Concentrates of lead and zinc compounds with sulfur resulting from hydrometallurgy (hot acid leaching, super-hot acid leaching and flotation)

Repeated dose toxicity: dermal

Administrative data

Endpoint:

short-term repeated dose toxicity: dermal

Data waiving:

exposure considerations

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:

JUSTIFICATION FOR DATA WAIVING
Based on Annex XI of REACH, no study was conducted since dermal route is not relevant route of human exposure. According to the chemical composition analysis the product consists primarily of sulphur (ca. 35 %), lead (ca. 25 %) and zinc (ca. 17 %). According to transformation/dissolution study (OECD guidance 29) conducted for the substance, the most critical constituents leachable to water from this UVCB substance are lead and zinc compounds. Therefore, the chemical safety assessment focuses on the evaluation of the read-across data from Pb and Zn compounds.Dermal absorption of lead and zinc compounds through intact skin is expected < 0.1% and < 2%, respectively. Thus absorption through skin is not significant and the dermal route is not relevant route of human exposure. Also available dermal toxicity studies on inorganic lead and zinc compounds indicate a very low acute dermal toxicity (LD50 > 2000 mg/kg bw/day).