Potassium benzoate

Basic toxicokinetics

Administrative data

Endpoint:

basic toxicokinetics, other

Remarks:

Review of human data

Type of information:

other: Literature review

Adequacy of study:

key study

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Potassium and sodium benzoate salts are used extensively in drug and food applications and there has been a lot of research into human toxicity.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Objective of study:

absorption

distribution

excretion

metabolism

Test guideline

Qualifier:

no guideline followed

Version / remarks:

Literature review

Principles of method if other than guideline:

A review of literature from a number of national and international reviews relating to use of potassium and benzoates salts in food and pharmaceuticals has been made to assess potential toxicity of potassium benzoate. In view of the wealth of data on these ions, and in view of the necessity to avoid new animal testing, it is considered justified to perform this review

Test material

Test material information

Constituent 1

Reference substance name:

Potassium benzoate

EC Number:

209-481-3

EC Name:

Potassium benzoate

Cas Number:

582-25-2

Molecular formula:

C7H6O2.K

IUPAC Name:

potassium benzoate

Specific details on test material used for the study:

Literature review includes examination of food additive sodium benzoate

Test animals

Species:

other: Human

Administration / exposure

Route of administration:

oral: unspecified

Duration and frequency of treatment / exposure:

Chronic / Long-term

Results and discussion

Main ADME results

Main ADME results 1

Type:

absorption

Results:

Rapid oral absorption

Main ADME results 2

Type:

distribution

Results:

Readily distributed as dissociated ions

Main ADME results 3

Type:

metabolism

Results:

Benzoate rapidly metabolised

Main ADME results 4

Type:

excretion

Results:

Excess potassium can be excreted in urine and sweat. Benzoate is metabolised and not excreted.

Toxicokinetic / pharmacokinetic studies

Details on absorption:

Potassium and Benzoate ions rapidly absorb orally.

Dermal penetration of potassium salts and benzoates has not been well evaluated, but in view of the relatively low molecular weight and solubility in water, it is likely that there is some dermal penetration.

Potassium undergoes ion exchange with sodium and for this reason is thought to adsorb into the skin and not necessarily penetrate. This ion-exchange is two-way and loss through sweat from skin could reverse and local absorption.

Details on distribution in tissues:

Potassium and benzoate are distributed widely throughout the body.

Transfer into organs

Key result

Test no.:

#1

Transfer type:

blood/brain barrier

Remarks:

Potassium

Observation:

distinct transfer

Details on excretion:

Benzoates are not excreted, but are instead metabolised and metabolites will ultimately include carbon dioxide and water. There is evidence of carbon from benzoates being found in other organic substances formed by the body.

Excess potassium is excreted in sweat and urine. The kidney has been found to accumulate Potassium during periods of dehydration.

Metabolite characterisation studies

Details on metabolites:

Benzoate ions are readily metabolised and metabolic pathways have been described in public literature

Applicant's summary and conclusion

Conclusions:

Benzoate ions are readily metabolised and metabolic pathways have been described in public literature