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
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2018

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
Type:
Constituent
Test material form:
liquid

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
1. Select reason test system
NZW rabbit is commonly used for this type of acute eye irritation and corrosion study for several decades and accumulated enough raw data to be compared and easy to be interpreted of experimental results.
2. Quarantine and Acclimation
The animals were examined for quarantine on the receipt and acclimatized to the Centralbio Animal Breeding Room for 5 days. Four healthy animals were selected and used for the study based on general health conditions.
3. Animal and cage identification
The animals was marked in the ear pinna using a permanent marker and identification cards was attached to each cage for an individual discrimination.

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0
Reversibility:
not fully reversible within: 21 days
Remarks on result:
positive indication of irritation
Remarks:
it indicated after 72 hours.
Irritation parameter:
cornea opacity score
Basis:
animal #2
Time point:
24/48/72 h
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
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal #1
Time point:
24/48/72 h
Score:
1
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #3
Time point:
24/48/72 h
Score:
1
Reversibility:
not fully reversible within: 72 h
Irritation parameter:
iris score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.7
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2.3
Reversibility:
not fully reversible within: 20 d
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2.3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2.3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2.3
Reversibility:
not fully reversible within: 8 d
Irritation parameter:
chemosis score
Basis:
animal #1
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 15 d
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 6 d
Irritation parameter:
chemosis score
Basis:
animal #3
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 6 d
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
2
Reversibility:
not fully reversible within: 6 d
Irritant / corrosive response data:
After 3 minutes of the initial test administration, no significant eye injury was observed as a result of observing the test substance administration site. Therefore, three additional animals were used for the confirmation test. As a result of observing the test substance administration sites at 1, 24, 48 and 72 hours after the test substance administration in the initial test and confirmation test, iris hyperemia was observed as 1 point in all cases at form 24 hours to 48 hours, 1 case was recovered at 72 hours and observed as 1 point in 3 cases. Observed iris hyperemia was recovered in 2 cases on the day 4 and 1 case on the day 16. Conjunctival redness was observed as 2 points in 2 cases at 1 hour and as 3 point in all cases at 24 hours, as 2 points in all cases at from 48 hours to 72 hours. Observed conjunctival redness was recovered as 3 cases on the day 9 and as 1 case on the day 21. Conjunctival swelling was observed as 2 points in all cases at from 1 hour to 72 hours. Observed conjunctival swelling was recovered as 3 cases on the day 7 and as 1 case on the day 16. Lacrima was observed as 2 points in all cases at from 1 hour to 24 hours and as 1 point in all cases at from 48 hours to 72 hours. Observed Lacrima was recovered as all cases on the day 6. In addition, corneal opacity was observed in 1 cases on day 4 and was not recovered until 21 days. No specific symptoms were observed in the cornea, iris, and conjunctiva in the left eye.
Other effects:
1. Mortality and Clinical Signs
No clinical sign and mortality was observed relating to test substance treatment.
2. Body Weights
All the animals showed normal gains in body weights during the study period.

Applicant's summary and conclusion

Interpretation of results:
Category 1 (irreversible effects on the eye) based on GHS criteria
Conclusions:
As a result, eye irritation and corrosion test of eye of female NewZealand White rabbits of 1,2,3-tris(2,3-epoxypropoxy)propane under the test conditions showed that the turbidity of the cornea was not recovered until 21 days after administration of the test substance. It is solted to "Category 1" in the classification according to CLP.