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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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: Well documented and scientifically good . Tests done according to standard protocol.

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2011
Report Date:
2011

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Name of test material: Cadmium telluride
Physical state: Black solid
Purity: > 99.99%
Batch number: 138683
Expiry date: 2 years from the first opening (24 May 2011) if kept under inert atmosphere (e.g. nitrogen)
Storage conditions: 20 ±5ºC under inert gas (e.g. nitrogen)

Test animals / tissue source

Species:
other: in vitro in isolated chicken eyes
Strain:
other: not applicable
Details on test animals or tissues and environmental conditions:
not applicable

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: not applicable
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 30mg


Duration of treatment / exposure:
10 seconds
Observation period (in vivo):
up to 240 minutes (at 30, 75, 120, 180 and 240 min) after post-treatment rinse for the cornea thickness and cornea opacity
Fluorescein retention was measured at base line (t=0) and at 30 minutes after rinse.
Number of animals or in vitro replicates:
not applicable
Details on study design:
treatments:
-test substance treated chicken eye: treated with 30 mg CdTe
-positive control chicken eye: treated with 30 mg imidazole
-negative control eye: treated with 30µL isotonic saline

REMOVAL OF TEST SUBSTANCE
- Washing (if done): cornea surface was rinsed thoroughly with 20ml isotonic saline
- Time after start of exposure: after 10'' of exposure

SCORING SYSTEM:
The control eye and test eyes were evaluated pre-treatment and at approximately 30, 75, 120, 180 and 240 minutes after the post-treatment rinse.
Minor variations within ±5 minutes were considered acceptable.

The cornea thickness and cornea opacity were measured at all time points.
Fluorescein retention was measured on two occasions, at base line (t=0) and 30 minutes after the post-treatment rinse.


TOOL USED TO ASSESS SCORE: hand-slit lamp / biomicroscope/fluorescein

Results and discussion

In vitro

Resultsopen allclose all
Irritation parameter:
other: corneal thickness (%)
Run / experiment:
at up to 75 min
Value:
0
Irritation parameter:
other: corneal thickness (%)
Run / experiment:
at up to 240 min
Value:
0
Irritation parameter:
cornea opacity score
Run / experiment:
mean maximum
Value:
0.67
Irritation parameter:
fluorescein retention score
Run / experiment:
mean
Value:
1.83

Any other information on results incl. tables

The mean values of the treated eyes for maximum corneal thickness change, corneal opacity and fluorescein retention are given below. The conclusion on eye irritancy was based on the OECD guideline quantitative assessments.

Test Item: Cadmium telluride (CdTe)

Observation

Value

ICE Class*

Mean maximum corneal swelling at up to 75 min

0 %

I

Mean maximum corneal swelling at up to 240 min

0 %

I

Mean maximum corneal opacity

0.67

II

Mean fluorescein retention

1.83

III

Other Observations

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

Overall ICE Class*

1xI, 1xII, 1xIII,

In this in vitro eye irritation in the isolated chicken eyes test withCadmium telluride (CdTe),the results suggest that the test item was slightly irritating. The test item was not a severe irritant. No conclusion of in vivo significance can be made from the adherence of the test item to the cornea, since in vivo eye lids will probably clear the surface, but abrasion may occur. An in vivo study is required for classification.

Positive Control: Imidazole

Observation

Value

ICE Class*

Mean maximum corneal swelling at up to 75 min

4 %

I

Mean maximum corneal swelling at up to 240 min

10 %

II

Mean maximum corneal opacity

4.00

IV

Mean fluorescein retention

2.83

IV

Other Observations

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

Overall ICE Class*

1xII 2xIV

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

Negative Control: Sodium chloride

Observation

Value

ICE Class*

Mean maximum corneal swelling at up to 75 min

0 %

I

Mean maximum corneal swelling at up to 240 min

0 %

I

Mean maximum corneal opacity

0.00

I

Mean fluorescein retention

0.00

I

Other Observations

None

Overall ICE Class*

3xI

The negative control Sodium chloride 0.9% had no significant effects on the chicken eye in this study.

.

Table:Assessment of the general IN VITRO eye irritancy and regulatory GHS classification.

 

The following table is used to identify the probably eye irritancy potential of test items. In the case where the result indicates Corrosive/Severely Irritating, then the test item can be classified as Severe. In all other cases the probable level of irritancy can be reported, but a regulatory in vivo rabbit eye irritation test is required for regulatory classification and labelling purposes.

EC and GHS Classification

Combinations of the three ICE Classes

A=Not irritating

3×I

2×I, 1×II

2xII, 1xI4

B= Slightly irritating

(GHS3category 2B: Mild irritant / causes eye irritation)

3×II

2×II, 1×III

1×I, 1×II, 1×III1

C= Moderately irritating

(GHS3category 2A: Irritant / causes eye irritation)

3×III

2×III, 1×II

2xI, 1xIV1

2×III, 1×IV2

2×III, 1×I

2×II, 1×IV1

1×II, 1×III, 1×IV1

D= Corrosive/severely irritating

(GHS3category 1: Irreversible effects on the eye / serious damage to the eye)

3×IV

2×IV, 1×III

2×IV, 1×II1

2×IV, 1×I1

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)

Applicant's summary and conclusion

Interpretation of results:
other: slightly irritating
Conclusions:
In this in vitro eye irritation study in the Isolated Chicken Eyes model with Cadmium telluride (CdTe), the results suggests that the test item slightly irritating. According to the guideline OECD 438, Cadmium telluride (CdTe) does not require a classification as a severe eye irritant. Cadmium telluride (CdTe) was stuck on the cornea surface after the post-treatment rinse. An in vivo study is required for classification.
Executive summary:

An in vitro eye irritation study of the test item Cadmium telluride (CdTe)was performed in chicken’s eyes. The irritation effects of the test item were evaluated according to the OECD No.: 438 (07thSeptember 2009).

 

After the zero reference measurements, the eye was held in horizontal position and 30 mg of Cadmium telluride (CdTe) 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 in a similar way 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 Cadmium telluride (CdTe), the results suggests that the test item slightly irritating. According to the guideline OECD 438, Cadmium telluride (CdTe) does not require a classification as a severe eye irritant.Cadmium telluride (CdTe) was stuck on the cornea surface after the post-treatment rinse. An in vivo study is required for classification.