Registration Dossier

Administrative data

Link to relevant study record(s)

Reference
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.
Objective of study:
other: ADME assessment
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
Radiolabelling:
no
Type:
absorption
Type:
distribution
Type:
metabolism
Type:
excretion
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
Metabolites identified:
no

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

Conclusions:
There appears to be limited risk of bioaccumulation

Description of key information

Short description of key information on bioaccumulation potential result:

The substance appears to be absorbed through ingestion with some blood chemistry and transient histopathological changes seen as a result of exposure to liver and kidneys following repeated oral dose.  Evidence therefore of absorption, distribution, metabolism and possible excretion.

Key value for chemical safety assessment

Bioaccumulation potential:
no bioaccumulation potential

Additional information

Effects seen in the repeat dose oral study suggests that this class of substance will be absorbed following ingestion and will be metabolised. The biodegradation study indicates that metabolism is possible in cells and the results of blood chemistry changes and minor adaptive changes in the kidney suggest that excretion processes are working.