Registration Dossier

Administrative data

Description of key information

The read across for Cadmium selenide (CAS: 1306-24-7 / EC: 215-148-3); is based upon the analogous substances to which basic form, degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of skin and eye irritation/corrosion. Based on the information available for the read across substances, the substance is not expected to be irritating or corrosive to skin or eyes.

Key value for chemical safety assessment

Skin irritation / corrosion

Link to relevant study records

Referenceopen allclose all

Endpoint:
skin irritation: in vitro / ex vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-02-03 to 2010-02-05
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to same study
Qualifier:
equivalent or similar to
Guideline:
OECD Guideline 439 (In Vitro Skin Irritation: Reconstructed Human Epidermis Test Method)
Deviations:
no
Qualifier:
according to
Guideline:
other: "Commission Regulation (EC) No. 440/2008 B 46"
Deviations:
no
Qualifier:
according to
Guideline:
other: ECVAM international validation study on in vitro tests for acute skin irritation (Altern Lab Anim. 2007 Dec; 35 (6):559-601)
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
signed 2009-03-30
Details on test animals and environmental conditions:
not applicable- Since this is an in vitro study there is no information on test animals.
Vehicle:
unchanged (no vehicle)
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 15 mg of the test item were applied to each tissue (≙ 39.47 mg/cm2), spread to match the tissue size.
No further information on the amount/concentration applied was stated.
Duration of treatment / exposure:
15± 1 min
Observation period:
not applicable
Number of animals:
not applicable
Details on study design:
This in vitro study was performed to assess the irritation potential of Zinc selenite by means of the Human Skin Model Test. Three tissues of the human skin model EpiSkin™ (Lot No.: 10-EKIN-003) were treated with either the test item, the negative or the positive control.

CELL CULTURE
EpiSkin™ kits are purchased from Skinethic Laboratories (06000 Nice, France). The EpiSkin™ tissue consists of normal, human-derived epidermal keratinocytes which have been cultured to form a multilayered, highly differentiated model of the human epidermis. It consists of organized basal, spinous and granular layers, and a multi-layered stratum corneum containing intercellular lamellar lipid layers arranged in patterns analogous to those found in vivo. The EpiSkin™ tissues (surface 0.38 cm²) are cultured on specially prepared cell culture inserts.

TREATMENT:
Negative control: Deionised water (Lot no.22.12.09) was used as the negative control. 15 µL were applied to each of triplicate tissues for 15 ± 1 minutes.
Positive Control: 5% SLS (Sodium lauryl sulphate, lot no. 1353471 51508322 (Sigma, 82024 Taufkirchen, Germany) solution in deionised water, prepared freshly prior to the performance of the experiment, was used as positive control. 15 µL were applied to each of triplicate tissues for 15 ± 1 minutes.
Test item: 15 mg of the test item were applied to each of triplicate tissues (≙ 39.47 mg/cm2).
The negative and positive control, and the test item were added into the insert atop the concerning EpiSkin™ triplicate tissues. The 12-well plates were placed into the incubator for 15 ± 1 min at 37 ± 1.5 °C, 5 ± 0.5% CO2.
After the end of the treatment interval the inserts were removed immediately from the 12-well plate. Using a wash bottle the tissues were gently rinsed with PBS to remove any residual test material. Excess PBS was removed by gently shaking the inserts and blotting the bottom with blotting paper. The inserts were placed in the plates with 2 mL maintenance medium. The tissues were incubated for 42 ± 1 hour at 37 ± 1.5 °C, 5 ± 0.5% CO2.

CELL VIABILITY TEST:
Cell viability is measured by dehydrogenase conversion of MTT [(3-4,5-dimethyl thiazole 2-yl) 2,5-diphenyl-tetrazoliumbromide], present in cell mitochondria, into a blue formazan salt that is quantitatively measured after extraction from tissues (Faller, C., Bracher, M., Dami, N., Roguet, R., (2002). Predictive ability of reconstructed human epidermis equivalents for assessment of skin irritation of cosmetics. Toxicology in vitro 16 (5), 557-552). The percent reduction of cell viability in comparison of untreated negative controls is used to predict skin irritation potential.
After the treatment procedure was completed for all tissues of each time point cell culture inserts were transferred from the holding plates to plates containing 2 mL assay medium containing 0.3 mg/mL MTT per well. . After a 3 hour incubation period (37 ± 1.5 °C, 5 ± 0.5% CO2) MTT solution was aspirated from the wells and the wells were rinsed three times with PBS. Tissue samples were cut out of the inserts with a biopsy punch and transferred into plastic vials. The tissue samples were immersed into extractant solution by gently pipetting 0.5 mL extractant solution (isopropanol) into each vial. The tissue samples were completely covered by isopropanol. The vials were sealed to inhibit isopropanol evaporation. The formazan salt was extracted for 4 hours while shaking (~120 rpm) at room temperature.
Per each tissue sample 2 x 200 µL aliquots of the formazan blue solution were transferred into a 96-well flat bottom microtiter plate. OD was read in a microplate reader (Versamax® Molecular Devices, 85737 Ismaning, Germany) at 570 nm without reference filter. Mean values were calculated from the 2 wells per tissue sample.

EVALUATION OF RESULTS
The mean OD of the three negative control tissues was calculated. This value corresponds to 100% tissue viability in the current test. For each individual tissue treated with the test item or the positive control the individual relative tissue viability is calculated according to the following formula:
Relative viability (%) = (OD test item/OD negative control)*100.
For the test item and the positive control the mean relative viability ± standard deviation of the three individual tissues are calculated and used for classification according to the following prediction model:
For the current test, an irritation potential of a test item according to EU classification (acc. to Directive 67/548/EEC and Regulation 1272/2008/EC) is predicted if the mean relative tissue viability of three individual tissues is reduced below 50% of the negative control.

ACCEPTABILITY OF THE ASSAY:
The absolute OD 570 nm of the negative control tissues in the MTT test is an indicator of tissue viability obtained after the shipping and storing procedure and under specific conditions of the assay. Tissue viability is meeting the acceptance criterion if the mean OD of the three tissues is >= 0.8.
An assay is meeting the acceptance criterion if mean relative tissue viability of the positive control is <= 40%.

TEST FOR DIRECT MMT REDUCTION:
For correct interpretation of results it was necessary to assess the ability of the test item to directly reduce MTT. To test for this ability approximately 15 mg of the test item were added to 1 mL of MTT solution and the mixture was incubated in the dark at room temperature for 60 minutes. Untreated MTT medium was used as control. If the MTT solution colour turned blue/purple, the test item was presumed to have reduced the MTT. A colour change could not be observed.

No further information on the study design was stated.
Irritation / corrosion parameter:
other:
Value:
78.6
Remarks on result:
other:
Remarks:
Basis: mean. Time point: after 15 min incubation. Reversibility: no data. Remarks: After treatment with the test item the relative absorbance values were irrelevantly decreased to 78.6%. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.
Other effects / acceptance of results:
After treatment with the test item Zinc selenite the relative absorbance values were irrelevantly decreased to 78.6%. This value is well above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential.

Results after treatment with Zinc selenite

Dose group

Treatment Interval

Absorbance 570 nm
Tissue 1*

Absorbance 570 nm
Tissue 2*

Absorbance 570 nm
Tissue 3*

Mean Absorbance of 3 Tissues

Standard Deviation in %

Rel. Absorbance

[% of Negative Control]**

Negative Control

15 min

0.965

1.051

1.115

1.044

7.2

100.0

Positive Control

15 min

0.337

0.259

0.193

0.263

16.1

25.2

Zinc selenite

15 min

0.750

0.699

1.011

0.820

6.9

78.6

*       Mean of three replicate wells after blank correction
**
      relative absorbance [rounded values]: (100xabsorbance-test item)/absorbance-negative control

Optical evaluation of the MTT-reducing capacity of the test item after 1 hour incubation with MTT-reagent did not show blue colour.

Historical data:

Positive control

Negative control

Number of Studies

73

Number of Studies

73

Period

July 2007 –

March 2010

Period

July 2007 –

March 2010

Mean Viability

16.5%

Mean OD

1.081

Standard Deviation

11.0%

Standard Deviation

0.262

Range of Viabilities

3% - 36%

Range of ODs

0.7 – 1.6

Interpretation of results:
GHS criteria not met
Conclusions:
After treatment with the test item Zinc selenite the relative absorbance values were irrelevantly decreased to 78.6%. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential. The test item should not be classified and labelled as skin irritant according to regulation (EC) No. 1272/2008 and subsequent regulations.
Endpoint:
skin irritation / corrosion, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
3 studies available for read-across
Adequacy of study:
weight of evidence
Justification for type of information:
In accordance with Regulation (EC) 1907/2006 Annex XI (1.5) and the relevant ECHA guidance documents, the substances detailed in the table below are grouped for the purposes of read across to reduce the need for unnecessary repeat testing on the basis that the substances are similar on the basis of a common functional groups.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Irritation / corrosion parameter:
other: % viability
Value:
77
Remarks on result:
other: Basis: mean. Time poin: 4h.
Remarks:
Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation / corrosion parameter:
other: relative viability (%)
Value:
78.6
Remarks on result:
other:
Remarks:
Basis: mean. Time point: after 15 min incubation. Reversibility: no data. Remarks: After treatment with the test item the relative absorbance values were irrelevantly decreased to 78.6%. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential. Substance - Zinc selenite CAS: 13597-46-1 / EC: 237-048-9)
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
other: 1h
Score:
1.33
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
24 h
Score:
0.33
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
48 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0.33
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
other: 1 h
Score:
1
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
24 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
48 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Interpretation of results:
GHS criteria not met
Conclusions:
The read across for Cadmium selenide (CAS: 1306-24-7 / EC: 215-148-3); is based upon the analogous substances to which basic form, degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of skin irritation/corrosion. Based on the information available for the read across substances, the substance is not expected to be irritating or corrosive to skin.
Endpoint:
skin 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.
Qualifier:
according to
Guideline:
other: OECD Guideline 431 (In Vitro Skin Corrosion: Human Skin Model Test)
GLP compliance:
yes (incl. certificate)
Species:
other: in vitro in human skin model (EPISKIN - Standard Model™ )
Strain:
other: not applicable
Details on test animals and environmental conditions:
not applicable
Type of coverage:
other: not applicable
Preparation of test site:
other: not applicable
Vehicle:
unchanged (no vehicle)
Controls:
other: not applicable
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 20mg
Duration of treatment / exposure:
4 hours
Observation period:
not applicable
Number of animals:
not applicable
Details on study design:
TEST SITE
The assay medium was pre-warmed to 37°C. The appropriate number of an assay plate wells were filled with the pre-warmed medium (2.2 mL per well). The epidermis units were placed with the media below them, in contact with the epidermis into each prepared well. Three skin units were used for each test or control material.

