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Toxicological information

Eye irritation

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Administrative data

Endpoint:
eye irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-05-15
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2012
Report Date:
2012

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
Qualifier:
according to
Guideline:
EU method B.48 (Isolated chicken eye test method for identifying occular corrosives and severe irritants)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report): Tellurium powder
- Substance type: inorganic

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:
Assessment of the general IN VITRO eye irritancy and regulatory 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, 1xIV1
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

Resultsopen allclose all
Irritation parameter:
other: maximum corneal swelling
Run / experiment:
up to 75 min
Value:
0
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: ICE class I
Irritation parameter:
other: maximum corneal swelling
Run / experiment:
up to 240 min
Value:
0
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: ICE class I
Irritation parameter:
cornea opacity score
Run / experiment:
maximum
Value:
0
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: ICE class I
Irritation parameter:
fluorescein retention score
Run / experiment:
30 min.
Value:
0
Negative controls valid:
yes
Positive controls valid:
yes
Remarks on result:
other: ICE class I

In vivo

Irritant / corrosive response data:
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

88

87

-1 %

88

87

1 %

87

87

87

1 %

4

86

86

0 %

86

86

0 %

86

86

86

0 %

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

3

0

0

4

0

0

NC

0.5

0.5

 NC = negative control

 

POSITIVE CONTROL

Observation

Value

ICE Class*

Mean maximum corneal swelling at up to 75 min

3 %

I

Mean maximum corneal swelling at up to 240 min

7 %

II

Mean maximum corneal opacity

3.83

IV

Mean fluorescein retention

2.67

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:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: expert judgment
Conclusions:
In this in vitro eye irritation study in the Isolated Chicken Eyes model with Tellurium powder, the results suggest that the test item is not a severe eye irritant. Tellurium powder remained adhered to the cornea surface after the post-treatment rinse.
Executive summary:

An in vitro eye irritation study of the test item Tellurium 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 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, the results suggest that the test item is not a severe eye irritant, all scores were zero. Tellurium remained adhered to the cornea surface after the post-treatment rinse.