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Diss Factsheets

Administrative data

sub-chronic toxicity: inhalation
Data waiving:
other justification
Justification for data waiving:
Justification for type of information:
Data waiving

Reason: Not most appropriate route of exposure.

Justification: According to Column 2 of REACH Annexes VIII and IX, only the most appropriate route of administration is required, which is based on the likely route of human exposure. Although exposure through the inhalation route is more likely than the oral route, repeat dose oral toxicity data are available on sodium tungstate, which will be used for read across. ECHA’s Guidance R.7a states that although toxicity data obtained using the appropriate route of exposure are preferred, REACH stipulates that animal welfare and scientific considerations are to be taken into account before conducting additional animal tests using a more appropriate route of exposure. In addition, route-to-route extrapolation can be used to assess potential health effects and its threshold in a route other than the one tested. Based on the high solubility, and hence bioavailability, of ammonium metatungstate, data on the oral route of exposure will likely be adequately representative of potential systemic effects from inhalation exposure.

Data source

Materials and methods

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion