Zinc glycinate sulfate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Data waiving:

study scientifically not necessary / other information available

Justification for data waiving:

the study does not need to be conducted because the physicochemical and toxicological properties suggest no potential for a significant rate of absorption through the skin

the study does not need to be conducted because the substance does not meet the criteria for classification as acute toxicity or STOT SE by the oral route and no systemic effects have been observed in in vivo studies with dermal exposure (e.g. skin irritation, skin sensitisation)

Justification for type of information:

JUSTIFICATION FOR DATA WAIVING
The dermal route is not expected to considerably contribute to zinc absorption in healthy skin (Niagru, 2007). Relevant absorption may occur only in damaged skin, but data are limited (ATSDR, 2005). The EU RAR (2008) cites a study in which the authors concluded that dermal penetration of zinc was below 1% based on the cumulative amount recovered from the receptor fluid at 72 hours. The default for dermal absorption of solutions or suspensions of zinc or zinc compounds was chosen to be 2% in the EU RAR (2008). In the review paper by Franken et al. (2015), the in vitro permeation of metals through human skin was assessed and the authors concluded that zinc cannot permeate through intact human skin under physiological conditions. Therefore, dermal absorption is not expected to be a relevant route of exposure of zinc monoglycinate sulfate.