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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:
From December 23, 2016 to April 13, 2017
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2017
Report Date:
2017

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

Test animals / tissue source

Species:
rabbit
Strain:
New Zealand White
Details on test animals or tissues and environmental conditions:
- Source: the animal health research institute, council of agriculture, executive yuan
- Age: approximately 2-3 months
- Weight at study initiation: 2189-2410 g
- Housing: individually in a stainless steel wire mesh cage
- Water: ad libitum
- Acclimation period: at least 5 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 50 ± 20%
- Photoperiod: 12-hrs dark / 12-hrs light

Test system

Vehicle:
unchanged (no vehicle)
Controls:
yes, concurrent no treatment
Amount / concentration applied:
- Amount(s) applied (volume or weight with unit): 0.1 g
Observation period (in vivo):
1, 24, 48 and 72 hours, 7 and 14 days
Number of animals or in vitro replicates:
Three

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #01
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: #02
Time point:
24/48/72 h
Score:
0.66
Reversibility:
fully reversible within: 72hours
Remarks on result:
positive indication of irritation
Irritation parameter:
cornea opacity score
Basis:
animal: #03
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
animal: #01, 02 and 03
Time point:
24/48 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #01
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #02
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48hours
Remarks on result:
positive indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #03
Time point:
24/48/72 h
Score:
1
Reversibility:
fully reversible within: Day 7
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #01
Time point:
24/48/72 h
Score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #02 and 03
Time point:
24/48/72 h
Score:
0.33
Reversibility:
fully reversible within: 48hours
Remarks on result:
positive indication of irritation

Any other information on results incl. tables

Table 1. Individual Body Weights and Clinical Observations

Animal ID

Body weight (g)

Body weight change (g)

(D4-D1)

Clinical observation

D1

D4

01

2189

2262

73

Normal1

02

2410

2483

73

Normal1

03

2327

2406

79

Normal2

1: D1-D7

2: D1-D14

 

Table 2. Eye Irritation Scores at Observation Point on Treated Eye

Animal I.D.

Observation point

Cornea (D/A5)1

Iris

Conjunctivae (R/D)2

01

1 h4

0/-

0

2/1

24 h

0/-

03

0/0

48 h

0/-

03

0/0

72 h

0/-

03

0/0

D7

-

Normal

-

02

1 h

0/-

0

2/1

24 h

1/1

03

1/1

48 h

1/1

03

0/0

72 h

0/-

03

0/0

D7

-

Normal

-

03

1 h

0/-

0

2/1

24 h

1/1

03

1/1

48 h

0/-

03

1/0

72 h

0/-

03

1/0

D7

0/-

03

0/0

D14

-

Normal

-

1(D/A) = (Degree of density/Area of opacity)                                                                

2(R/D) = (Redness/Chemosis)

3Red colored iris

4Eye rinsed with saline at this time point

5Area of corneal opacity involved: 1=less than one-quarter; 2=greater than one-quarter but less than half; 3=greater than half but less than three-quarter; 4=greater than three-quarter, up to whole area

-: Not available

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 405 test method, CJ305 showed that positive irritant to the eye. Therefore, CJ305 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65316004-IR which is based on the SOP for the OECD 405 (CTPS-TE00441) and OECD 405 (OECD, 2012). CJ305 was given by a single ocular application at 0.1 g amount to NZW female rabbits and followed by ocular examination and clinical observation no more than 14 days. There were no test article effects on body weight. No irritation reaction in iris. Reversible corneal opacity, conjunctiva redness and chemosis were observed within 7 days. On the basis of the test results given above, CJ305 showed the light irritation to eyes. However, the result has not met a category based on GHS criteria.