fermentation residues of molasses, yeast extract, sucrose and ammonia with bacillus subtilis

Endpoint summary

Additional information

Generally, in the absence of reliable toxico-kinic study data, a toxicokinetic assessment is based on the physico-chemical properties of the substance. Based on those properties, together with information from toxicity tests, an indication for absorption by the oral, dermal and inhalation route is given.

Physical chemical properties need to be determined on the substance as such (dry matter). In contrast, Biomass Residue obtained after B2 production, will be brought on the market in liquid form (as aquous suspension) only. It is anticipated that exposure to Biomass Residue obtained after B2 production as a solid can be excluded, and therefore Biomass Residue obtained after B2 production as a solid will not be considered here. For risk assessment purposes Biomass Residue obtained after B2 production is only to be considered as a liquid. In line with this, (eco-) toxicological testing has been performed with the liquid form of biomass residue obtained after B2 production.

As the physico-chemical properties of Biomass Residue obtained after B2 production are restricted to the solid phase of the substance, and data for the liquid substance are lacking, no reliable information on the liquid substance is available for a toxicokinetic risk assessment. In the absence of reliable information on toxicokinetic behaviour of Biomass Residue obtained after B2 production, in accordance with ECHA Guidance on information requirements and chemical safety assessment, Chapter R.8 [4], for risk assessment purposes the following default values are considered appropriate: 50% for oral absorption, in the absence of substance specific data, 50% for dermal absorption, as this will not be higher than oral absorption, and 100% for inhalation absorption.