[No public or meaningful name is available]

Eye irritation

Administrative data

Endpoint:

eye irritation: in vitro / ex vivo

Type of information:

experimental study

Adequacy of study:

key study

Study period:

2012-05-17

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2012

Report date:

2012

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)

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:

Tellurium dioxide

EC Number:

231-193-1

EC Name:

Tellurium dioxide

Cas Number:

7446-07-3

Molecular formula:

O2Te

IUPAC Name:

oxotellane oxide

Test material form:

solid: particulate/powder

Details on test material:

lot/batch No.of test material: EK1008F023

Test animals / tissue source

Details on test animals or tissues and environmental conditions:

Species of chicken: ROSS 308
Source: TARAVIS KFT. 9600 Sárvár, Rábasömjéni út. 129.

Chicken heads were collected after slaughter in a commercial abattoir from chickens which are used for human consumption. Heads were collected
by a slaughter house technician. After collection, the heads were inspected for appropriate quality and wrapped with paper moistened with saline,
then placed in a plastic box that can be closed (4-5 heads/box).
The heads were transported to CiToxLAB Hungary Ltd. at ambient temperature at the earliest convenience.
The heads were received at CiToxLAB Hungary Ltd. and processed within approximately 2 hours of collection.

Test system

Vehicle:

unchanged (no vehicle)

Details on study design:

Classification according to GHS Classification:

Not irritating
3×I
2×I, 1×II
2xII, 1xI

Slightly irritating
(GHS category 2B: Mild irritant / causes eye irritation)
3×II
2×II, 1×III
1×I, 1×II, 1×III

Moderately irritating
(GHS category 2A: Irritant / causes eye irritation)
3×III
2×III, 1×II
2xI, 1xIV
2×III, 1×IV
2×III, 1×I
2×II, 1×IV
1×II, 1×III, 1×IV

Corrosive/severely irritating
(GHS category 1: Irreversible effects on the eye / serious damage to the eye)

3×IV
2×IV, 1×III
2×IV, 1×II
2×IV, 1×I
Corneal opacity ≥ 3 at 30 min (in at least 2 eyes)
Corneal opacity = 4 at any time point (in at least 2 eyes)
Severe loosening of epithelium (in at least 1 eye)

Results and discussion

In vitro

Results

Results 1

Irritation parameter:

percent corneal swelling

Run / experiment:

mean maximum change up to 75 minutes

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

ICE class I

Results 2

Irritation parameter:

percent corneal swelling

Run / experiment:

mean maximum up to 240 minutes

Value:

0

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

ICE class I

Results 3

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:

no indication of irritation

Remarks:

ICE class I

Results 4

Irritation parameter:

fluorescein retention score

Run / experiment:

mean

Value:

0.5

Vehicle controls validity:

not applicable

Negative controls validity:

valid

Positive controls validity:

valid

Remarks on result:

no indication of irritation

Remarks:

ICE class I

Other effects / acceptance of results:

The Test Item was stuck on the cornea surface after the post-treatment rinse. The cornea surface was not cleared 240 min after the
post-treatment rinse.

Any other information on results incl. tables

 

 

	Corneal thickness (instrument units) Relative observation time (min)
Eye No.	-45 min	0	Change	30	75	Max change < 75	120	180	240	Max change < 240
1	86	86	0 %	86	86	0 %	86	86	86	0 %
3	87	86	-1 %	86	86	0 %	86	86	86	0 %
4	86	86	0 %	87	87	1 %	87	87	87	1 %
NC	86	86	0 %	86	86	0 %	86	86	86	0 %

 

 

 

	Corneal opacity score Relative observation time (min)
Eye No.	0	30	75	120	180	240	Max ∆ Opac
1	0	0	0	0	0	0	0
3	0	0	0	0	0	0	0
4	0	0	0	0	0	0	0
NC	0	0	0	0	0	0	0

 

 

	Fluorescein Relative observation time (min)
Eye No.	0	30
1	0	0.5
3	0	0.5
4	0	0.5
NC	0	0

 

 

 NC = negative control

 

POSITIVE CONTROL

Observation	Value		ICE Class*
Mean maximum corneal swelling at up to 75 min	4 %		I
Mean maximum corneal swelling at up to 240 min	7 %		II
Mean maximum corneal opacity	4.00		IV
Mean fluorescein retention	2.83		IV
Other Observations		The Imidazole was stuck on the cornea surface after the post-treatment rinse. The cornea surface was not cleared 240 minutes after the post-treatment rinse.
Overall ICE Class*		1xII 2xIV

  The positive control Imidazole was classed as severely irritating, GHS Classification: Category 1.

Applicant's summary and conclusion

Interpretation of results:

GHS criteria not met

Remarks:

Criteria used for interpretation of results: expert judgment

Conclusions:

In this in vitro eye irritation study in the Isolated Chicken Eyes model with Tellurium dioxide, the results suggest that the test item is not a severe eye irritant. Tellurium dioxide remained adhered to the cornea surface after the post-treatment rinse.

Executive summary:

An in vitro eye irritation study of the test item Tellurium dioxide was performed in isolated chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No.: 438 (07th September 2009).

After the zero reference measurements, the eye was held in horizontal position and 30 mg of Tellurium dioxide was applied onto the centre of the cornea such that the entire surface of the cornea was covered. After 10 seconds, the surface was rinsed with saline. The positive control eyes were treated with 30 mg Imidazole. The negative control eye was treated with 30 μL of isotonic saline.

In this in vitro eye irritation study in the Isolated Chicken Eyes model with Tellurium dioxide, the results suggest that the test item is not a severe eye irritant. Tellurium dioxide remained adhered to the cornea surface after the post-treatment rinse.