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

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics

Type of information:

other: assessment based on available info

Adequacy of study:

key study

Study period:

April 2011

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

other: non-GLP assessment report

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2011

Materials and methods

Test guideline

Qualifier:

no guideline required

Principles of method if other than guideline:

assessment of all available data

GLP compliance:

no

Test material

Test material information

Constituent 1

Reference substance name:

Biomass residue (liquid) obtained after B2 production

IUPAC Name:

Biomass residue (liquid) obtained after B2 production

Test animals

Species:

other: none

Strain:

other: none

Administration / exposure

Route of administration:

other: oral, dermal, inhalation

Vehicle:

unchanged (no vehicle)

Results and discussion

Main ADME results

Type:

absorption

Results:

For risk assessment purposes, the oral, dermal, inhalation absorption is set at 100%

Any other information on results incl. tables

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, for risk assessment purposes

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.

Applicant's summary and conclusion

Conclusions:

Interpretation of results (migrated information): other: For risk assessment purposes, the oral, dermal, inhalation absorption is set at 100%