-20 mg of test item was applied evenly to the epidermal surface of each of the three living and killed test skin units, then 100 µl NaCI (9 g/L saline) (same batch as used for negative control) was added to the test item to ensure good contact with the epidermis. One additional chemical-treated tissue was used for the non specific OD evaluation .
-20 mg of test item was applied evenly to the epidermal surface of the one additional chemical-treated tissue used for the non specific OD evaluation.
-50 µl NaCI (9 g/l saline) was added to each of the three negative control live and killed skin units.
-50 µl glacial acetic acid was added to each of the three positive control skin units.

The plates with the treated epidermis units were incubated for the exposure time of 4 hours at room temperature (18-28°C) covered with the plate lids.


REMOVAL OF TEST SUBSTANCE
- Washing (if done): each skin unit was removed and rinsed thoroughly with PBS 1x solution (0.9 %) to remove all of the test material from the epidermal surface.
- Time after start of exposure: after 4h

SCORING SYSTEM: corrosive chemicals show cytotoxic effects following short-term exposure of the stratum corneum of the epidermis. Cytotoxicity is expressed as the reduction of mitochondrial dehydrogenase activity measured by formazan production from MTT
Irritation / corrosion parameter:
other:
Value:
77
Remarks on result:
other:
Remarks:
Basis: mean. Time point: 4h. (migrated information)

The results of the optical density (OD) measured at 540 nm of each extract and the calculated % viability of the cells is presented below:

 

Substance

Optical Density (OD)

 OD after adjustment*

Viability (%)

Negative Control:

NaCl (9g/L saline)

 

1

0.099

 

100

2

0.090

3

0.133

mean

0.107

 

Positive Control:

Glacial acetic acid

 

1

0.000

 

0

2

0.002

 

2

3

0.017

 

16

mean

0.006

 

6

Test Item:

Cadmium telluride (CdTe)

 

1

0.092

0.086

80

2

0.084

0.078

73

3

0.091

0.085

79

mean

0.089

0.083

77

* For the test item, the material interfered with MTT which was expected to cause an OD of 0.006 in the final solutions. This was subtracted from the measured OD values.

 

 

Interpretation of results:
GHS criteria not met
Conclusions:
In this in vitro EPISKIN model test with Cadmium telluride (CdTe), the results indicate that the test item is not a skin corrosive.
Executive summary:

Disks of EPISKIN (three units / chemical) were treated with test item Cadmium telluride (CdTe) and incubated for 4 hours at room temperature. Exposure of test material was terminated by rinsing with PBS 1x solution (0.9 %). The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution. The formazan precipitated was then extracted using acidified isopropanol and quantified spectrophotometrically. NaCI (9 g/l saline) and glacial acetic acid treated epidermis were used as negative and positive controls respectively. For each treated tissue viability was expressed as a % relative to negative control.

The test substance is considered to be corrosive to skin, if the mean relative viability after 4 hours of exposure is below 35% of the negative control.

The test item did not show significantly reduced cell viability in comparison to the negative control. All test item results were far above 35% of the mean negative control value.

In this in vitro EPISKIN model test with Cadmium telluride (CdTe), the results indicate that the test item is not a skin corrosive.

Endpoint:
skin irritation: in 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.
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals and environmental conditions:
TEST ANIMALS
- Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: ~12 weeks old
- Weight at study initiation: 3075-3323 g
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages (65x65 cm with height of 45 cm). Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages.
- Diet: Animals received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi út, Hungary, ad libitum
- Water: municipal tap water, as for human consumption, ad libitum, from an automatic system.
- Acclimation period: 12 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.1-19.0 °C
- Humidity (%): 24-60%
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 0.5g
Duration of treatment / exposure:
4 hours
Observation period:
72h
Number of animals:
3
Details on study design:
TEST SITE
- Area of exposure: approximately 6 cm² area of intact skin

REMOVAL OF TEST SUBSTANCE
- Washing: the remaining test item was removed with water at body temperature
- Time after start of exposure: After 4 hours

SCORING SYSTEM:

