Registration Dossier

Administrative data

Endpoint:
basic toxicokinetics
Type of information:
other: Expert review and assessment
Adequacy of study:
key study
Reliability:
other: Not assignable as result is from expert assessment.

Data source

Materials and methods

Objective of study:
other: Assessment of toxicokinetic behaviour
Test guideline
Qualifier:
according to
Guideline:
other: Assessment of toxicokinetic behaviour of the substance derived from available data as required by REACH Annex VIII section 8.8

Results and discussion

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): other: Based on expert assessment the test substance will be absorbed, but will not bioaccumulate.
Executive summary:

INTRODUCTION

An expert assessment of the toxicokinetic behaviour of the test substance was undertaken using data derived from an Annex VIII testing regime.

CONCLUSION

An assessment of the potential absorption of the test substance based on its physico-chemical properties suggest that absorption across thegastrointestinal mucosa is likely to be slow and part of an oral dose will be excreted in the faeces. However, a proportion of the substance will be systemically absorbed following oral administration. This is supported by the observation of histopathological changes in a number of tissues observed in the 28-day study.  

 

The test substance is likely to be subject to metabolism via sulphonic acid groups on its structure and these will also aid excretion via the kidneys.  Due to discoloration of the urine observed in the 28-day study, it can be concluded that the test substance and/or its metabolites are subsequently excreted, at least in part, via the kidneys.

 

Although the test substance is systemically absorbed, there is no expectation that it will preferentially distribute to particular organs or tissues in the body.