Barium

Repeated dose toxicity: dermal

Administrative data

Endpoint:

sub-chronic toxicity: dermal

Data waiving:

other justification

Justification for data waiving:

a short-term toxicity study does not need to be conducted because exposure of humans via the dermal route in production and/or use is not likely as based on the provided thorough and rigorous exposure assessment

Justification for type of information:

According to the data requirements as outlined in Annexes VIII-IX, 8.6 of Regulation (EC) 1907/2006, Column 2, a repeated dose toxicity study shall be via the most appropriate route of administration, having regard to the likely route of human exposure. The oral route is considered the most appropriate route of exposure, for which repeated dose toxicity studies are available. Further, toxic effects of barium substances after repeated exposure via the dermal route are not considered to be of any relevance or concern. Since the dermal absorption of barium dichloride is assumed to be low to negligible, percutaneous transfer is not considered to represent a relevant route of entry into the body. In consequence, a study in experimental animals on toxicity via repeated dermal exposure is not considered to be required. In accordance with ECHA guidance on information requirements and chemical safety assessment-chapter R.8: characterisation of dose [concentration]-response for human health, November 2012, a DNEL for systemic effects via skin exposure may be derived by route-to-route extrapolation from a 90-day oral toxicity study in rats with barium dichloride dihydrate (Dietz et al, 1992).

Results and discussion

Target system / organ toxicity

Critical effects observed:

not specified