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EC number: 942-710-1 | CAS number: -
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- Irritation / corrosion
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- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
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- Additional toxicological data

Eye irritation
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 1, 2016. single exposure, 96 hours observation period (revsersible)
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 016
- 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
- Reference substance name:
- 2-[{6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)(methyl)amino]-1-hydroxy-3-sulfonaphthalen-2-yl}diazenyl]naphthalene-1,5-disulfonic acid, lithium sodium salts
- EC Number:
- 942-710-1
- Molecular formula:
- Not applicable; this UVCB substance contains: C24H15ClN7O10S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 713.8 < MW < 762.0 g/mol (UVCB substance), C24H16N7O11S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 695.4 < MW < 743.5 g/mol (UVCB substnace), C21H14N3O10S3.xLi.yNa, (x + y) = 3; 0 < (x,y) < 3 with 585.3 < MW < 633.5 g/mol (UVCB substnace), and traces of NaCl.
- IUPAC Name:
- 2-[{6-[(4-amino-6-chloro-1,3,5-triazin-2-yl)(methyl)amino]-1-hydroxy-3-sulfonaphthalen-2-yl}diazenyl]naphthalene-1,5-disulfonic acid, lithium sodium salts
- Test material form:
- solid: particulate/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 at study initiation: 4-5 months
- Weight at study initiation: 3274-3503 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 hour
- 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:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 48hr
- 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 |
||
1 |
3491 |
3511 |
20 |
Normal |
2 |
3274 |
3397 |
123 |
Normal |
3 |
3503 |
3552 |
49 |
Normal |
Table 2. Eye Irritation Scores at Observation Point (hours) on Treated Eye
Animal ID |
1 |
2 |
3 |
|||||||||
Score on each observation point (hour) |
||||||||||||
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
1 |
24 |
48 |
72 |
|
Cornea |
||||||||||||
Degree of density |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Iris |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
Conjunctiva |
||||||||||||
Redness |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
0 |
Chemosis |
1 |
1 |
0 |
0 |
0 |
1 |
0 |
0 |
1 |
0 |
0 |
0 |
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 405 test method, CJ302 showed that no positive irritant to the eye. Therefore, CJ302 was not met GHS criteria.
- Executive summary:
This test using the procedures outlined in the QPS Taiwan Study Plan for T65315008-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. Reversible redness of conjunctivae and chemosis with score of 1 were observed within 24 hours after test article application.CJ302 was given by a single ocular application at 100 mg amount to NZW male rabbits and followed by ocular examination within 72 hours and a 4 days clinical observation period. Conjunctiva redness and chemosis with score 1 were determined within 24 hours and fully recovered. On the basis of the test results given above, the response of the test article was not judged as a positive irritant to the eye.
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