Potassium benzoate

Skin irritation / corrosion

Administrative data

Endpoint:

skin irritation: in vitro / ex vivo

Type of information:

read-across based on grouping of substances (category approach)

Adequacy of study:

key study

Study period:

60 minute exposure

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Justification for type of information:

Study performed to guidelines under GLP conditions
The Potassium salt appears to be a less severe irritant to eyes than the concurrently tested Lithium salt; therefore, it is safe to consider this to be a suitable read-across model to allow classification as skin Irrit 2

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2017

Report date:

2017

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

EU Method B.46 (In Vitro Skin Irritation: Reconstructed Human Epidermis Model Test)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Lithium benzoate

EC Number:

209-042-6

EC Name:

Lithium benzoate

Cas Number:

553-54-8

Molecular formula:

C7H6O2.Li

IUPAC Name:

lithium benzoate

Specific details on test material used for the study:

Name Lithium benzoate
Batch no. 16B/02
Appearance white powder
Composition Lithium benzoate > 98%
Purity min. 98.0 %
Homogeneity homogeneous
Expiry date 09. Jun. 2019

In vitro test system

Test system:

human skin model

Source species:

human

Cell type:

non-transformed keratinocytes

Vehicle:

unchanged (no vehicle)

Details on test system:

The tissues were wetted with 25 µL Dulbecco’s Phosphate Buffered Saline (DPBS) buffer before applying the test item

Control samples:

yes, concurrent negative control

yes, concurrent positive control

Amount/concentration applied:

ca 25 mg applied and spread over surface of wetted tissue

Duration of treatment / exposure:

60 minutes

Duration of post-treatment incubation (if applicable):

23 hours at 37C

Number of replicates:

three

Results and discussion

In vitro

Results

Irritation / corrosion parameter:

% tissue viability

Value:

ca. 14

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

Range of viablity 13.8 - 14.4 % (mean 14.1%).
Positive control 3.5 - 3.9% (mean 3.7%)

Applicant's summary and conclusion

Interpretation of results:

Category 2 (irritant) based on GHS criteria

Conclusions:

The relative absorbance values were reduced to 14.1% after the treatment. This value is below the threshold for skin irritation (50%). Therefore, the test item is considered as irritant to skin. A corrosive test was performed on lithium benzoate and it is concluded that it is not Corrosive.

Executive summary:

Data for lithium and potassium benzoate indicates that there is the same level of potential irritation and read-across is valid.

Public data for potassium benzoate concludes it is non-corrosive.

It is concluded that potassium benzoate is Skin Irrit 2, Eye Dam 1