Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: A theoretical summary of the toxicokinetics is provided in the attachments.
Adequacy of study:
weight of evidence
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: The argument covers on the theoretical details, and is not an experimental study.

Data source

Reference
Reference Type:
other: An argument written internally
Title:
Unnamed
Year:
2012

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
No guideline has been followed, as this is a theoretical argument.
GLP compliance:
not specified
Remarks:
Not relevant - data is a theoretical argument

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Not relevant for a theoretical argument
Radiolabelling:
not specified
Remarks:
Not relevant for a theoretical argument

Administration / exposure

Route of administration:
other: Not relevant for a theoretical argument
Vehicle:
other: Not relevant for a theoretical argument
Details on exposure:
Not relevant for a theoretical argument
Duration and frequency of treatment / exposure:
Not relevant for a theoretical argument
Doses / concentrations
Remarks:
Doses / Concentrations:
Not relevant for a theoretical argument
No. of animals per sex per dose / concentration:
Not relevant for a theoretical argument
Control animals:
other: Not relevant for a theoretical argument
Positive control reference chemical:
Not relevant for a theoretical argument
Details on study design:
Not relevant for a theoretical argument
Details on dosing and sampling:
Not relevant for a theoretical argument
Statistics:
Not relevant for a theoretical argument

Results and discussion

Preliminary studies:
Not relevant for a theoretical argument

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Not relevant for a theoretical argument
Details on distribution in tissues:
Not relevant for a theoretical argument
Details on excretion:
Not relevant for a theoretical argument

Metabolite characterisation studies

Details on metabolites:
Not relevant for a theoretical argument

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
N-(n-octyl)-2-pyrrolidinone will only slightly bioaccumulate.
Executive summary:

A theoretical argument is provided, and this shows that bioaccumulation should be low.