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Toxicological information

Skin irritation / corrosion

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Administrative data

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:
guideline study

Data source

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

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 404 (Acute Dermal Irritation / Corrosion)
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)

The pH of Test Item was measured as 5.0.

Test animals

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.

Test system

Type of coverage:
semiocclusive
Preparation of test site:
shaved
Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
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



Results and discussion

In vivo

Resultsopen allclose all
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.

Any other information on results incl. tables

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

 

 


 

Applicant's summary and conclusion

Interpretation of results:
not classified
Remarks:
Migrated information Criteria used for interpretation of results: EU
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".