The dermal irritation scores were evaluated according to the scoring system by Draize (1959)

SCORING SYSTEM OF ERYTHEMA AND OEDEMA FORMATION

Erythema and eschar formation

No erythema 0
Very slight erythema (barely perceptible) 1
Well defined erythema 2
Moderate to severe erythema 3
Severe erythema (beet redness) to slight eschar
formation (injuries in depth) 4

Maximum possible erythema score: 4

Oedema formation

No oedema 0
Very slight oedema (barely perceptible) 1
Slight oedema (edges of it will be well defined
by definite raising) 2
Moderate oedema (raised appr. 1 mm) 3
Severe oedema (raised more than 1 mm and extending
beyond area of exp.) 4

Maximum possible oedema score: 4



Irritation parameter:
erythema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
other: 1h
Score:
1.33
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
24 h
Score:
0.33
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
48 h
Score:
0
Irritation parameter:
erythema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0.33
Irritation parameter:
erythema score
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
erythema score
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
other: 1h
Score:
1
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
24 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
48 h
Score:
0
Irritation parameter:
edema score
Basis:
mean
Remarks:
animals #1, #2, #3
Time point:
72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
edema score
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
primary dermal irritation index (PDII)
Basis:
mean
Time point:
24/48/72 h
Score:
0.11
Other effects:
MORTALITY : no mortality observed during the study.
BODY WEIGHTS: no effect of treatment on body weight.
CLINICAL OBSERVATION

General Daily Examination: no treatment-related clinical signs noted.

Examination of Skin-Irritancy:

At observation one hour after patch removal:
well defined erythema (score2) was noted in one animal, very slight erythema (score 1) was observed in two animals and very slight oedema (score 1) was noted in all animals. The test item was also staining on the hair and skin in all animals.

At observation 24 hours after patch removal:
very slight erythema (score 1) was observed in one animal and the test item was staining on the hair and skin in all animals.

At observation 48 and 72 hours after patch removal:
there were no observed clinical signs noted on the skin of the treated animals

As no clinical signs were observed the study was terminated after the 72 hours observation.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.33, 0.00 and 0.00 respectively.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00, 0.00 and 0.00 respectively.

The Primary Irritation Index (considering readings at 24, 48 and 72 hours after patch removal) was calculated as 0.11.

SCORING OF ERYTHEMA FORMATION

 

 

TABLE 1

 

Animal No./
Sex

Body weight (g)

1 h

24 h

48 h

72 h

at the beginning
of the study

at the end
of the study

00141/ M

3323

3380

2

1

0

0

00123/M

3120

3172

1

0

0

0

00149/M

3075

3144

1

0

0

0

TOTAL

-

-

4

1

0

0

MEAN

-

-

1.33

0.33

0

0

       

 

 

 

SCORING OF OEDEMA FORMATION

 

 

TABLE 2

 

Animal No./
Sex

Body weight (g)

1 h

24 h

48 h

72 h

at the beginning
of the study

at the end
of the study

00141/ M

3323

3380

1

0

0

0

00123/M

3120

3172

1

0

0

0

00149/M

3075

3144

1

0

0

0

TOTAL

-

-

3

0

0

0

MEAN

-

-

1

0

0

0

 

 

M   = male

d     = day

h     = hour



 

MEAN VALUES OF SKIN IRRITATION SCORES

(24, 48, 72 hours reading)

 

TABLE 3

 

 

Animal Number

Sex

Erythema

Oedema

00141

male

0.33

0.00

00123

male

0.00

0.00

00149

male

0.00

0.00

 

 


 

Interpretation of results:
GHS criteria not met
Conclusions:
According to the UN Globally Harmonised System of Classification and Labelling of Chemicals,Cadmium telluride does not require classification as a skin irritant.

 
Executive summary:

An acute skin irritation study was performed with Cadmium telluride in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritancy of the test item was evaluated according to the Draize method (OECD No.: 404, 2002).

A weight of 0.5g granules test item was applied to the skin of the experimental animals as ground to a powder. The test item was applied as a single dose. Sufficient water to damp the material was used to ensure good contact with the skin and an adhesive clear plastic patch was applied. The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place. The untreated skin of each animal served as control.

After 4 hours, the remaining test item was removed with water at body temperature.

 

To assess skin irritation, animals were examined at 1, 24, 48 and 72 hours after the patch removal. Additional general examinations were performed daily.

There was no mortality or systemic clinical changes related to Cadmium telluride administration.

There was no effect of treatment on body weight.

 

At observation one hour after patch removal,well defined erythema (score2) was noted in one animal, very slight erythema (score 1) was observed in two animals and very slight oedema (score 1) was noted in all animals.The test item was also staining on the hair and skin in all animals.

 

At observation 24 hours after patch removal,very slight erythema (score 1) was observed in one animal and the test item was staining on the hair and skin in all animals.

 

At observation 48 and 72 hours after patch removal,there were no observed clinical signs noted on the skin of the treated animals

 

As no clinical signs were observed the study was terminated after the 72 hours observation.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.33, 0.00 and 0.00 respectively.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00, 0.00 and 0.00 respectively.

