Copper, diamminebis(nitrato-kO)

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

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)

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

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

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Copper, diamminebis(nitrato-kO)

EC Number:

604-942-9

Cas Number:

15414-04-7

Molecular formula:

CuH6N4O6

IUPAC Name:

Copper, diamminebis(nitrato-kO)

Test animals / tissue source

Species:

chicken

Details on test animals or tissues and environmental conditions:

The eyes collected from chickens obtained from a slaughterhouse where they are killed for human consumption have been used for this assay.
The age and weight of the chickens used in this test method are that of spring chickens traditionally processed by a poultry slaughterhouse (i.e., approximately 7 weeks old, 1.5 - 2.5 kg).
Heads have been removed immediately after sedation of the chickens by electric shock, and incision of the neck for bleeding. Because eyes were dissected in the laboratory, the intact heads were transported from the slaughterhouse at ambient temperature in plastic boxes humidified with towels moistened with physiological saline. The eyes were thereafter enucleated.

Test system

Vehicle:

unchanged (no vehicle)

Controls:

yes, concurrent positive control

yes, concurrent negative control

Amount / concentration applied:

30 mg of the test item was applied

Duration of treatment / exposure:

during 10 seconds

Observation period (in vivo):

After the application of the test item, the eyes were rinsed with 40 mL of physiological saline. The product still stuck to the entire cornea in the three eyes and was finally removed using a physiological saline soaked cotton bud then rinsed again with 10 mL of physiological saline.

Number of animals or in vitro replicates:

3 enucleated chicken eyes

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Run / experiment:

mean

Value:

ca. 2.3

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation parameter:

fluorescein retention score

Run / experiment:

mean

Value:

ca. 2.3

Negative controls validity:

valid

Positive controls validity:

valid

Results 3

Irritation parameter:

percent corneal swelling

Run / experiment:

mean

Value:

ca. 3

Negative controls validity:

valid

Positive controls validity:

valid

Other effects / acceptance of results:

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.

Any other information on results incl. tables

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

- maximal mean score of corneal opacity: 2.3, corresponding to ICE class III;

- mean score of fluorescein retention: 2.3, corresponding to ICE class III;

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

The combination of the three endpoints for the test item MNP-363H was 2 x III, 1 x I.

Applicant's summary and conclusion

Interpretation of results:

study cannot be used for classification

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 MNP-363H is not predicted as causing serious eye damage (Category 1) or as not classified for eye irritation/serious eye damage (No category) with the Isolated Chicken Eye test method. Additional testing (in vitro and/or in vivo) are required to establish a definitive classification.