Sulfates of potassium, sodium and calcium, byproduct from fermentation

Acute Toxicity: inhalation

Administrative data

Endpoint:

acute toxicity: inhalation

Data waiving:

other justification

Justification for data waiving:

other:

Justification for type of information:

No data are available to evaluate the acute inhalation toxicity. According to column 2 part 8.5.2 of Annex VIII of REACh, the choice for the second route will depend on the nature of the substance and the likely route of human exposure. Testing by the inhalation route is appropriate if exposure of humans via inhalation is likely, taking into account the vapour pressure of the substance and/or the possibility of exposure to aerosols, particles or droplets of an inhalable size”. The test substance at room temperature is a solid made up of single crystalline particles. The melting point is > 400°C and thus, the vapor pressure determination does not need to be conducted (melting point is > 300°C). Based on these data, Sulfates of potassium sodium and calcium, by-product from fermentation is considered to have a low volatility potential. The substance has a Mass Median Aerodynamic Diameter (MMAD) of 378.181 µM with only 10 % of the test material particle size < 144.244 µM. According to Guidance on Information Requirements and Chemical Safety Assessment Chapter R.7a: Endpoint specific guidance (Version 6.0; July 2017), particles larger than 100 μM are less likely to be inhalable. Based on the overall physicochemical data, no exposure by inhalation is expected. Furthermore, the dermal route is the likely route of human exposure. According to the available dermal acute toxicity data, as well as the acute oral toxicity read across data, no toxic effects are expected and no test is required for the acute inhalation toxicity endpoint.