 

The Primary Irritation Index (considering readings at 24, 48 and 72 hours after patch removal) was calculated as 0.11.

 

According to Directive 2001/59/EC,Cadmium telluride does not require classification as a skin irritant.

 

According to the UN Globally Harmonised System of Classification and Labelling of Chemicals,Cadmium telluride does not require classification as a skin irritant.

 

According to the classification system based on the scheme devised by Draize (1959),Cadmium telluride is a "mild irritant".

Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Eye irritation

Link to relevant study records

Referenceopen allclose all

Endpoint:
eye irritation, other
Type of information:
read-across from supporting substance (structural analogue or surrogate)
Remarks:
3 studies available for read-across
Adequacy of study:
weight of evidence
Justification for type of information:
In accordance with Regulation (EC) 1907/2006 Annex XI (1.5) and the relevant ECHA guidance documents, the substances detailed in the table below are grouped for the purposes of read across to reduce the need for unnecessary repeat testing on the basis that the substances are similar on the basis of a common functional groups.
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Reason / purpose:
read-across source
Irritation parameter:
other: corneal thickness (%)
Run / experiment:
minat up to
Value:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
other: corneal thickness (%)
Run / experiment:
at up to 240 min
Value:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
cornea opacity score
Run / experiment:
mean maximum
Value:
0.67
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
fluorescein retention score
Run / experiment:
mean
Value:
1.83
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
other: discharge
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
other: discharge
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
other: discharge
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Remarks on result:
other: Telluroxocadmium (CAS: 1306-25-8 / EC: 215-149-9)
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Zinc selenite (CAS: 13597-46-1 / EC: 237-048-9)
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Zinc selenite (CAS: 13597-46-1 / EC: 237-048-9)
Irritation parameter:
conjunctivae score
Basis:
mean
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Zinc selenite (CAS: 13597-46-1 / EC: 237-048-9)
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Zinc selenite (CAS: 13597-46-1 / EC: 237-048-9)
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Zinc selenite (CAS: 13597-46-1 / EC: 237-048-9)
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Zinc selenite (CAS: 13597-46-1 / EC: 237-048-9)
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Zinc selenite (CAS: 13597-46-1 / EC: 237-048-9)
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Zinc selenite (CAS: 13597-46-1 / EC: 237-048-9)
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Zinc selenite (CAS: 13597-46-1 / EC: 237-048-9)
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Zinc selenite (CAS: 13597-46-1 / EC: 237-048-9)
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
other: Zinc selenite (CAS: 13597-46-1 / EC: 237-048-9)
Interpretation of results:
GHS criteria not met
Conclusions:
The read across for Cadmium selenide (CAS: 1306-24-7 / EC: 215-148-3); is based upon the analogous substances to which basic form, degree of substitution of functional groups is not considered to effect the proposed read across for the endpoint of eye damage/irritation. Based on the information available for the read across substances, the substance is not expected to be irritating or damaging to eyes.
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.
Qualifier:
according to
Guideline:
OECD Guideline 438 (Isolated Chicken Eye Test Method for Identifying Ocular Corrosives and Severe Irritants)
GLP compliance:
yes (incl. certificate)
Species:
other: in vitro in isolated chicken eyes
Strain:
other: not applicable
Details on test animals or tissues and environmental conditions:
not applicable
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

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

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)

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.

Endpoint:
eye irritation: in 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.
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)
Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: S&K-LAP Kft. 2173 Kartal, Császár út 135, HUNGARY
- Age at study initiation: ~13 weeks old
- Weight at study initiation: 3232 – 3500 g
- Housing: Rabbits were individually housed in AAALAC approved metal wire rabbit cages. Cages were of an open wire structure and cages were placed together to allow some social interaction with rabbit(s) in adjoining cages
- Diet: Animal received PURINA Base – Lap gr. diet for rabbits produced by AGRIBRANDS Europe Hungary PLC, H-5300 Karcag, Madarasi road, Hungary, ad libitum.
- Water: municipal tap water, as for human consumption, ad libitum, from an automatic system.
- Acclimation period: 20 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 17.1- 21.4°C
- Humidity (%): 24 - 60 %
- Air changes (per hr): 15-20 air exchanges/hour
- Photoperiod (hrs dark / hrs light): 12 hours daily, from 6.00 a.m. to 6.00 p.m.
Vehicle:
unchanged (no vehicle)
Controls:
not required
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied: 100mg


Duration of treatment / exposure:
1 hour
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours after treatment. The study was terminated after 72 hours observation.
Number of animals or in vitro replicates:
3
Details on study design:
REMOVAL OF TEST SUBSTANCE
- Washing (if done): eyes of the test animals were washed out
- Time after start of exposure: at 1 hour after application of test item

SCORING SYSTEM:
The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24 April 2002)

Irritation parameter:
cornea opacity score
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
cornea opacity score
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
iris score
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
chemosis score
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
other: discharge
Basis:
animal #1
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0
Irritation parameter:
other: discharge
Basis:
animal #2
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 72 hours
Irritation parameter:
other: discharge
Basis:
animal #3
Remarks:
animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal)
Time point:
24/48/72 h
Score:
0.67
Reversibility:
fully reversible within: 72 hours

MORTALITY: no mortality observed during the study.

BODY WEIGHTS: The body weight and body weight change were considered to be normal with no indication of treatment related effect

CLINICAL OBSERVATION:

General daily examination: no clinical signs observed that could be related to treatment.

Examination of eye-irritancy:

The eyes were examined at 1, 24, 48 and 72 hours after the application.

 

Initial Pain Reaction(IPR) (score 1) was observed in the animals.

One hour after the application:Conjunctival redness (score 1) and discharge (score 1 or 3) was noted in 2/3 animals.

At 24 hours after treatment:Conjunctival redness (score 1) was noted in one animal and discharge (score 1) was noted in 2/3 animals.

At 48 hours after treatment:Conjunctival redness (score 1) and discharge (score 1) was noted in one animal.

At 72 hours after treatment:There were no clinical signs, and noconjunctival orcorneal effects observed.

 

As there were no clinical signs observed, the study was terminated 72 hours after the treatment.

During the study, the control eye of each animal was symptom-free.


The general state and behavior of animals were normal throughout the study period.

 There were no notable body weight changes during the study period.

 The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

chemosis          : 0.00, 0.00, 0.00

discharge         : 0.00, 0.33, 0.67

redness             : 0.00, 0.67, 0.00

cornea opacity : 0.00, 0.00, 0.00

iris                    : 0.00, 0.00, 0.00

TABLE 1:Individual Scores for Ocular Irritation

 

Abbreviations:   R    = Redness                                OD =   Opacity degree of density

                               CH = Chemosis                              OE =   Extent of opaque area

D    = Discharge                              IPR=   Initial pain reaction

 

Time

Animal No.

Score of irritation

IPR

Conjunctivae

Opacity of cornea

Iris

Control eye

Other sign

R

CH

D

OD

OE

R

1 hour

00124

1

0

0

0

0

0

0

-

1

00182

1

0

3

0

0

0

0

-

1

00122

0

0

1

0

0

0

0

-

1

Time of Observation: Day 0

Time

Animal No.

Score of irritation

Conjunctivae

Opacity of cornea

Iris

Control eye

Other sign

R

CH

D

OD

OE

R

24 hours

00124

0

0

0

0

0

0

0

-

00182

1

0

1

0

0

0

0

-

00122

0

0

1

0

0

0

0

-

Time of Observation: Day 1

Time

Animal No.

Score of irritation

Conjunctivae

Opacity of cornea

Iris

Control eye

Other sign

R

CH

D

OD

OE

R

48 hours

00124

0

0

0

0

0

0

0

-

00182

1

0

0

0

0

0

0

-

00122

0

0

1

0

0

0

0

-

Time of Observation: Day 2

Time

Animal No.

Score of irritation

Conjunctivae

Opacity of cornea

Iris

Control eye

Other sign

R

CH

D

OD

OE

R

72 hours

00124

0

0

0

0

0

0

0

-

00182

0

0

0

0

0

0

0

-

00122

0

0

0

0

0

0

0

-

Time of Observation: Day 3

TABLE 2: MEAN VALUES OF EYE IRRITATION (24, 48, 72 hour reading)

 

 

Animal Number

Sex

Cornea Opacity

Iris

Conjunctivae

Redness

Chemosis

Discharge

00124

male

0.00

0.00

0.00

0.00

0.00

00182

male

0.00

0.00

0.67

0.00

0.33

00122

male

0.00

0.00

0.00

0.00

0.67

TABLE 3: BODY WEIGHT DATA

 

 

 

Animal Number

Beginning of study
(g)

At the end of study
(g)

Body weight gain
(g)

00124

3500

3551

51

00182

3232

3279

47

00122

3337

3380

43

 

 

 

 

Interpretation of results:
GHS criteria not met
Conclusions:
The test item Cadmium telluride, applied to rabbit eye mucosa, caused significant conjunctival irritant effects at one hour which were reduced at 24 hours after application. The effects were fully reversible within 72 hours.

According to Regulation (EC) No 1272/2008, Cadmium telluride does not require classification as an eye irritant.

Executive summary:

An acute eye irritation study of the test item Cadmium telluride was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2002).

The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. An amount of 0.1g of the test item was administered as a single dose.

 

The eyes were examined at 1, 24, 48 and 72 hours after the application.

 

Initial Pain Reaction(IPR) (score 1) was observed in the animals.

One hour after the application:Conjunctival redness (score 1) and discharge (score 1 or 3) was noted in 2/3 animals.

At 24 hours after treatment:Conjunctival redness (score 1) was noted in one animal and discharge (score 1) was noted in 2/3 animals.

At 48 hours after treatment:Conjunctival redness (score 1) and discharge (score 1) was noted in one animal.

At 72 hours after treatment:There were no clinical signs, and noconjunctival orcorneal effects observed.

