Guidance on Information Requirements and Chemical Safety Assessment, Chapter R7.a.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion