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Diss Factsheets

Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Remarks:
The EpiOcularTM (EIT)predicts acute eye hazard potential of chemicals by measurement of tissue damage caused by cytotoxic effects in reconstructed human cornea-like tissue model. It can be used as a replacement of the in vivo Draize Eye Irritation Test.
Type of information:
experimental study
Adequacy of study:
key study
Study period:
Study Plan Dated: 27 March 2019 Experimental Starting Date: 1. April 2019 Experimental Completion Date: 4. April 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2020
Report date:
2020

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)
Version / remarks:
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
Deviations:
no
GLP compliance:
yes (incl. QA statement)
Remarks:
Please find "Attached fully study report"

Test material

Constituent 1
Chemical structure
Reference substance name:
Sodium phenylphosphinate
EC Number:
224-305-5
EC Name:
Sodium phenylphosphinate
Cas Number:
4297-95-4
Molecular formula:
C6H7O2P.Na
IUPAC Name:
sodium phenylphosphinate
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
Test Item
Designation in Test Facility: 19022101G
Date of Receipt: 21. Feb. 2019
Condition at Receipt Room temperature, in proper conditions
Specification
The following information concerning identity and composition of the test item was provided by the sponsor.
Name Sodium phenylphosphinate
Batch no. 20190104
Appearance white powder
Composition approx. 98 % Sodium phenylphosphinate, approx. 1.5 % phenylphosphonic acid, approx. 0.5 % others
Purity 98%
Homogeneity homogeneous
Expiry date 15. Jan. 2020
Storage Room temperature (20 ± 5°C)

The following additional information was relevant to the conduct of the study according to OECD 492 and provided by the sponsor:
CAS No. 4297-95-4
EC-No. 224-305-5
Chemical Class not stated
Volatility not stated
pH-value not stated
LogP not stated
Molecular weight 194.07 g/mol
Stability H2O: not stated; EtOH: not stated; acetone: not stated; CH3CN: not stated; DMSO: not stated
Structural Formula
SMILES Code not stated

Storage
The test item was stored in the test facility in a closed vessel at room temperature (20±5°C).

Results and discussion

In vitro

Results
Irritation parameter:
in vitro irritation score
Run / experiment:
EpiOcularTM Eye Irritation Test
Value:
8.5
Vehicle controls validity:
not specified
Negative controls validity:
valid
Remarks:
The criterion for optical density of the negative control was fulfilled: The OD value was 1.6 (> 0.8 and < 2.5).
Positive controls validity:
valid
Remarks:
The positive control induced a decrease in tissue viability as compared to the negative control to 39.5%. Variation within the replicates of the controls and the test item was acceptable (< 20%).
Remarks on result:
positive indication of irritation
Remarks:
Under the conditions of the test, Sodium phenylphosphinate is considered either eye irritant or inducing serious eye damage in the EpiOcularTM Eye Irritation Test

Applicant's summary and conclusion

Interpretation of results:
other: At least eye irritant
Remarks:
No prediction can be made (category 1 or 2) - further testing is requierd
Conclusions:
Under the conditions of the test, Sodium phenylphosphinate is considered either eye irritant or inducing serious eye damage in the EpiOcularTM Eye Irritation Test.

Executive summary:

One valid experiment was performed.

The test item Sodium phenylphosphinate was applied to a three-dimensional human cornea tissue model in duplicate for an exposure time of 6 hours.

After treatment, the respective substance was rinsed from the tissue; then, cell viability of the tissues was evaluated by addition of MTT, which can be reduced to formazan. The formazan production was evaluated by measuring the optical density (OD) of the resulting solution.

Demineralised water was used as negative control and methyl acetate was used as positive control.

The controls showed the following results: After treatment with the negative control, the absorbance values were within the required acceptability criterion of mean OD > 0.8 and < 2.5, OD was 1.6. The positive control showed clear eye irritating effects, the mean value of the relative tissue viability was 39.5 % (< 50%).  

The variation within tissue replicates of the controls and the test item was acceptable (< 20%).

After treatment with the test item, the mean value of relative tissue viability was 8.5 %.  This value is below the threshold for eye irritation potential (≤ 60%). Test items that induce values below the threshold are either eye irritant or inducing serious eye damage.

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.

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