Tin(2+) neodecanoate

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

09.11.2017 - 15.02.2018

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:

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

Version / remarks:

February 2017

Deviations:

no

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 437 (Bovine Corneal Opacity and Permeability Test Method for Identifying Ocular Corrosives and Severe Irritants)

Version / remarks:

October 2007

Deviations:

no

GLP compliance:

yes (incl. QA statement)

Test material

Test material information

Constituent 1

Reference substance name:

Tin(2+) neodecanoate

EC Number:

256-370-0

EC Name:

Tin(2+) neodecanoate

Cas Number:

49556-16-3

Molecular formula:

C20H38O4Sn

IUPAC Name:

λ²-tin(2+) bis(2,2-dimethyloctanoate)

Test material form:

liquid

Test system

Vehicle:

physiological saline

Amount / concentration applied:

Each 0.75 mL of the undiluted test item were applied to three bovine corneas.

Duration of treatment / exposure:

The corneas were exposed to the test item solution for 10 minutes.

Number of animals or in vitro replicates:

3 corneas per group (test item, negative control, positive control)

Details on study design:

Three corneas were epxosed to each 0.75 mL of the undiluted test item in physiological saline. After treatment the test item solution was rinsed off the corneas and they were incubated for further 2 hours. After the 2 hours incubation the cornea's opacity was determined. In a second step the permeability of the corneas was determined phototometrically after 90 minutes treatment with fluorescein solution.

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

cornea opacity score

Value:

6.334

Negative controls validity:

valid

Positive controls validity:

valid

Results 2

Irritation parameter:

other: Permeability score

Value:

0.009

Negative controls validity:

valid

Positive controls validity:

valid

Results 3

Irritation parameter:

in vitro irritation score

Value:

6.469

Negative controls validity:

valid

Positive controls validity:

valid

In vivo

Irritant / corrosive response data:

Following treatment with Neodecanoic acid, tin(2+) salt (2:1) a mean opacity of 6.334 ± 3.037 and a mean permeability value of 0.009 ± 0.004 compared to the negative control were determined. The calculated IVIS of 6.469 ± 3.052 is above the cut-off value of 3 (UN GHS no category) and below the cut-off value of 55, identifying test substances as inducing serious eye damage (UN GHS Category 1). Consequently no prediction concerning irritant or severely irritant potential of the test item can be made.

Any other information on results incl. tables

Results after 10 Minutes Incubation Time:

	Cornea No.	Opacity	Permeability	IVIS
				Per Cornea	Per Group
					Mean	SD
0.9% NaCl	1	-0.478	0.011	-0.313	-0.119	0.194
	2	0.000	0.005	0.075
	3	-0.119	0.000	-0.119
1% NaOH	4	76.136	1.578	99.806	89.898	8.947
	5	64.980	1.500	87.480
	6	57.569	1.656	82.409
Neodecanoic acid, tin(2+) salt (2:1)	7	9.840	0.010	9.990	6.469	3.052
	8	4.502	0.005	4.577
	9	4.661	0.012	4.841

SD: Standard deviation

Applicant's summary and conclusion

Interpretation of results:

other: no prediction concerning irritant or severely irritant potential of the test item can be made

Remarks:

Criteria used for interpretation of results: other: CLP, EU GHS (Regulation (EC) No 1272/2008)

Conclusions:

Under the present test conditions Neodecanoic acid, tin(2+) salt (2:1) tested in the in vitro BCOP test method, had an IVIS value of 6.469, which is above the cut-off value of 3 (UN GHS no category) and below the cut-off value of 55, identifying test substances as inducing serious eye damage (UN GHS Category 1). Consequently no prediction concerning irritant or severely irritant potential of the test item can be made.

Executive summary:

The purpose of this study was to determine the ocular irritancy potential of Neodecanoic acid, tin(2+) salt (2:1) in an in vitro system. The Bovine Corneal Opacity and Permeability Assay (BCOP) test method is an organotypic model that provides short-term

maintenance of normal physiological and biochemical function of the bovine cornea in vitro. In this test method, possible damage by the test item was assessed by quantitative measurements of changes in corneal opacity and permeability in

isolated corneas from bovine eyes.

Three corneas were used for each treatment group (test item, negative control and positive control). The liquid test item Neodecanoic acid, tin(2+) salt (2:1) was used undiluted as recommended in the test guideline OECD 437. 0.9% NaCl solution was used as the

negative control and 1% NaOH in water (highly purified water) as the positive control item.

The test and control items were applied to the epithelial surface of the cornea by addition to the anterior chamber of the corneal holder. The exposure time for the test item and the controls was 10 minutes. The optical density (OD) was

measured at a wavelength of 490 nm.

The acceptance criteria of validity were fulfilled in this test.

Following treatment with Neodecanoic acid, tin(2+) salt (2:1) a mean opacity of 6.334 ± 3.037 and a mean permeability value of 0.009 ± 0.004 compared to the negative control were determined. The calculated IVIS of 6.469 ± 3.052 is above the cut-off value of 3

(UN GHS no category) and below the cut-off value of 55, identifying test substances as inducing serious eye damage (UN GHS Category 1). Consequently no prediction concerning irritant or severely irritant potential of the test item can be made.