 

As there were no clinical signs observed, the study was terminated 72 hours after the treatment.

During the study, the control eye of each animal was symptom-free.

The general state and behavior of animals were normal throughout the study period.

There were no notable body weight changes during the study period.

 

The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

chemosis          : 0.00, 0.00, 0.00

discharge         : 0.00, 0.33, 0.67

redness             : 0.00, 0.67, 0.00

cornea opacity : 0.00, 0.00, 0.00

iris                    : 0.00, 0.00, 0.00


 

The test item Cadmium telluride, applied to rabbit eye mucosa, caused significant conjunctival irritant effects at one hour which were reduced at 24 hours after application. The effects were fully reversible within 72 hours.

 

According toRegulation (EC) No 1272/2008,Cadmium telluride does not require classification as an eye irritant.


 

 

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2010-03-18 to 2010-03-28
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
guideline study
Reason / purpose:
reference to same study
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
, 2002-04-24
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
, 2008
Deviations:
no
GLP compliance:
yes (incl. certificate)
Remarks:
signed 2009-11-12
Species:
rabbit
Strain:
Himalayan
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: LPT Laboratory of Pharmacology and Toxicology GmbH & Co. KG, Branch Löhndorf, 24601 Löhndorf/Post Wankendorf, Germany
- Age at study initiation: approx. 7.5 - 9.5 months
- Weight at study initiation: 2.6 - 2.9 kg (at dosing)
- Housing: for 8 hours following test item application, the animals were kept singly in restrainers which allowed free movement of the head but prevented a complete body turn, wiping of the eyes with the paws and excluded irritation of the eye by excrements and urine; during acclimatisation and after the 8 hours period, the animals were kept singly in cages with dimensions of 380 mm x 425 mm x 600 mm (manufacturer: Dipl.Ing. W. EHRET GmbH, 16352 Schönwalde, Germany)
- Diet: Commercial diet, ssniff7 K-H V2333 (ssniff Spezialdiäten GmbH, 59494 Soest, Germany), ad libitum
- Water: tap water, ad libitum
- Acclimation period: at least 20 adaptation days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20°C ± 3°C (maximum range)
- Relative humidity (%): 30% - 70% (maximum range; aim was 50 % - 60 %)
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2010-03-18 To: 2010-03-28
No further information on the test animals was stated.
Vehicle:
unchanged (no vehicle)
Controls:
no
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg test item were applied in the powdered form as supplied into one eye each of the three animals. The test item was placed into the conjunctival sac of the right eye after gently pulling the lower lid away from the eyeball. The lids were then gently held together for about one second in order to prevent loss of the material. The left eye, which remained untreated, served as control.
Duration of treatment / exposure:
single instillation, 1 hour after administration the eyes were rinsed.
Observation period (in vivo):
72 hours (before dosing, 60 min, 24 hours, 48 hours and 72 hours after dosing)
Number of animals or in vitro replicates:
3 male rabbits
Details on study design:
The test was performed using one animal initially. As no corrosive or severe irritant effects were observed in this animal, 2 further animals were employed 24 hours after start of the initial test.

REMOVAL OF TEST SUBSTANCE
- Washing (if done): the eyes were rinsed with portions of 20 mL 0.9% aqueous NaCl solution, each
- Time after start of exposure: 1 hour after administration

SCORING SYSTEM: Draize scoring system

TOOL USED TO ASSESS SCORE:
- slit lamp, prior to the administration and 1, 24, 48 and 72 hours after the administration
- fluorescein, 24 hours after administration

OTHER OBSERVATIONS: Any further lesions not covered by the scoring system were recorded. Body weight of all animals was measured at the beginning of the study and at the end of the study. Behaviour and food consumption were monitored.
No further information on the study design was stated.
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritant / corrosive response data:
Conjunctival redness (grade 1: Some blood vessels hyperaemic (injected)) was observed in all animals 1 hour after instillation.
Chemosis (grade 1: Some swelling above normal) was observed in one animal 1 hour after instillation.
In addition, secretion was observed in all animals 1 hour after instillation.
The corneae and the irises were not affected by instillation of the test item.
The fluorescein test performed 24 hours after instillation did not reveal any changes.
Other effects:
There were no systemic intolerance reactions.
Interpretation of results:
GHS criteria not met
Conclusions:
According to the test result zinc selenite is not irritating to eyes. According to the criteria specified in Regulation (EC) No 1272/2008 and subsequent regulations, the test item is non-irritating and does not require classification.
Endpoint conclusion
Endpoint conclusion:
no adverse effect observed (not irritating)

Respiratory irritation

Endpoint conclusion
Endpoint conclusion:
no study available

Additional information

Skin Corrosion/Irritation

An acute skin irritation study was performed with Cadmium telluride in New Zealand White rabbits. Parameters monitored during this study included mortality, body weight measurements and clinical observations. The irritancy of the test item was evaluated according to the Draize method (OECD No.: 404, 2002).

