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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 April 15, 2016 to June 01, 2016
Reliability:
1 (reliable without restriction)
Rationale for reliability incl. deficiencies:
guideline study

Data source

Reference
Reference Type:
study report
Title:
Unnamed
Year:
2016
Report Date:
2016

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 at study initiation: 4-5 months
- Weight at study initiation: 2946-3750 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): 100 mg
Duration of treatment / exposure:
1 hr
Observation period (in vivo):
1 hr, 24 hr, 48 hr, 72 hr, 7 day and 14 day
Number of animals or in vitro replicates:
three

Results and discussion

Results of in vivo studyopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
mean of 2 higher reacted ones
Time point:
24/48/72 h
Score:
1.5
Max. score:
2
Reversibility:
fully reversible within: 14 day
Remarks on result:
probability of weak irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
mean of 2 higher reacted ones
Time point:
24/48/72 h
Score:
0.33
Max. score:
1
Reversibility:
fully reversible within: 14 d
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
mean of 2 higher reacted ones
Time point:
24/48/72 h
Score:
2.35
Max. score:
3
Reversibility:
fully reversible within: 14 d
Remarks on result:
probability of mild irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
mean of 2 higher reacted ones
Time point:
24/48/72 h
Score:
1.5
Max. score:
2
Reversibility:
fully reversible within: 14 d
Remarks on result:
probability of weak 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)

Clinical observation

D1

D4

D4-D1

7

3750

3772

22

Normal

8

2966

2876

-90

Normal

9

2946

2888

-58

Normal

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

Animal ID

7

8

9

Score on each observation point

1

hr

24

hr

48

hr

72

hr

7

day

1

hr

24

hr

48

hr

72

hr

7

day

14

day

1

hr

24

hr

48

hr

72

hr

7

day

Cornea

Degree of density

0

0

0

0

0

1

2

1

1

0

0

1

2

2

1

0

Area1of opacity

0

0

0

0

0

3

3

1

1

0

0

3

2

1

1

0

Iris

0

02

02

02

02

0

12

02

02

02

02

0

12

02

02

02

Conjunctive

Redness

0

2

1

2

0

2

3

3

3

1

0

2

2

1

2

0

Chemosis

2

1

0

0

0

3

2

2

1

0

0

3

2

1

1

0

1: Score 1: 1/4 (or less) not zero; Score 2: greater than 1/4 but less than 1/2; Score 3: great that 1/2, but less than 3/4; Score 4: greater than 3/4, up to whole area.

2: Iris discoloration

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
According to OECD 405 test method, CJ304 showed that a positive irritant to the eye and reversible. Therefore, CJ304 was categorized as irritant to eye (Category 2) based on GHS criteria.
Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65315009-IR which is based on the SOP for the OECD 405 (CTPS-TE00441) and OECD 405 (OECD, 2012).There were no effects on mortality.Slight body weight decreased was observed but all animals were clinically normal. Grade 2 corneal opacity in over 50% of area, grade 1 hyperemia of iris and grade 3 diffused redness and eversion of conjunctiva were observed in rabbits during 72 h after dosing.Until D14, all eye irritation effects were not observed. Moreover, iris discoloration was observed.CJ304 was given by a single ocular application at 100 mg amount to NZW male rabbits and followed by ocular examination and clinical observation for 14 days. Reversible corneal opacity, hyperemia of iris, and conjunctiva redness and chemosis were observed within 14 days.On the basis of the test results given above, the response of the test articlewas judged as a positive irritant to the eye.