Potassium benzoate

Endpoint summary

Description of key information

Assessment has been made based on the well established toxicity profile of benzoate (specifically sodium benzoate)

There is no evidence of toxicity from potassium at concentrations leading to classification.

Potassium is an essential element and there is a recommended daily intake of 4700 mg/day for adults (ca 67 mg/kg based on 70 kg adult). The recommended daily intake for children is > 70 mg/kg/day.

Key value for chemical safety assessment

Acute toxicity: via oral route

Link to relevant study records

Reference

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.

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

Species:

rat

Strain:

not specified

Sex:

male/female

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

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.

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

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. 

Endpoint conclusion

Endpoint conclusion:

adverse effect observed

Dose descriptor:

LD50

Value:

500 mg/kg bw

Quality of whole database:

Extensive reviews by national and international regulatory agencies on benzoate salts.

Acute toxicity: via inhalation route

Endpoint conclusion

Endpoint conclusion:

no study available

Acute toxicity: via dermal route

Endpoint conclusion

Endpoint conclusion:

no adverse effect observed

Dose descriptor:

discriminating dose

Value:

2 000 mg/kg bw

Additional information

There are limited data relating to dermal absorption of lithium and benzoate ions.

 

Benzoic acid and sodium benzoate have been assessed for acute dermal toxicity and these are not considered hazardous and are not classified.

 

One source of data is in the opinion of the scientific committee on cosmetic products and non-food products intended for consumers (European Commission 2002). This review is based on a number of primary sources of data and is considered sufficient to confirm that these salts are of low dermal toxicity.

 

No further animal testing can be justified.

Reviews have been found, published by:

 

World Health Organisation, International Programme on Chemical Safety (IPCS)

http://www.inchem.org/documents/cicads/cicads/cicad26.htm

 

Scientific Committee On Consumer Products, Opinion on Benzoic Acid and Sodium Benzoate, 2005

http://ec.europa.eu/health/ph_risk/committees/04_sccp/docs/sccp_o_015.pdf

 

SIDS INITIAL ASSESSMENT PROFILE: Benzoates, 2001

http://www.chemicals.moew.government.bg/chemical/site/File/registers/profile/BENZOATESp.pdf

http://www.inchem.org/documents/sids/sids/BENZOATES.pdf

  

Benzyl Alcohol, Benzoic Acid, and its Salts and Ester,  CIR Expert Panel Meeting 2011

http://www.cir-safety.org/sites/default/files/119_draft_benzyl.pdf

Justification for classification or non-classification

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

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.