Bis(8-hydroxyquinolinium) sulphate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

From May 24th to June 15th, 2018

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

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:

09 October 2017

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Bis(8-hydroxyquinolinium) sulphate

EC Number:

205-137-1

EC Name:

Bis(8-hydroxyquinolinium) sulphate

Cas Number:

134-31-6

Molecular formula:

C9H7NO.1/2H2O4S

IUPAC Name:

bis(8-hydroxyquinolinium) sulphate

Test animals / tissue source

Species:

cattle

Details on test animals or tissues and environmental conditions:

TEST ANIMALS
- Source: bovine eyes were obtained from freshly slaughtered cattle at the abattoir EVA, Saint-Pierre-sur-Dives, France.
- Age at study initiation: as French Authorities avoid the use of any organs from the head of bovines aged more than 12 months, bovine cattle were up to 12 months old (typically, 5 to 8 months old).

Test system

Vehicle:

physiological saline

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

TEST MATERIAL
- Concentration (if solution): 20% (w/v) in 0.9% NaCl

VEHICLE
- Concentration (if solution): 0.9% NaCl

Duration of treatment / exposure:

4-hour treatment

Number of animals or in vitro replicates:

3 replicates for test item, vehicle and positive control.

Details on study design:

REMOVAL OF TEST SUBSTANCE
- Washing: on completion of the treatment period, the test item formulation was removed from the front opening of the anterior chamber (closed-chamber method) and the epithelium was rinsed as follows:
. the anterior chamber was emptied using a metal gavage tube attached to a vacuum pump,
. the corneas were rinsed three times with pre-warmed cMEM containing phenol red (i.e. until the test item formulation had been completely removed from the chamber or until the phenol red was not discoloured). Then, the corneas were finally rinsed with pre-warmed cMEM without phenol red.
The rinsing efficiency was visually confirmed by observing the transparency and the colour changing of the rinsing medium (containing phenol red). No difficulties were encountered during the rinsing.

SCORING SYSTEM: spectrophotometric measurements evaluated at 490 nm are recorded as optical density (OD490)

TOOL USED TO ASSESS SCORE: fluorescein

Results and discussion

In vitro

Results

Irritation parameter:

in vitro irritation score

Run / experiment:

test item

Value:

134

Vehicle controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

ACCEPTANCE OF RESULTS:
All acceptance criteria were fulfilled. The study was therefore considered as valid.

Applicant's summary and conclusion

Interpretation of results:

Category 1 (irreversible effects on the eye) based on GHS criteria

Conclusions:

The mean In Vitro Irritancy Score (IVIS) of the test item-treated corneas was: 134.

Executive summary:

The mean In Vitro Irritancy Score (IVIS) of the test item-treated corneas was: 134.

As the mean IVIS was > 55, the test item was considered as a test chemical inducing serious eye damage (UN GHS Category 1).