Phenyl diamidophosphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-11-12 - 2012-12-07

Reliability:

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

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Qualifier:

no guideline available

Guideline:

other: Human Cornea Model Test

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Phenyl diamidophosphate

EC Number:

231-218-6

EC Name:

Phenyl diamidophosphate

Cas Number:

7450-69-3

Molecular formula:

C6H9N2O2P

IUPAC Name:

[(diaminophosphoryl)oxy]benzene

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

Species:

other: Human Cornea Model

Test system

Vehicle:

water

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

Results

Irritation parameter:

other: relative absorbance (%of negative control)

Run / experiment:

test item

Value:

16.1

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Applicant's summary and conclusion

Interpretation of results:

moderately irritating

Remarks:

Migrated information Criteria used for interpretation of results: EU

Conclusions:

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 EpiOcular^™were 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.