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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
Guideline:
OECD Guideline 405 (Acute Eye Irritation / Corrosion)
GLP compliance:
yes

Test material

Constituent 1
Chemical structure
Reference substance name:
5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfo-2-naphthyl)diazenyl]naphthalene-2,7-disulfonic acid, lithium sodium salts
EC Number:
942-803-7
Molecular formula:
Not applicable; this UVCB substance contains: C31H21ClN7O10S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 804.0 < MW < 852.1 g/mol (UVCB substance), C31H22N7O11S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 785.5 < MW < 833.7 g/mol (UVCB substnace), and traces of NaCl and Na2SO4.
IUPAC Name:
5-({4-chloro-6-[ethyl(phenyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(1-sulfo-2-naphthyl)diazenyl]naphthalene-2,7-disulfonic acid, lithium sodium salts
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: 2918-3614 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 hrs
Observation period (in vivo):
1 hr, 24 hr, 48 hr, 72 hr, 7 day, 14 day
Number of animals or in vitro replicates:
Three

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
mean
Remarks:
2 more reaction ones
Time point:
24/48/72 h
Score:
1.9
Max. score:
2
Reversibility:
fully reversible within: 14 day
Remarks on result:
positive indication of irritation
Irritation parameter:
iris score
Basis:
mean
Remarks:
2 more reation ones
Time point:
24/48/72 h
Score:
0.5
Max. score:
1
Reversibility:
fully reversible within: 72 hr
Remarks on result:
probability of weak irritation
Irritation parameter:
conjunctivae score
Basis:
mean
Remarks:
2 higher rection ones
Time point:
24/48/72 h
Score:
2.3
Max. score:
3
Reversibility:
fully reversible within: 14 days
Remarks on result:
positive indication of irritation
Irritation parameter:
chemosis score
Basis:
mean
Remarks:
2 more reaction ones
Time point:
24/48/72 h
Score:
2.6
Max. score:
4
Reversibility:
fully reversible within: 14 days
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)

Clinical observation

D1

D4

D4-D1

10

2957

3011

54

Normal

11

2918

2913

-5

Normal

12

3614

3661

47

Normal

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

Animal ID

10

11

12

Score on each observation point

1

hr

24hr

48hr

72

hr

7

day

14 day

1

hr

24

hr

48 hr

72 hr

7

day

14

day

1

hr

24

hr

48

hr

72

hr

7

day

14

day

Cornea

Degree of density

3

2

2

2

1

0

0

1

2

2

2

0

0

0

0

0

0

0

Area1of opacity

3

4

1

3

2

0

0

2

1

2

2

0

0

0

0

0

0

0

Iris

NA

1

0

0

02

0

0

1

1

02

02

0

0

02

0

02

02

0

Conjunctiva

Redness

2

3

2

2

1

0

0

3

3

1

1

0

1

1

1

1

1

0

Chemosis

2

4

4

2

0

0

1

3

2

1

1

0

2

1

1

0

1

0

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

2:Iris discoloration

NA: the iris could not be observed since cornea opacity

Applicant's summary and conclusion

Interpretation of results:
Category 2 (irritating to eyes) based on GHS criteria
Conclusions:
According to OECD 405 test method, CJ306 showed that positive irritant to the eye and reversible. Therefore, CJ306 was categorized as irritating to eyes (Category 2) base on GHS criteria.
Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65315010-IR which is based on the SOP for the OECD 405 (CTPS-TE00441) and OECD 405 (OECD, 2012).There were no test article effects on mortality, clinical observations and body weight.CJ306 was given by a single ocular application at 100 mg amount toNZW male rabbits andfollowed 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 article was judged as a positive irritant to the eye.

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