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Diss Factsheets

Toxicological information

Eye irritation

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Administrative data

eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
03.09.2018 - 06.09.2018
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
according to 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:

Test material

Constituent 1
Chemical structure
Reference substance name:
Potassium hydrogen phthalate
EC Number:
EC Name:
Potassium hydrogen phthalate
Cas Number:
Molecular formula:
phthalic acid
Test material form:
solid: crystalline

Test animals / tissue source

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

unchanged (no vehicle)
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

Irritation parameter:
other: Cell viability in %
Run / experiment:
Mean value
Vehicle controls validity:
not examined
Negative controls validity:
Positive controls validity:
Remarks on result:
positive indication of irritation

Applicant's summary and conclusion

Interpretation of results:
study cannot be used for classification
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.