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EC number: 815-135-8 | CAS number: 1386899-40-6
Eye irritation
Administrative data
- Endpoint:
- eye irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From October 03, 2017 to March 06, 2018
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 018
- Report date:
- 2018
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:
- 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[2-[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-6-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:5)
- EC Number:
- 815-135-8
- Cas Number:
- 1386899-40-6
- Molecular formula:
- C26H25N5O22S7.5Na
- IUPAC Name:
- 2,7-Naphthalenedisulfonic acid, 4-amino-5-hydroxy-3-[2-[3-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-6-[2-[2-sulfo-4-[[2-(sulfooxy)ethyl]sulfonyl]phenyl]diazenyl]-, sodium salt (1:5)
- 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: Lohas
- Weight at study initiation: above 2.0 kg
- Housing: one animal per 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 hours
- 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: #177, #178 and #179
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- iris score
- Basis:
- animal: #177, #178 and #179
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- conjunctivae score
- Basis:
- animal: #177, #178 and #179
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- chemosis score
- Basis:
- animal: #177, #178 and #179
- Time point:
- 24/48/72 h
- Score:
- 0
- Remarks on result:
- no indication of 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 |
||
177 |
Male |
3.02 |
3.10 |
178 |
Male |
2.89 |
2.93 |
179 |
Male |
2.70 |
2.80 |
Table 2. Eye response of the eye irritation test
Animal I.D. |
Timea (hour) |
Group |
Grades of the irritation reaction |
|||||
Cornea |
Conjunctivae |
Iris |
||||||
Opacity |
Area |
Redness |
Chemosis |
Discharge |
||||
177 |
1 |
Testb |
0 |
0 |
0 |
0 |
0 |
0 |
Controlc |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 ± 1 |
Test |
0 |
0 |
0 |
0 |
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 |
||
178 |
1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 ± 1 |
Test |
0 |
0 |
0 |
0 |
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 |
||
179 |
1 |
Test |
0 |
0 |
0 |
0 |
0 |
0 |
Control |
0 |
0 |
0 |
0 |
0 |
0 |
||
24 ± 1 |
Test |
0 |
0 |
0 |
0 |
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, CR SB37 showed that no irritant to the eye. Therefore, CR SB37 was not met a category based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for M62-170900009002EN 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. CR SB37 was given by a single ocular application at 0.1 g amount toNZW male rabbits and followed by ocular examination within 72 hours. Three rabbits did not show any eye irritation response after application of CR SB37 and irritation responses were 0. On the basis of the test results given above, the response of CR SB37 was not any irritant to the eye.
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