Potassium benzoate

Acute Toxicity: dermal

Administrative data

Endpoint:

acute toxicity: dermal

Type of information:

calculation (if not (Q)SAR)

Adequacy of study:

key study

Study period:

Acute single dose

Reliability:

2 (reliable with restrictions)

Rationale for reliability incl. deficiencies:

data from handbook or collection of data

Justification for type of information:

Limited testing has been performed to avoid new animal testing. Research into the substance suggests very little evaluation of the toxicity of this specific salt, but sodium benzoate or benzoic acid are well evaluated for drug and food uses. 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. No further animal testing can be justified

Data source

Reference

Reference Type:

other company data

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

no guideline followed

Version / remarks:

Assessment of published data and read-across

Principles of method if other than guideline:

Published data on the toxicity of benzoic acid and the salts, has been assessed
In view of the absence of toxicological findings, there is good confidence that potassium benzoate can be assessed as non-classified.

GLP compliance:

not specified

Test type:

standard acute method

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:

Not specified

Test animals

Species:

rat

Strain:

not specified

Sex:

not specified

Details on test animals or test system and environmental conditions:

Details are not specified in the review documents

Administration / exposure

Type of coverage:

not specified

Vehicle:

not specified

Details on dermal exposure:

The review documents did not specify details of coverage

Duration of exposure:

Not specified

Results and discussion

Effect levels

Key result

Sex:

male/female

Dose descriptor:

discriminating dose

Effect level:

> 2 000 mg/kg bw

Based on:

test mat.

Mortality:

There was no evidence of mortality in tests on Lithium carbonate, sodium benzoate or benzoic acidIt can be concluded that lithium banzoate is non-hazardous at up to the classification limit of 2000 mg/kg

Clinical signs:

other: There was no evidence of adverse effects in tests on Lithium carbonate, sodium benzoate or benzoic acidIt can be concluded that lithium banzoate is non-hazardous at up to the classification limit of 2000 mg/kg Note that Lithium Benzoate has been indicated

Other findings:

No advsere effects reported

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Conclusions:

Non-hazardous based on assessment of lithium carbonate, sodium benzoate and benzoic acid

Executive summary:

There was no evidence of toxic adverse effects in tests on Lithium carbonate, sodium benzoate or benzoic acid It can be concluded that lithium banzoate is non-hazardous at up to the classification limit of 2000 mg/kg in terms of toxic reponse.

However, in view of the positive in-vitro skin irritation study (Skin Irrit 2) it is likely that advsere local effects would be observed if testing was performed on live animals. This is further justification not to perform this test as would lead to animal suffering.