Tetrazinc trioxide phosphite

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

21 November 2017 - 21 November 2017

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2018

Report date:

2018

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Version / remarks:

July, 2013

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.47 (Bovine corneal opacity and permeability test method for identifying ocular corrosives and severe irritants)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

Tetrazinc trioxide phosphite

EC Number:

264-938-4

EC Name:

Tetrazinc trioxide phosphite

Cas Number:

64539-51-1

Molecular formula:

HO6PZn4

IUPAC Name:

Tetrazinc trioxide phosphite

Specific details on test material used for the study:

Batch: 1013Q17761
Purity: 100%
Appearance: White powder
Expiry Date: 25 June 2017
Storage Conditions: At room temperature

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

Freshly isolated bovine cornea (at least 9 month old donor cattle).

Test system

Vehicle:

physiological saline

Remarks:

20% suspension (w/v)

Controls:

yes, concurrent vehicle

yes, concurrent positive control

Amount / concentration applied:

0.75 mL each on the surface of the corneae

Duration of treatment / exposure:

240 minutes

Number of animals or in vitro replicates:

Triplicate

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Value:

19.89

Vehicle controls validity:

valid

Negative controls validity:

not applicable

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Other effects / acceptance of results:

For the negative control (saline) neither an increase of opacity nor permeability of the corneae could be observed (mean IVIS = 1.00).
The positive control (10% (w/v) Benzalkonium chloride in saline) showed clear opacity and distinctive permeability of the corneae (mean IVIS =138.03) corresponding to a classification as serious eye damaging (CLP/EPA/GHS (Cat 1)).

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

Conclusions:

According to OECD 437 no prediction for the damage hazard of the substance to the eye can be made, but the substance is not serious eye damaging (CLP/EPA/GHS (Cat 1).

Executive summary:

The eye hazard potential of the substance as measured by its ability to induce opacity and increase permeability in an isolated bovine cornea was assessed using the Bovine Corneal Opacity and Permeability test (BCOP test). The eye damage of the substance was tested through topical application for approximately 240 minutes.  The substance did not induce ocular irritation through both endpoints (opacity and permeability), resulting in a mean in vitro irritancy score (IVIS) of 19.89 after 4 hours of treatment. In conclusion, since the substance caused an increase of the corneal opacity, according to OECD 437, no prediction for the damage hazard of the substance to the eye can be made, but the substance is not serious eye damaging (CLP/EPA/GHS (Cat 1).