Registration Dossier

Toxicological information

Eye irritation

Currently viewing:

Administrative data

Endpoint:
eye irritation: in vivo
Type of information:
experimental study
Adequacy of study:
key study
Study period:
2012-10-09 to 2012-10-16
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
other: GLP and guideline compliant study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2013
Report Date:
2013

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Version / remarks:
(2002)
Deviations:
no
Qualifier:
according to
Guideline:
EU Method B.5 (Acute Toxicity: Eye Irritation / Corrosion)
Version / remarks:
(2008)
Deviations:
no
Qualifier:
according to
Guideline:
EPA OPPTS 870.2400 (Acute Eye Irritation)
Version / remarks:
(1998)
Deviations:
no
GLP compliance:
yes (incl. certificate)

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
other: solid

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: Young adult rabbits
- Weight at study initiation: 2870-2925 g
- Housing: Animals were housed individually in metal cages.
- Diet: Fattening mixed diet, ad libitum
- Water: Tap water, ad libitum
- Acclimation period: 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 20 ± 3 °C
- Humidity (%): 30 - 70 %
- Air changes (per hr): 9-12 changes/hour
- Photoperiod: Artificial light, from 6 a.m. to 6 p.m.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
other: contralateral eye
Amount / concentration applied:
TEST MATERIAL
- Amount applied: 0. 1 g
Duration of treatment / exposure:
In the first step an initial test was performed using one animal. The test item was firstly well grinded and was poured into the conjunctival sac of the left eye. The eyelids were held closed gently for several seconds to prevent the loss of the test item. The contralateral eye served as control. Immediately after the administration of the test item, an assessment of the initial pain reaction was made according to the six point scale.
After consideration of the ocular responses produced in the first animal, two additional animals were treated.
Before the administration, the eyes of the second and the third animal were not anaesthetised, because the score of initial pain reaction was 2 in the first animal. The eyes of the test animals were not washed out after the application of test item.
Observation period (in vivo):
The eyes were examined at 1, 24, 48 and 72 hours after the application.
Number of animals or in vitro replicates:
3 animals
Details on study design:
REMOVAL OF TEST SUBSTANCE
None
SCORING SYSTEM: The eye irritation scores were evaluated according to the scoring system by Draize (1977) and OECD 405 (24th April 2002).

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48, 72 h
Score:
0.33
Max. score:
4
Reversibility:
fully reversible within: 24 h
Remarks on result:
other: The max score gives the theoretically highest reachable score.
Irritation parameter:
iris score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24, 48, 72 h
Score:
0
Max. score:
2
Remarks on result:
other: The max score gives the theoretically highest reachable score.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24h
Score:
2
Max. score:
3
Remarks on result:
other: The max score gives the theoretically highest reachable score.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 48 h
Score:
0.33
Max. score:
3
Remarks on result:
other: The max score gives the theoretically highest reachable score.
Irritation parameter:
conjunctivae score
Remarks:
redness
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 72 h
Score:
1
Max. score:
3
Remarks on result:
other: The max score gives the theoretically highest reachable score.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24 h
Score:
1.33
Max. score:
4
Remarks on result:
other: The max score gives the theoretically highest reachable score.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 48 h
Score:
0
Max. score:
4
Remarks on result:
other: The max score gives the theoretically highest reachable score.
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 72 h
Score:
0.33
Max. score:
4
Remarks on result:
other: The max score gives the theoretically highest reachable score.
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 24 h
Score:
2
Max. score:
3
Remarks on result:
other: The max score gives the theoretically highest reachable score.
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 48 h
Score:
0.33
Max. score:
3
Remarks on result:
other: The max score gives the theoretically highest reachable score.
Irritation parameter:
conjunctivae score
Remarks:
discharge
Basis:
mean
Remarks:
of 3 animals
Time point:
other: 72 h
Score:
1.33
Max. score:
3
Remarks on result:
other: The max score gives the theoretically highest reachable score.

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: EU
Conclusions:
In conclusion, test item cesium iodide applied to the rabbits' eye mucosa, caused slight to severe conjunctival and slight corneal irritant effects, fully reversible within 1 week.
According to the Commission Directive 2001/59/EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.
According to Regulation (EC) No. 1272/2008, the test item has not been classified into any category.
Executive summary:

The eyes were examined at 1, 24, 48 and 72 hours then 1 week after the application. One hour after treatment, some hyperemic blood vessels (score 1) were observed in all animals. The obvious swelling with partial eversion of lids (score 2) was detected in animal No.: 1742 and the swelling was different from normal (score 1) in two animals (No.: 1735, 1732). The discharge with moistening of the lids and hairs just adjacent to lids (score 2) were observed in two animals (No.: 1742, 1735) and the discharge moistened lids and hairs on considerable area around the treated eye (score 3) was recorded in animal No.: 1732. Diffuse areas of opacity were detected and the details of iris were clearly visible (score 1) in two animals (No.: 1742, 1732). Area of cornea involved was greater than one quarter, but less than half (score 2) in both animals. 24 hours after treatment, some hyperemic blood vessels (score 1) were observed in two animals (No.: 1735, 1732) and diffuse, crimson coloured conjunctivae with not easily discernible individual vessels (score 2) occurred in animal No.: 1742. The obvious swelling with partial eversion of lids (score 2) was detected in animal No.: 1742 and the swelling was different from normal (score 1) in animal (No.: 1732). The discharge with moistening of the lids and hairs just adjacent to lids (score 2) were observed in two animals (No.: 1742, 1732) and the amount of the discharge was different from normal (score 1) in animal No.: 1735. Diffuse areas of opacity were detected and the details of iris were clearly visible (score 1) in animal No.: 1742. Area of cornea involved was at least one quarter, but not zero (score 1) in this animal. 48 hours after treatment, some hyperemic blood vessels (score 1) were observed in animal No.: 1732 and diffuse, crimson coloured conjunctivae with not easily discernible individual vessels (score 2) occurred in animal No.: 1742. The swelling was different from normal (score 1) in animal (No.: 1742). The discharge with moistening of the lids and hairs just adjacent to lids (score 2) were observed in animal No.: 1742 and the amount of the discharge was different from normal (score 1) in animal No.: 1732. 72 hours after the treatment, the state of animals was unchanged. 1 week after the treatment the study was terminated, since no primary irritation symptoms occurred. During the study the control eyes of the animals were symptom-free. General state and the behaviour of the animals were normal throughout the study period. There were no effects on body weight attributable to the treatment with the test item during the contact and observation period.

In conclusion, test item cesium iodide applied to the rabbits' eye mucosa, caused slight to severe conjunctival and slight corneal irritant effects, fully reversible within 1 week.

According to the Commission Directive 2001/59/EC criteria for classification and labelling requirements for dangerous substances and preparations, the test item does not have to be classified and has no obligatory labelling requirement for eye irritation.

According to Regulation (EC) No. 1272/2008, the test item has not been classified into any category.