A weight of 0.5g granules test item was applied to the skin of the experimental animals as ground to a powder. The test item was applied as a single dose. Sufficient water to damp the material was used to ensure good contact with the skin and an adhesive clear plastic patch was applied. The trunk was wrapped in clear plastic with medical tubing used to hold the patch in place. The untreated skin of each animal served as control.

After 4 hours, the remaining test item was removed with water at body temperature.

To assess skin irritation, animals were examined at 1, 24, 48 and 72 hours after the patch removal. Additional general examinations were performed daily.

There was no mortality or systemic clinical changes related to Cadmium telluride administration.

There was no effect of treatment on body weight.

At observation one hour after patch removal, well defined erythema (score2) was noted in one animal, very slight erythema (score 1) was observed in two animals and very slight oedema (score 1) was noted in all animals. The test item was also staining on the hair and skin in all animals.

At observation 24 hours after patch removal, very slight erythema (score 1) was observed in one animal and the test item was staining on the hair and skin in all animals.

At observation 48 and 72 hours after patch removal, there were no observed clinical signs noted on the skin of the treated animals.

As no clinical signs were observed the study was terminated after the 72 hours observation.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for erythema were 0.33, 0.00 and 0.00 respectively.

The animals’ individual mean scores (considering readings at 24, 48 and 72 hours after patch removal) for oedema were 0.00, 0.00 and 0.00 respectively.

The Primary Irritation Index (considering readings at 24, 48 and 72 hours after patch removal) was calculated as 0.11.

According to Directive 2001/59/EC, Cadmium telluride does not require classification as a skin irritant.

According to the UN Globally Harmonised System of Classification and Labelling of Chemicals, Cadmium telluride does not require classification as a skin irritant.

According to the classification system based on the scheme devised by Draize (1959), Cadmium telluride is a "mild irritant".

 

Disks of EPISKIN (three units / chemical) were treated with test item Cadmium telluride (CdTe) and incubated for 4 hours at room temperature. Exposure of test material was terminated by rinsing with PBS 1x solution (0.9 %). The viability of each disk was assessed by incubating the tissues for 3 hours with MTT solution. The formazan precipitated was then extracted using acidified isopropanol and quantified spectrophotometrically. NaCI (9 g/l saline) and glacial acetic acid treated epidermis were used as negative and positive controls respectively. For each treated tissue viability was expressed as a % relative to negative control.

The test substance is considered to be corrosive to skin, if the mean relative viability after 4 hours of exposure is below 35% of the negative control.

The test item did not show significantly reduced cell viability in comparison to the negative control. All test item results were far above 35% of the mean negative control value.

In this in vitro EPISKIN model test with Cadmium telluride (CdTe), the results indicate that the test item is not a skin corrosive.

 

After treatment with the test item Zinc selenite the relative absorbance values were irrelevantly decreased to 78.6%. This value is above the threshold for irritancy of ≤ 50%. Therefore, the test item is not considered to possess an irritant potential. The test item should not be classified and labelled as skin irritant according to regulation (EC) No. 1272/2008 and subsequent regulations.

 

Eye Damage/Irritation

An acute eye irritation study of the test item Cadmium telluride was performed in New Zealand White rabbits. The irritation effects of the test item were evaluated according to the Draize method (OECD No.: 405, 2002).

The test item was placed into the conjunctival sac of the left eye of each animal. The untreated right eye served as control. An amount of 0.1g of the test item was administered as a single dose.

The eyes were examined at 1, 24, 48 and 72 hours after the application.

Initial Pain Reaction (IPR) (score 1) was observed in the animals.

One hour after the application: Conjunctival redness (score 1) and discharge (score 1 or 3) was noted in 2/3 animals.

At 24 hours after treatment: Conjunctival redness (score 1) was noted in one animal and discharge (score 1) was noted in 2/3 animals.

At 48 hours after treatment: Conjunctival redness (score 1) and discharge (score 1) was noted in one animal.

At 72 hours after treatment: There were no clinical signs, and no conjunctival or corneal effects observed.

As there were no clinical signs observed, the study was terminated 72 hours after the treatment.

During the study, the control eye of each animal was symptom-free.

The general state and behavior of animals were normal throughout the study period.

There were no notable body weight changes during the study period.

The animal’s individual mean scores (considering readings at 24, 48 and 72 hours after the treatment) were as follows:

chemosis          : 0.00, 0.00, 0.00

discharge         : 0.00, 0.33, 0.67

redness             : 0.00, 0.67, 0.00

cornea opacity : 0.00, 0.00, 0.00

iris                    : 0.00, 0.00, 0.00

The test item Cadmium telluride, applied to rabbit eye mucosa, caused significant conjunctival irritant effects at one hour which were reduced at 24 hours after application. The effects were fully reversible within 72 hours.

According to Regulation (EC) No 1272/2008, Cadmium telluride does not require classification as an eye irritant.

 

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.

Justification for classification or non-classification

Based on the information available from the read-across substances, cadmium selenide does not meet the classification criteria for skin and eye irritation or corrosion according to Regulation (EC) 1272/2008.