Registration Dossier

Administrative data

Endpoint:
acute toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
The rules for adaptation in Column 2 of the REACH Annex VIII state that, “in addition to the oral route (8.5.1), for substances other than gases, the information mentioned under 8.5.2 to 8.5.3 [inhalation and dermal acute toxicity] shall be provided for at least one other route. The choice for the second route will depend on the nature of the substance and the likely route of human exposure. If there is only one route of exposure, information for only that route need be provided”. The rules for adaptation also state that, “Testing by the dermal route is appropriate if…inhalation of the substance is unlikely…”. As oral and dermal routes of exposure are more relevant, testing for acute inhalation toxicity is therefore waived based on this information.Furthermore on the basis of the OECD n° 110 test the majority of the particle size (92.3%) was between 45 and 125 µm. Therefore there is no alveolar fraction and systemic effect after inhalation is not expected.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion