Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Expert assessment
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Estimation based on testing performed on this class of substance.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2010
Report Date:
2010

Materials and methods

Objective of study:
other: ADME assessment
Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
Assessment based on data presented in registration dossier. No further animal testing is justified
GLP compliance:
no

Test material

Reference
Name:
Unnamed
Type:
Constituent
Radiolabelling:
no

Results and discussion

Main ADME resultsopen allclose all
Type:
absorption
Type:
distribution
Type:
metabolism
Type:
excretion

Toxicokinetic / pharmacokinetic studies

Details on absorption:
Absorption by oral route as transient systemic effects seen in test animals
Details on distribution in tissues:
Effects indicate exposure to liver and kidneys
Details on excretion:
No firm evidence, but kidney response seen in highest treatment group

Metabolite characterisation studies

Metabolites identified:
no

Any other information on results incl. tables

Substance is known to be readily biodegradable, suggesting that metabolism to CO2 will occur in biological systems

Applicant's summary and conclusion

Conclusions:
There appears to be limited risk of bioaccumulation