Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Remarks:

artificial human 3D-Cornea model

Type of information:

experimental study

Adequacy of study:

key study

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

other: GLP guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Principles of method if other than guideline:

In vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model. The model used is standardized and commercially available (SkinEthic™ Human Corneal Epithelial Model (HCE); SkinEthic, France).

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

EC Number:

266-442-3

EC Name:

Tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

Cas Number:

66669-53-2

Molecular formula:

C7H7Na4O9P

IUPAC Name:

tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate

Details on test material:

Content: 90.2%

Test animals / tissue source

Species:

other: not applicable - human corneal epithelial model (HCE)

Strain:

other: not applicable - human corneal epithelial model (HCE)

Test system

Vehicle:

other: not applicable - human corneal epithelial model (HCE)

Controls:

other: not applicable - human corneal epithelial model (HCE)

Duration of treatment / exposure:

After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was measured

Observation period (in vivo):

not applicable - human corneal epithelial model (HCE)

Number of animals or in vitro replicates:

not applicable - human corneal epithelial model (HCE)

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Remarks:

Cell viability

Run / experiment:

mean value

Value:

84.62

Vehicle controls validity:

valid

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Any other information on results incl. tables

A test substance is predicted to be an ocular irritant if the mean relative tissue viability (%) exposed to the test substance is <50%.

As can be seen from the information in the Table below the test substance tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate was not detected as positive in this test model.

Compound                     Cell viability [%]       Evaluation

Test item                          84.62                non-irritant

Positive control                     26.83                   irritant

Negative control               100.00               non-irritant

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Executive summary:

This in vitro study for assessing ocular irritation of compounds using a human epithelial corneal cell model was performed in 2012. The model used is standardized and commercially available (SkinEthicTM Human Corneal Epithelial Model (HCE); SkinEthic, France).

Undiluted tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate was applied topically to the HCE tissue, i.e. 30 mg per insert (plus 30 µl PBS to moisten and ensure good contact with the skin; three replicates).

After an exposure period of 60 minutes, followed by a 16 hours post-treatment incubation period, the cell viability was 85% (rounded) as measured by a MTT conversion assay.

The results of the concurrent negative (NC, PBS) and positive control (PC, 1H-1,2,4-Triazole-3-thiol) demonstrated the viability (NC) and sensitivity (PC) of the test model.

The results show that tetrasodium hydrogen 2-phosphonatobutane-1,2,4-tricarboxylate is predicted as non-irritant under the conditions of this test method.