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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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

Toxicological information

Health surveillance data

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Administrative data

Endpoint:
health surveillance data
Type of information:
experimental study
Adequacy of study:
supporting study
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
other: Acceptable, well documented publication which meets basic scientific principles.

Data source

Reference
Reference Type:
publication
Title:
Unnamed
Year:
2006

Materials and methods

Study type:
medical monitoring
Endpoint addressed:
basic toxicokinetics
Principles of method if other than guideline:
Randomized, open-label, parallel-group, phase I study conducted to investigate absolute bioavailability and excretory routes for systemic lanthanum in healthy subjects.
GLP compliance:
not specified

Test material

Constituent 1
Details on test material:
- Name of test material (as cited in study report): Lanzhanum chloride
- Analytical purity: no data

Method

Type of population:
general
Ethical approval:
confirmed, but no further information available
Remarks:
The final protocol and subject-informed consent documentation were approved by the Ravenscourt Ethics Committee (UK) prior to the start of the study
Details on study design:
Refer to any other information on materials and methods.

Results and discussion

Results:
Lanthanum chloride infusion was well tolerated. The mean ± SD plasma concentration of lanthanum increased from a baseline of < 0.05 ng/mL to a maximum of 5.1 ± 0.9 ng/mL at 3.3 ± 0.8 hours after the start of the infusion. Plasma lanthanum concentrations subsequently declined triphasically, with a mean ± SD terminal elimination half-life of 37 ± 22 hours (range 15-77 hours). Lanthanum plasma exposure (mean ± SD, AUC) after intravenous dosing was 38.9 ± 10.5 ng h/mL. The total clearance of lanthanum (55 ± 16 mL/min) was low relative to average hepatic blood flow (1470 mL/min). Lanthanum was widely distributed after infusion, with an apparent volume of distribution of 164 ± 84 L. Intravenous administration confirmed low renal clearance (0.95 ± 0.60 mL/min), just 1.7% of total plasma clearance. Fecal lanthanum excretion was not quantifiable after intravenous administration owing to high and variable background fecal lanthanum and constraints on the size of the intravenous dose.

Applicant's summary and conclusion