Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
Testing on vertebrate animals for the purpose of REACH shall be undertaken only as a last resort.
Considering the physico-chemical properties of the substance exposure of humans via inhalation is not likely. The vapour pressure of the test substance is low (9.0x10E-6 Pa), furthermore the substance is a viscous liquid, therefore generation of aerosols, particles or droplets of inhalable size is not to be expected. Further testing on vertebrate animals for acute toxicity via inhalation route is scientifically not necessary, taken into account available information on intrinsic toxicity. As well exposure of humans via inhalation is not likely, taken into account physico-chemical properties of the substance. In conclusion the occurrence of a systemic toxicity after inhalation relevant to humans is unlikely and therefore the conduct of an acute inhalation toxicity study is not justified.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion