Registration Dossier

Administrative data

Endpoint:
sub-chronic toxicity: dermal
Data waiving:
other justification
Justification for data waiving:
other:
Justification for type of information:
JUSTIFICATION FOR DATA WAIVING
According to Annex 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 dermal route is possible, repeat dose oral toxicity data are available on sodium tungstate. 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 sodium tungstate, data on the oral route of exposure will likely be adequately representative of potential systemic effects from dermal exposure.

Data source

Materials and methods

Test material

Constituent 1
Chemical structure
Reference substance name:
Disodium wolframate
EC Number:
236-743-4
EC Name:
Disodium wolframate
Cas Number:
13472-45-2
Molecular formula:
Na2WO4
IUPAC Name:
disodium dioxotungstenbis(olate)

Results and discussion

Target system / organ toxicity

Critical effects observed:
not specified

Applicant's summary and conclusion