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EC number: 236-813-4 | CAS number: 13494-80-9
- Life Cycle description
- Uses advised against
- Endpoint summary
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- Endpoint summary
- Stability
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- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
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- Long-term toxicity to aquatic invertebrates
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- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- Additional toxicological data

Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vitro / ex vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2012-05-15
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 012
- Report date:
- 2012
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
- 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
- Reference substance name:
- Tellurium
- EC Number:
- 236-813-4
- EC Name:
- Tellurium
- Cas Number:
- 13494-80-9
- Molecular formula:
- Te
- IUPAC Name:
- hydrogen telluride
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Tellurium powder
- Substance type: inorganic
Constituent 1
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 validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class I
- Irritation parameter:
- other: maximum corneal swelling
- Run / experiment:
- up to 240 min
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class I
- Irritation parameter:
- cornea opacity score
- Run / experiment:
- maximum
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class I
- Irritation parameter:
- fluorescein retention score
- Run / experiment:
- 30 min.
- Value:
- 0
- Negative controls validity:
- valid
- Positive controls validity:
- valid
- Remarks on result:
- other: ICE class I
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.
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