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:
From 2014-12-09 to 2014-12-14
Reliability:
2 (reliable with restrictions)
Rationale for reliability incl. deficiencies:
test procedure in accordance with national standard methods with acceptable restrictions

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2015
Report date:
2015

Materials and methods

Test guidelineopen allclose all
Qualifier:
according to guideline
Guideline:
other: GB/T 21609-2008 Chemicals - Test method of acute eye irritation/corrosion
Deviations:
no
Qualifier:
equivalent or similar to guideline
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
Deviations:
no
GLP compliance:
no
Remarks:
authorized by CNAS

Test material

Constituent 1
Test material form:
solid: particulate/powder
Specific details on test material used for the study:
- Purity: 100.0%
- Lot No.: KNC110310

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
TEST ANIMALS
- Source: Tianqin biotechnology Ltd., Changsha
- Weight at study initiation: 2.0 ~ 2.3 kg
- Housing: housed in common environment
- Diet: All ofthe feeds were supplied by Tianqin Biotechnology Ltd., Changsha
- Acclimation period: at least 5 days

ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21-23
- Humidity (%): 57-62

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 100 mg
Observation period (in vivo):
4 day
Number of animals or in vitro replicates:
2 female and 2 male
Details on study design:
- Treatment of the test substance: An appropriate amount of the test substance was grinded
- Exposure: The animal left eyelid was opened lightly, and about 100 mg of the test substance was applied on the cornea, the lids are then gently held together for one second.
- Observation: The eyes were examined at 1h, 24h, 48h, 72 h and the 4th day, and the scores were recorded.

SCORING SYSTEM: Draize

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
other: All 4 animal tested
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
iris score
Basis:
other: all 4 animal tested
Time point:
24/48/72 h
Score:
0
Max. score:
0
Irritation parameter:
conjunctivae score
Basis:
animal #1
Time point:
24/48/72 h
Score:
0.67
Max. score:
2
Reversibility:
fully reversible within: 72 h
Irritation parameter:
conjunctivae score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1.33
Max. score:
2
Reversibility:
fully reversible within: 4 d
Irritation parameter:
conjunctivae score
Basis:
animal #3
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritation parameter:
conjunctivae score
Basis:
animal #4
Time point:
24/48/72 h
Score:
1
Max. score:
2
Reversibility:
fully reversible within: 72h
Irritation parameter:
chemosis score
Basis:
animal: #1 and #3
Time point:
24/48/72 h
Score:
0
Max. score:
1
Reversibility:
fully reversible within: 24 h
Irritation parameter:
chemosis score
Basis:
animal #2
Time point:
24/48/72 h
Score:
1
Max. score:
1
Reversibility:
fully reversible within: 4 d
Irritation parameter:
chemosis score
Basis:
animal #4
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 48h
Irritant / corrosive response data:
One hour after administration, the conjunctiva of the rabbits signed No.1 and No.2 were cardinal red congestion and light dropsy and having more excretion. The conjunctiva of the rabbits signed No.3 and No.4 were bright red congestion and light dropsy and having a small amount excretion. Twenty-four hours after administration, the conjunctiva of the rabbits signed No.2 and No.4 were cardinal red congestion and light dropsy and having a great quantity excretion. The dropsy of the conjunctiva of the rabbits signed No.1 and No.3 disappeared. Forty-eight hours after administration, the irritation of the four rabbits lightened. And the eye of the rabbits signed No.1, No.3 and No.4 recovered in the time of 72 h after administration. The eye of the rabbits signed No.2 recovered in the time of the 4th day. The irritation of Cornea and Iris were not observed.
Other effects:
Individual body weights were rising after exposing.

Any other information on results incl. tables

Eye Damage and Scoring:

 

Female #1

Female #2

Male #3

Male #4

1h

24h

48h

72h

1h

24h

48h

72h

1h

24h

48h

72h

1h

24h

48h

72h

cornea opacity

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

conjunctivae

2

1

1

0

2

2

1

1

1

1

0

0

1

2

1

0

chemosis

1

0

0

0

1

1

1

1

1

0

0

0

1

1

0

0

Iris

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

0

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Remarks:
Not classified
Conclusions:
The mean cornea opacity and iris scores at 24, 48 and 72 h for each animal were all 0. The mean conjunctivae scores were 0.67, 1.33, 0.33, 1 and the mean chemosis scores were 0, 1, 0, 0.33, respectively at 24, 48 and 72 h after installation. All the irritations disappeared within 4 days.
Executive summary:

The irritation/corrosion effects of the test substance on eyes of rabbit were assessed in accordance with GB/T 21609-2008 Chemicals - Test method of acute eye irritation/corrosion.

100 mg of the test substance was applied on the left cornea of 2 female and 2 male White New Zealand rabbits. The untreated right eye was used as control.

The mean cornea opacity and iris scores at 24, 48 and 72 h for each animal were all 0. The mean conjunctivae scores were 0.67, 1.33, 0.33, 1 and the mean chemosis scores were 0, 1, 0, 0.33, respectively at 24, 48 and 72 h. All the irritations disappeared within 4 days.