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Diss Factsheets

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
Study period:
11th June 2018 to 7th January 2019
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2019
Report date:
2019

Materials and methods

Test guideline
Qualifier:
according to guideline
Guideline:
other: Acute Eye Irritation / Corrosion (405) published by the Ministry of Environmental Protection of Peoples Republic of China in the year 2013
GLP compliance:
yes

Test material

Test animals / tissue source

Species:
rabbit
Strain:
other: Japanese White
Details on test animals or tissues and environmental conditions:
Source: Qingdao Kangda Biological technology Limited company
A physical check up was carried out on all animals on arrival. Animals were acclimatised for 11 days and housed individually in Room A115. All animals were weighed and marked on the hair. Clinical observations were performed daily. Animals were raised in suspended stainless steel cages.
Temperature: 17 - 23oC
Humidity: 40-70%
Light sequence: 12 hour light / 12 hour dark
Food: Rabbit Maintenance Feed (Beijing keaoxieli Feed Co. Ltd.)
Water: ad libitum
To avoid or minimise pain and distress in ocular safety testing procedures, a local anaesthetic tetracaine hydrochloride 0.5% 1 drop per eye was used 5 minutes prior to test substance application

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
0.1g test item
Duration of treatment / exposure:
72 hours
Observation period (in vivo):
Observations made 1, 24, 48 and 72 hours after treatment.
Number of animals or in vitro replicates:
3
Details on study design:
To investigate if the test material has eye-irritation potential, a sequenced in vivo test in rabbits was conducted.
The test was performed initially using one animal.
The corrosive or severe irritant effect was not observed in the initial test. A confirmatory test was conducted by exposing two additional animals simultaneously at the 24 hours observation point for the initial animal.

Eye Examination before Testing
Approximately 24 hours prior to dosing, both eyes of each animal were examined with a binocular loupe and 2% aqueous sodium fluorescein in the slit lamp. One drop of 2% aqueous sodium fluorescein was placed in the conjunctivae sac of both eyes. After 15 seconds, the eyes were washed using physiological saline. Corneas of both eyes were examined in the slit lamp to see whether there was flourescein detention in the cornea. No eye abnormalities were noted for all treated eyes prior to the test.

Administration Method
0.1g of test item was placed in the conjunctival sac of the right eye of each animal after gently pulling the lower lid away from the eyeball. The lids were gently held together for approximately one second in order to prevent loss of the material. The left eye remained untreated and served as a control.

Observation
Immediately after administration of the test item, the initial reaction was observed and recorded. Animals were observed twice daily for clinical signs and any adverse systemic effects after administration of test item. All treated eyes were examined at approximately 1, 24, 48 and 72 hours after administration. Because all animals had slight irritation, reactions were recorded 24 hours after administration and further observation was made 72 hours after administration. Both eyes of each animal were further examined with the aid of fluorescein sodium and slit lamp. Fluorescein stain was used to aid in scoring at the 24, 48 and 72 hours observation point.

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.3
Max. score:
1
Reversibility:
fully reversible within: 48 hours
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0
Max. score:
0
Remarks on result:
no indication of irritation

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
Based on the results in the Japanese White Rabbit, E Stage 3 Intermediate could produce reversible eye irritant reactions and was classified as 'unclassified' according to GHS classification criteria for eye irritation
Executive summary:

The study was performed to assess the acute eye irritation/corrosion of E Stage 3 Intermediate in Japanese White rabbits. The method was designed to be in accordance with the guidelines for the testing of chemicals 'Acute Eye Irritation/Corrosion' (405) published by the Ministry of Environmental Protection of People's Republic of China in the year 2013. 


Three male rabbits were used for the study. Each animal was administered 0.1g of the test item in the right eye. The untreated left eye served as the control. The rabbits were observed and recorded for initial reaction immediately, 1, 24, 48 and 72 hours after administration. Mean scores of ocular lesions at approximately 24, 48 and 72 hours after administration were calculated for treated eyes. Individual animal body weights were recorded during the study.


During the initial test, one animal showed iris congestion, swelling, moderate circum corneal hyperaemia, conjunctivae redness and swelling at 1 hour and recovered at 48 hours after administration. During the confirmatory test, the two animals showed conjunctivae redness at approximately 1 hour and recovered at 24 hours after administration. The mean scores of iris and conjunctivae redness were both 0.3.  No abnormal clinical signs were observed and all animals showed expected gain in bodyweight during the study. 


Based on the results in the Japanese White Rabbit, E Stage 3 Intermediate could produce reversible eye irritant reactions and was classified as 'unclassified' according to GHS classification criteria for eye irritation.