Registration Dossier

Administrative data

two-generation reproductive toxicity
Data waiving:
study scientifically not necessary / other information available
Justification for data waiving:
the study does not need to be conducted because (i) the substance is of low toxicological activity (no evidence of toxicity seen in any of the tests available), (ii) it can be proven from toxicokinetic data that no systemic absorption occurs via relevant routes of exposure (e.g. plasma/blood concentrations below detection limit using a sensitive method and absence of the substance and of metabolites of the substance in urine, bile or exhaled air) and (iii) there is no or no significant human exposure
Justification for type of information:
In accordance with column 2 of Annex VIII (required in Section 8.7.1) and Annexes IX and X (required in Section 8.7) of REACH Regulation 1907/2006: no additional study should be conducted, based on the high tolerance and the natural abundance of SiO2 and silicates as mineral, along with developmental toxicity data.

Data source

Materials and methods

Results and discussion

Applicant's summary and conclusion