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Toxicological information

Basic toxicokinetics

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Administrative data

Endpoint:
basic toxicokinetics in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
1986
Reliability:
2 (reliable with restrictions)

Data source

Reference
Reference Type:
publication
Title:
Pharmacokinetics of Oral and Intravenous Bromide in Normal Volunteers
Author:
Vaiseman N., Koren G. and Pencharz P.
Year:
1986
Bibliographic source:
Clinical Toxicology, 1986, 24(5), 403-413.

Materials and methods

Objective of study:
toxicokinetics
Test guideline
Qualifier:
no guideline available
Principles of method if other than guideline:
Method: other: Vaiseman (1986)



GLP compliance:
no

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium bromide
EC Number:
231-599-9
EC Name:
Sodium bromide
Cas Number:
7647-15-6
Molecular formula:
NaBr
IUPAC Name:
Active bromine generated from sodium bromide and sodium hypochlorite
Details on test material:
Test substance administered as a solution

Test animals

Species:
human
Strain:
other: N.A.
Sex:
male/female

Administration / exposure

Route of administration:
other: oral and i.v.
Vehicle:
water
Duration and frequency of treatment / exposure:
35 day(s)

Doses / concentrations
Remarks:
Doses / Concentrations:
Males: 1 ml/kg of 3% sodium bromide, equivalent to 30 mg/kg bromide
No. of animals per sex per dose / concentration:
Males: 7

Control animals:
not specified

Results and discussion

Preliminary studies:
no further details

Toxicokinetic / pharmacokinetic studies

Toxicokinetic parameters
Toxicokinetic parameters:
half-life 1st: 9.4 - 11.9 days

Metabolite characterisation studies

Metabolites identified:
no
Details on metabolites:
no further details

Any other information on results incl. tables

Study used 7 healthy young adult volunteers, sex unspecified.

Dose was 1 ml/kg of 3% sodium bromide, equivalent to 30 mg/kg bromide.

Three subjects were studies initially after treatment by the oral route and 4 were first treated intravenously.

Oral bioavailability as area under the curve ranged between 75-118% with a mean of 96 ± 6%.

Elimination T1/2 was 11.9 ± 1.4 days after oral administration and 9.4 ± 1.5 days after i.v. administration.

Bromide is distributed into the extracellular water space.

Bromide is eliminated by the kidney. The clearance rate in this study was 26 ± 1.7 mL/kg/day. This value reflects both the glomerular filtration and tubular reabsorption.

Applicant's summary and conclusion

Conclusions:
Interpretation of results (migrated information): no data
The pharmacokinetics of oral and intravenous bromide was studied in 7 healthy young adult volunteers, who served as their own controls. They received 1mL/kg of 3% sodium bromide, equivalent to 30 mg/kg bromide. Blood samples were taken just prior to administration and periodically during the subsequent 24 hours, and again at 3, 7 and 35 days post administration. Bromide concentrations were then determined by a slowpoke reactor.
Oral bioavailability ranged between 75-118% with a mean of 96 ± 6%.
Elimination T½ was 11.9 ± 1.4 days after oral administration and 9.4 ± 1.5 days after iv administration.
The results of the bromide distribution volume suggest that bromide is distributed into the extracellular water space.
Bromide is eliminated by the kidney. The clearance rate (Cl) in this study was 26 ± 1.7 mL/kg/day. This value reflects both the glomerular filtration and tubular reabsorption.