Registration Dossier

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:
2014-11-24~2014-11-28
Reliability:
1 (reliable without restriction)

Data source

Reference
Reference Type:
other company data
Title:
Unnamed
Year:
2014
Report Date:
2014

Materials and methods

Test guideline
Qualifier:
according to
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Reference
Name:
Unnamed
Type:
Constituent
Test material form:
solid: particulate/powder
Remarks:
migrated information: powder
Details on test material:
- Name of test material (as cited in study report):Everdirect SH05(DR224)
- Substance type:Powder
- Composition of test material, percentage of components:68.89%
- Lot/batch No.:4501
- Expiration date of the lot/batch:2016-10-31
- Storage condition of test material:Refrigeration (5 ± 3℃)

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White

Test system

Vehicle:
unchanged (no vehicle)
Duration of treatment / exposure:
A dose of 0.1 g test article was applied to the conjunctival sac of the left eye of each rabbit. After application, the lid were gently held together for about 5~10 seconds. And right eye of each rabbits was served as blank control.
Observation period (in vivo):
1, 24, 48, 72 hours after test article application
Number of animals or in vitro replicates:
Three female New Zealand white rabbits

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Remarks:
Opacity, Area
Basis:
animal: 67
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Remarks on result:
other: test group : left eye ; blank control group : right eye
Irritation parameter:
conjunctivae score
Remarks:
Redness, Chemosis, Discharge
Basis:
animal: 67
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Remarks on result:
other: test group : left eye ; blank control group : right eye
Irritation parameter:
iris score
Basis:
animal: 67
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Remarks on result:
other: test group : left eye ; blank control group : right eye
Irritation parameter:
cornea opacity score
Remarks:
Opacity, Area
Basis:
animal: 68
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Remarks on result:
other: test group : left eye ; blank control group : right eye
Irritation parameter:
conjunctivae score
Remarks:
Redness, Chemosis, Discharge
Basis:
animal: 68
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Remarks on result:
other: test group : left eye ; blank control group : right eye
Irritation parameter:
iris score
Basis:
animal: 68
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Remarks on result:
other: test group : left eye ; blank control group : right eye
Irritation parameter:
cornea opacity score
Remarks:
Opacity, Area
Basis:
animal: 69
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Remarks on result:
other: test group : left eye ; blank control group : right eye
Irritation parameter:
conjunctivae score
Remarks:
Redness, Chemosis, Discharge
Basis:
animal: 69
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Remarks on result:
other: test group : left eye ; blank control group : right eye
Irritation parameter:
iris score
Basis:
animal: 69
Time point:
other: 1, 24, 48 and 72 hours
Score:
0
Remarks on result:
other: test group : left eye ; blank control group : right eye

Any other information on results incl. tables

Table 1 : Body weight of the rabbits

Animal I.D.

Sex

Body weight (kg)

Day 1

Day 4

67

Female

2.0708

2.1146

68

Female

2.0906

2.1350

69

Female

2.1026

2.1906

Table 2 : Individual response of the test rabbits

Animal I.D.

Time (hour)

 

Grades of the irritation reaction

Cornea

Conjunctivae

Iris

Opacity

Area

Redness

Chemosis

Discharge

67

1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

24

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

48

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

72

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

68

1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

24

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

48

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

72

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

69

1

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

24

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

48

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

72

Test

0

0

0

0

0

0

Control

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
not irritating
Remarks:
Migrated information Criteria used for interpretation of results: OECD GHS
Conclusions:
The local irritation response of the rabbit eye were evaluated within 72 hours after the application. The result of this study indicated that all the three rabbit did not show any eye irritation response after application of the test article.
Executive summary:

According to OECD Guideline 405 (Acute Eye Irritation / Corrosion), the test article was considered as non-irritant on the eye of the New Zealand white rabbits. The test results are "not irritating", so that hazard category in CLP is not classified.