Registration Dossier
Registration Dossier
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EC number: - | CAS number: -
Eye irritation
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:
- 2 017
- 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
- Reference substance name:
- Reaction products of 1,4-Benzenedisulfonic acid, 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfo-1-naphthalenyl]azo]sulfo-1-naphthalenyl]azo]-, tetrasodium salt and lithium chloride
- 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:
- Reaction products of 1,4-Benzenedisulfonic acid, 2-[[4-[[4-[(4-amino-6-chloro-1,3,5-triazin-2-yl)amino]-5-sulfo-1-naphthalenyl]azo]sulfo-1-naphthalenyl]azo]-, tetrasodium salt and lithium chloride
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
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.
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