Potassium hydrogen phthalate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

03.09.2018 - 06.09.2018

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Qualifier:

according to guideline

Guideline:

OECD Guideline 492 (Reconstructed Human Cornea-like Epithelium (RhCE) Test Method for Identifying Chemicals Not Requiring Classification and Labelling for Eye Irritation or Serious Eye Damage)

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Potassium hydrogen phthalate

EC Number:

212-889-4

EC Name:

Potassium hydrogen phthalate

Cas Number:

877-24-7

Molecular formula:

C8H6O4.K

IUPAC Name:

phthalic acid

Test material form:

solid: crystalline

Test animals / tissue source

Species:

human

Details on test animals or tissues and environmental conditions:

The EpiOcularTM tissue consists of normal, human-derived keratinocytes, which have been cultured to form a stratified squamous epithelium similar to that found in the human cor-nea. It consists of highly organized basal cells. These cells are not transformed or trans-fected with genes to induce an extended life span.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

Tissue 1: 50.3 mg
Tissue 2: 51.6 mg

Duration of treatment / exposure:

6 h

Duration of post- treatment incubation (in vitro):

18 h

Number of animals or in vitro replicates:

2 replicates per treatment group

Results and discussion

In vitro

Results

Irritation parameter:

other: Cell viability in %

Run / experiment:

Mean value

Value:

1.7

Vehicle controls validity:

not examined

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

Under the conditions of the test, Potassium Hydrogen Phthalate is considered either eye irritant or inducing serious eye damage in the EpiOcularTM Eye Irritation Test.
According to the OECD Guideline 492, the EpiOcularTM Eye Irritation Test does not allow discrimination between eye irritation/reversible effects on the eye (Category 2) and serious eye damage/irreversible effects on the eye (Category 1). For these purposes, further testing with other suitable test methods is required.

Executive summary:

Under the conditions of the test, Potassium Hydrogen Phthalate is considered either eye irritant or inducing serious eye damage in the EpiOcularTM Eye Irritation Test.

After treatment with the test item, the mean value of relative tissue viability was reduced to 1.7 %. This value is well below the threshold for eye irritation potential (≤ 60 %).

All validity criteria were met. The criterion for optical density of the negative control was fulfilled: The OD value was 2.0 (> 0.8 and < 2.5).

The positive control induced a decrease in tissue viability as compared to the negative control to 28.0 %. Variation within the replicates of the controls and the test item was ac-ceptable (< 20 %).

For these reasons, the result of the test is considered valid.