Registration Dossier

Diss Factsheets

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

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%

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