Registration Dossier

Diss Factsheets

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

Test material

Constituent 1
Chemical structure
Reference substance name:
2-{[4-({4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfo-1-naphthyl}diazenyl)-(6 or 7)-sulfo-1-naphthyl]diazenyl}benzene-1,4-disulfonic acid, lithium sodium salts
EC Number:
943-097-3
Molecular formula:
Not applicable; this UVCB substance contains: C29H16ClN9O12S4.xLi.yNa, (x + y) = 4; 0 < (x,y) < 4 with 873.9 < MW < 938.1 g/mol (UVCB substance), and traces of NaCl.
IUPAC Name:
2-{[4-({4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfo-1-naphthyl}diazenyl)-(6 or 7)-sulfo-1-naphthyl]diazenyl}benzene-1,4-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: approximately 2-3 months
- Weight at study initiation: 2091-2470 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
Number of animals or in vitro replicates:
Three

Results and discussion

In vivo

Resultsopen allclose all
Irritation parameter:
cornea opacity score
Basis:
animal: #07, #08 and #09
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
iris score
Basis:
animal: #07, #08 and #09
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Remarks:
Light red colored iris
Irritation parameter:
conjunctivae score
Basis:
animal: #07, #08 and #09
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no indication of irritation
Irritation parameter:
chemosis score
Basis:
animal: #07, #08 and #09
Time point:
24/48/72 h
Max. score:
0
Remarks on result:
no 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

07

2470

2550

80

Normal1

08

2341

2422

81

Normal2

09

2091

2143

52

Normal1

1: D1-D4

2: D1-D21

 

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

Animal I.D.

Observation point

Cornea (D/A)1

Iris

Conjunctivae (R/D)2

07

1 h

0/-

0

1/0

24 h

0/-

0

0/0

48 h

0/-

0

0/0

72 h

0/-

0

0/0

08

1 h

0/-

0

2/1

24 h

0/-

03

0/0

48 h

0/-

03

0/0

72 h

0/-

03

0/0

D7

-

-3

-

D14

-

-3

-

D21

-

-3

-

09

1 h

0/-

0

1/0

24 h

0/-

0

0/0

48 h

0/-

0

0/0

72 h

0/-

0

0/0

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

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

3 Light red colored iris

-: Not available

Applicant's summary and conclusion

Interpretation of results:
GHS criteria not met
Conclusions:
According to OECD 405 test method, CJ313 showed that positive irritant to the eye. Therefore, CJ313 was not met a category based on GHS criteria.
Executive summary:

This test using the procedures outlined in the QPS Taiwan Study Plan for T65316006-IR which is based on the SOP for the OECD 405 (CTPS-TE00441) and OECD 405 (OECD, 2012). CJ313 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 21 days. There were no test article effects on body weight. No irritation reaction in cornea and iris. Reversible conjunctiva redness and chemosis were observed within 24 hoursafter 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.