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Toxicological information

Eye irritation

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Administrative data

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:
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 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Details on test material:
Product name: cadmium telluride
Molecular Formula: CdTe
Batch number: 163568
CAS number: 1306-25-8
Appearance: Black solid
Purity: > 99.99%
Expiry date: 2 years from the first opening (05 November 2011) if kept under inert atmosphere (e.g. nitrogen)
Storage conditions: 20 ±5ºC under inert gas (e.g. nitrogen).
Safety Precautions: Routine safety precautions (gloves, goggles, face mask, lab coat) for unknown materials were applied to assure personnel health and safety.

Test animals / tissue source

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.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
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)

Results and discussion

In vivo

Resultsopen allclose all
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
Max. score:
4
Remarks on result:
no indication of irritation
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
Max. score:
4
Remarks on result:
no indication of irritation
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
Max. score:
4
Remarks on result:
no indication of irritation
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
Max. score:
2
Remarks on result:
no indication of irritation
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
Max. score:
2
Remarks on result:
no indication of irritation
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
Max. score:
2
Remarks on result:
no indication of irritation
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
Max. score:
3
Remarks on result:
no indication of irritation
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
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
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
Max. score:
3
Remarks on result:
no indication of irritation
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
Max. score:
4
Remarks on result:
no indication of irritation
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
Max. score:
4
Remarks on result:
no indication of irritation
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
Max. score:
4
Remarks on result:
no indication of irritation
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
Max. score:
3
Remarks on result:
no indication of irritation
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
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation
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
Max. score:
3
Reversibility:
fully reversible within: 72 hours
Remarks on result:
no indication of irritation

Any other information on results incl. tables

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

 

 

 

 

Applicant's summary and conclusion

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