Zinc bis(hydroxymethanesulphinate)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

9 July 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

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying i) Chemicals Inducing Serious Eye Damage and ii) Chemicals Not Requiring Classification for Eye Irritation or Serious Eye Damage)

Test guideline 2

Qualifier:

according to guideline

Guideline:

EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Zinc bis(hydroxymethanesulphinate)

EC Number:

246-515-6

EC Name:

Zinc bis(hydroxymethanesulphinate)

Cas Number:

24887-06-7

Molecular formula:

C2H6O6S2Zn

IUPAC Name:

zinc bis(hydroxymethanesulphinate)

impurity 1

Reference substance name:

Zinc sulphite

EC Number:

237-046-8

EC Name:

Zinc sulphite

Cas Number:

13597-44-9

Molecular formula:

H2O3S.Zn

IUPAC Name:

zinc sulfite

Test material form:

solid: particulate/powder

Details on test material:

white crystalline powder
purity: 98.6%
pH of 10% solution: 4.10
bulk density: 1.35

Specific details on test material used for the study:

Batch no 515

Test animals / tissue source

Species:

chicken

Details on test animals or tissues and environmental conditions:

Eyes collected from chickens obtained from a slaughterhouse (Etablissement Brun, 33820 Etauliers, France) where they were killed for human consumption have been used for this assay. Heads have been removed immediately after sedation of the chickens by electric shock, and incision of the neck for bleeding. The intact heads were transported from the slaughterhouse at ambient temperature in plastic boxes humidified with towels moistened with physiological saline. The eyes were enucleated at Phycher afterwards.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

30 mg per eye

Duration of treatment / exposure:

10 seconds

Duration of post- treatment incubation (in vitro):

240 minutes

Number of animals or in vitro replicates:

3 eyes for the test item, 1 eye for negative control, 3 eyes for positive controls

Details on study design:

Damages by the test item were assessed by determination of corneal swelling, opacity, and fluorescein retention at 30, 75, 120 180 and 240 minutes post-dose.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Run / experiment:

Mean

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: ICE Class I

Results 2

Irritation parameter:

fluorescein retention score

Run / experiment:

Mean

Value:

1.7

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: ICE Class III

Results 3

Irritation parameter:

percent corneal swelling

Run / experiment:

Mean

Value:

3

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

other: ICE Class I

Other effects / acceptance of results:

The combination the three endpoints for the test item was 1 x III, 2 x I.

The combination of the three endpoints for the positive control, Sodium hydroxide, was 3 x IV. Therefore, the positive control is classified as "Corrosive/Severe Irritant", as expected.

The combination of the three endpoints for the negative control, physiological saline, was 3 x I. Therefore, the negative control is classified as "No Category", as expected.

Applicant's summary and conclusion

Interpretation of results:

other: no prediction can be made

Conclusions:

In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions lead to the category "no prediction can be made", as defined by the OECD Guideline No 438. Therefore the test item is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serieous eye damage (No category) with the Isolated Chicken eye test method.

Executive summary:

The aim of the study was to evaluate the possible ocular corrosive or severe irritating effects of the test item after administration on enucleated chicken eyes.

The test item ZINC FORMALDEHYDE SULFOXYLATE was applied, after being reduced in fine powder, at the dose of 30 mg, to 3 enucleated chicken eyes, during 10 seconds. Then the eyes were rinsed twice with 10 mL of physiological saline. Three eyes were treated in the same manner with a positive control and one eye with a negative control. Damages by the test item were assessed by determination of corneal swelling, opacity, and fluorescein retention at 30, 75, 120 180 and 240 minutes post-dose. The test experimental protocol was established in accordance with OECD 438 and test method B.48.

The ocular reactions observed in eyes treated with the test item were:

- maximal mean score of corneal opacity: 0.0, corresponding to ICE Class I;

- mean score of fluorescein retention: 1.7, corresponding to ICE Class III;

- maximal mean corneal swelling: 3%, corresponding to ICE Class I.

The combination the three endpoints for the test item was 1 x III, 2 x I.

The combination of the three endpoints for the positive control, Sodium hydroxide, was 3 x IV. Therefore, the positive control is classified as "Corrosive/Severe Irritant", as expected.

The combination of the three endpoints for the negative control, physiological saline, was 3 x I. Therefore, the negative control is classified as "No Category", as expected.

In accordance with the Regulation (EC) No. 1272/2008, the results obtained under these experimental conditions lead to the category "no prediction can be made", as defined by the OECD Guideline No 438. Therefore the test item is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serieous eye damage (No category) with the Isolated Chicken Eye test method.