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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
Remarks:
migrated information: 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: 2035-2278 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, 72 hours
Number of animals or in vitro replicates:
Three

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #10, #11 and #12
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #10, #11 and #12
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
conjunctivae score
Basis:
animal: #10, #11 and #12
Time point:
24/48/72 h
Max. score:
1
Reversibility:
fully reversible within: 72 hours
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #10, #11 and #12
Time point:
24/48/72 h
Max. score:
0.66
Reversibility:
fully reversible within: 48 hours
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 between D1 and D4

D1

D4

10

2035

2224

189

Normal

11

2278

2324

46

Normal

12

2168

2312

144

Normal

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

Animal I.D.

Observation point

Cornea (D/A3)1

Iris

Conjunctivae (R/D)2

10

1 h4

1/3

0

3/2

24 h

0/-

0

2/2

48 h

0/-

0

0/0

72 h

0/-

0

0/0

11

1 h4

1/3

0

2/2

24 h

0/-

0

2/2

48 h

0/-

0

1/0

72 h

0/-

0

0/0

12

1 h4

1/3

0

2/2

24 h

0/-

0

2/2

48 h

0/-

0

1/0

72 h

0/-

0

0/0

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

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

3 Areaof corneal opacity involved : 1 = less than one-quarter; 2 = graeter 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

4 Eye rinsed with saline at this time point

-: Not available

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 405 test method, CJ321 showed that positive irritant to the eye. Therefore, CJ321 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65316007-IR which is based on the SOP for the OECD 405 (CTPS-TE00441) and OECD 405 (OECD, 2012).CJ321 was given by a single ocular application at 0.1 g amount toNZW female rabbits and followed by ocular examination and clinical observation for 4 days. There were no test article effects on body weight. Reversible corneal opacity, conjunctivalredness, or chemosiswas observed within 72 hours after test article application.On the basis of the test results given above, the response of the test article was judged as a positive irritant to the eye.