Potassium benzoate

Acute Toxicity: oral

Administrative data

Endpoint:

acute toxicity: oral

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

weight of evidence

Study period:

Review document

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

As with all salts, the significance for toxicity assessment is the presence of specific ions that will form when in solution or when in biological systems. In the case of metal salts of organic acids, the cation is generally critical to determine the solubility and bioavailability if the key physico-chemical properties are equivalent, the potential for absorption if ingested and hazard will be equivalent; this is especially so for potassium and sodium salts that share similar solubility and dissociation characteristics.The cation is only critical in determining hazard if this is itself hazardous, but if the metal cations are present in the diet or are ‘essential’ elements for health, then there should be little to differentiated long-term hazards. Potassium is essential in the diet, Read-across to sodium salts and the benzoic acid is therefore considered valid.

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

no guideline followed

Principles of method if other than guideline:

A review of literature from a number of national and international reviews relating to use of lithium 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.

GLP compliance:

no

Test type:

other: Various methods used to assess toxicity of potassium and benzoate salts

Limit test:

no

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

Test animals

Species:

rat

Strain:

not specified

Sex:

male/female

Administration / exposure

Route of administration:

oral: unspecified

Vehicle:

not specified

Details on oral exposure:

The review is based on a number of oral toxicity studies, predominantly using rats.Different methods of oral administration are specified, but data is derived from sources using gavage.

Doses:

Primary data on lithium and benzoate salts include details of mortality at doses exceeding tolerated levels

Control animals:

not specified

Details on study design:

A review has been made based on a number of sources of information covering potassium and benzoate salts

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

LD50

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

Dose level causing mortality not estimated

Clinical signs:

other: Clinical signs of intoxication (for benzoates in rats) included diarrhoea, muscular weakness, tremors, hypoactivity and emaciation. No clinical signs of over exposure in humans has been reported.

Any other information on results incl. tables

The LD50 is estimated on the basis that potassium does not impact on the toxicity.

No further animal testing is justified and the substance need not be classified under CLP

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

The LD50 is estimated on the basis that potassium does not impact on the toxicity.
No further animal testing is justified and the substance need not be classified under CLP

Executive summary:

Potassium benzoate, sodium benzoate and benzoic acid have all been extensively reviewed by national and international agencies.