Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.

The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.

Diss Factsheets

Administrative data

Endpoint:
basic toxicokinetics in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Non GLP/OECD study but can be considered as reliable data

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2011

Materials and methods

Test guideline
Qualifier:
no guideline followed
Principles of method if other than guideline:
in vitro rat hepatocyte metabolism study using LCMS analysis
GLP compliance:
no

Test material

Radiolabelling:
no

Test animals

Species:
other: in vitro rat hepatocytes

Administration / exposure

Route of administration:
other: in vitro plate administration
Vehicle:
unchanged (no vehicle)
Duration and frequency of treatment / exposure:
4 hours
Doses / concentrations
Remarks:
Doses / Concentrations:
10, 500, 100uM
No. of animals per sex per dose / concentration:
NA

Results and discussion

Metabolite characterisation studies

Metabolites identified:
yes
Details on metabolites:
Florhydral is oxidised readily to from the corresponding acid which is then readily glucuronidated. Hydroxylation may also occur, again followed by glucuronidation

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): low bioaccumulation potential based on study results
Florhydral is readily metabolised in vitro in rat hepatocytes via oxidation and subsequent glucuronidation. In vivo metabolism is expected to follow a similar pathway with efficient metabolism and excretion at the low doses that workers and consumers will be exposed to.