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EC number: 305-729-0 | CAS number: 95009-01-1
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- April 11, 2016 - Dec 07, 2016
- 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)
- Version / remarks:
- OECD 405:2012
- Deviations:
- no
- GLP compliance:
- yes
Test material
- Reference substance name:
- Sodium [4-[[dihydroxy[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]benzenesulphonato(3-)]cuprate(1-)
- EC Number:
- 305-729-0
- EC Name:
- Sodium [4-[[dihydroxy[(2-hydroxy-3,5-dinitrophenyl)azo]phenyl]azo]benzenesulphonato(3-)]cuprate(1-)
- Cas Number:
- 95009-01-1
- Molecular formula:
- C18H9CuN6O10S.Na
- IUPAC Name:
- Reaction products of diazotized 4-aminobenzenesulfonic acid coupled with resorcinol subsequently coupled with diazotised 2-amino-4,6-dinitrophenol, copper (2+) complexes, sodium salts
- Test material form:
- solid: particulate/powder
- Details on test material:
- - Name of test material (as cited in study report): Everlan SL65
- Substance type: Powder
- Composition of test material, percentage of components: 71.19%
- Lot/batch No.: 3010
- Storage condition of test material: Ambient
Constituent 1
Test animals / tissue source
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or tissues and environmental conditions:
- - Source: WEI XIN HANG
- Weight at study initiation: 2.2684-2.3236 kg
- Housing: individually in a stainless steel wire mesh cage
- Water: ad libitum
- Acclimation period: 7 days
- Temperature (°C): 21 ± 2 °C
- Humidity (%): 55 ± 15%
- 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
- Duration of treatment / exposure:
- 1 hour
- Observation period (in vivo):
- 1, 24, 48, 72 hours
- Number of animals or in vitro replicates:
- three female rabbits
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:
- 0.3
- Max. score:
- 1
- Reversibility:
- fully reversible within: 24hr
- Remarks on result:
- probability of weak irritation
- Irritation parameter:
- chemosis score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 1.3
- Max. score:
- 2
- Reversibility:
- fully reversible within: 24hr
- Remarks on result:
- probability of weak irritation
Any other information on results incl. tables
Table 1. Body weight of the rabbits
Animal ID |
Sex |
Body weight (kg) |
|
Day 1 |
Day 4 |
||
37 |
Female |
2.2759 |
2.2789 |
38 |
Female |
2.2684 |
2.2709 |
39 |
Female |
2.3236 |
2.3259 |
Table 2. Individual response of the test rabbits
Animal I.D. |
Timea (hour) |
|
Grades of the irritation reaction |
|||||
Cornea |
Conjunctivae |
Iris |
||||||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
||||
37 |
1 |
Testb |
0 |
0 |
0 |
4 |
2 |
0 |
Controlc |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 ± 1 |
Test |
0 |
0 |
0 |
2 |
1 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
72 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
38 |
1 |
Test |
0 |
0 |
3 |
4 |
2 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 ± 1 |
Test |
0 |
0 |
1 |
2 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
72 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
39 |
1 |
Test |
0 |
0 |
1 |
3 |
2 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 ± 1 |
Test |
0 |
0 |
0 |
1 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
48 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
72 ± 1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
|
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
a Observation time was started after application of the test article
b Left eye of the test rabbits
c Right eye of the test rabbits
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 405 test method, Everlan SL65 did not show that positive irritant to the eye. Therefore, Everlan SL65 was not met a category based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for M62-151100102001EN which is based on the SOP for the OECD 405 (SOPP-306) and OECD 405 (OECD, 2012). There were no test article effects on body weight. Everlan SL65 was given by a single ocular application at 0.1 g amount to NZW female rabbits and followed by ocular examination within 72 hours and a 4 days clinical observation period. Cornea and iris with score 0 during all study period. Irritant reaction that caused by test article was disappeared within 48 hours after dosing. On the basis of the test results given above, the response of the test article did not cause positive irritating to the eye.
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