Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics, other
Remarks:
evaluation of existing test and data
Type of information:
other: statement
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
study well documented, meets generally accepted scientific principles, acceptable for assessment

Data source

Reference
Title:
Unnamed
Year:
2018

Materials and methods

Objective of study:
absorption
distribution
excretion
metabolism
toxicokinetics
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Expert judgement with evaluation of toxicokinetic, metabolism and excretion.
GLP compliance:
not specified

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Radiolabelling:
no

Results and discussion

Metabolite characterisation studies

Metabolites identified:
yes

Applicant's summary and conclusion

Conclusions:
Not bioaccumulative
Executive summary:

Based on the data available, the substance undergoes to a metabolic degradation into metabolites which are excreted by urine and faeces and therefore the substance can be considered as not-bioaccumulative.