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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:
2012-11-12 - 2012-12-07
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: The study was conducted according to an internationally accepted guideline. All study parameters are based on the specific guideline.

Data source

Reference Type:
study report
Report date:

Materials and methods

Test guideline
no guideline available
other: Human Cornea Model Test
GLP compliance:
yes (incl. QA statement)

Test material

Constituent 1
Chemical structure
Reference substance name:
Phenyl diamidophosphate
EC Number:
EC Name:
Phenyl diamidophosphate
Cas Number:
Molecular formula:
Test material form:
solid: crystalline
Details on test material:
Identity: PPDA
CAS-No.: 7450-69-3
EINECS-No.: 231-218-6
Molecular Formula: C6H9N2O2P
Purity: 92.4% (HPLC)

Test animals / tissue source

other: Human Cornea Model

Test system

Amount / concentration applied:
Each about 100 mg of the solid test item was applied to each of duplicate tissues, wetted with 30 µL of deionised water, and spread to cover the surface of the tissues evenly.
For the positive and negative controls 100 µL were dosed per tissue.
Duration of treatment / exposure:
3, 30 and 60 min.

Results and discussion

In vitro

Irritation parameter:
other: relative absorbance (%of negative control)
Run / experiment:
test item
Vehicle controls validity:
not applicable
Negative controls validity:
Positive controls validity:

Applicant's summary and conclusion

Interpretation of results:
moderately irritating
Migrated information Criteria used for interpretation of results: EU
In this study and under the experimental conditions reported, the test item PPDA possesses a moderate eye irritating potential.
Executive summary:

This in vitro study was performed to assess the eye irritation potential of PPDA by means of the Human Cornea Model Test.

Each about 100 mg of the solid test item was applied to each of duplicate tissues, wetted with 30 µL of deionised water, and spread to cover the surface of the tissues evenly.

100 µL of either the negative control (deionised water) or the positive control (0.3% Triton X-100) were applied to each tissue.

Tissues of the human cornea model EpiOcularwere treated with the test item for 3, 30 and 60 minutes in duplicate. The cells for the negative control were treated for 60 min and the positive control for 15 and 45 min each in duplicate.

After treatment with the negative control the absorbance values were well above the required acceptability criterion of mean OD≥0.8 for the60 minutestreatment interval thus showing the quality of the tissues.

Treatment with the positive control induced a decrease in the relative absorbance compared with the negative control to 64.5% (after 15 minutes treatment) or 26.3% (after 45 minutes treatment), respectively, thus ensuring the validity of the test system.

Compared with the result of the negative control, the relative absorbance values of the test item, corresponding to the cell viability, decreased after exposure to the cells. After the treatment period of 30 minutes, the cell viability was reduced to 22.0%, after 60 minutes only 16.1% of the cells survived. The 3-minutes exposure did not have any impact on the cell viability (103.7%).The calculated ET50-value was 20.7 minutes,consequently the test item was classified as moderate irritant.