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EC number: 855-027-8 | CAS number: 2409921-75-9
- Life Cycle description
- Uses advised against
- Endpoint summary
- Appearance / physical state / colour
- Melting point / freezing point
- Boiling point
- Density
- Particle size distribution (Granulometry)
- Vapour pressure
- Partition coefficient
- Water solubility
- Solubility in organic solvents / fat solubility
- Surface tension
- Flash point
- Auto flammability
- Flammability
- Explosiveness
- Oxidising properties
- Oxidation reduction potential
- Stability in organic solvents and identity of relevant degradation products
- Storage stability and reactivity towards container material
- Stability: thermal, sunlight, metals
- pH
- Dissociation constant
- Viscosity
- Additional physico-chemical information
- Additional physico-chemical properties of nanomaterials
- Nanomaterial agglomeration / aggregation
- Nanomaterial crystalline phase
- Nanomaterial crystallite and grain size
- Nanomaterial aspect ratio / shape
- Nanomaterial specific surface area
- Nanomaterial Zeta potential
- Nanomaterial surface chemistry
- Nanomaterial dustiness
- Nanomaterial porosity
- Nanomaterial pour density
- Nanomaterial photocatalytic activity
- Nanomaterial radical formation potential
- Nanomaterial catalytic activity
- Endpoint summary
- Stability
- Biodegradation
- Bioaccumulation
- Transport and distribution
- Environmental data
- Additional information on environmental fate and behaviour
- Ecotoxicological Summary
- Aquatic toxicity
- Endpoint summary
- Short-term toxicity to fish
- Long-term toxicity to fish
- Short-term toxicity to aquatic invertebrates
- Long-term toxicity to aquatic invertebrates
- Toxicity to aquatic algae and cyanobacteria
- Toxicity to aquatic plants other than algae
- Toxicity to microorganisms
- Endocrine disrupter testing in aquatic vertebrates – in vivo
- Toxicity to other aquatic organisms
- Sediment toxicity
- Terrestrial toxicity
- Biological effects monitoring
- Biotransformation and kinetics
- Additional ecotoxological information
- Toxicological Summary
- Toxicokinetics, metabolism and distribution
- Acute Toxicity
- Irritation / corrosion
- Sensitisation
- Repeated dose toxicity
- Genetic toxicity
- Carcinogenicity
- Toxicity to reproduction
- Specific investigations
- Exposure related observations in humans
- Toxic effects on livestock and pets
- 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 January 4, 2019 to March 14, 2019
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 019
- Report date:
- 2019
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-Naphthalenesulfonic acid, 7-amino-4-hydroxy-, coupled with diazotized 2-amino-5-[[2-(sulfooxy)ethyl]sulfonyl]benzenesulfonic acid and diazotized dehydrochlorinated 2-amino-4-[[4-[(2-chloroethyl)sulfonyl]-1-oxobutyl]amino]benzenesulfonic acid, sodium salts
- EC Number:
- 833-951-2
- Cas Number:
- 2246977-27-3
- Molecular formula:
- C8H11NO9S3.C10H9NO4S.C12H17ClN2O6S2.Na
- IUPAC Name:
- 2-Naphthalenesulfonic acid, 7-amino-4-hydroxy-, coupled with diazotized 2-amino-5-[[2-(sulfooxy)ethyl]sulfonyl]benzenesulfonic acid and diazotized dehydrochlorinated 2-amino-4-[[4-[(2-chloroethyl)sulfonyl]-1-oxobutyl]amino]benzenesulfonic acid, 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: WEI XIN HANG
- Weight at study initiation: 2.00-2.60 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 vehicle
- 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 ± 1, 48 ± 1, 72 ± 1 hours
- Number of animals or in vitro replicates:
- three
- Details on study design:
- After evaluating, test article had not been judged to be corrosive, so test article did not perform preliminary test and directly applied on main test.
The form of test article is powder and the test article (0.1g) was directly applied to the conjunctival sac of the left eye of each rabbits, then cover the eye for 5 seconds to prevent the test article following out. The right eye does not perform any test as blank control. The test article has not been removed from the eye of the test animal by physiological mechanisms at the first observation time point of 1 hour after treatment, the eye were rinsed with physiological saline. There was no anesthetic treatment during the study period.
Both eyes of the three rabbits were examined and grading at 1, 25, 49, and 73 hours after test article application according to the grades of: System for grading ocular lesions”.
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
- Max. 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 | Day 1 | Day 4 |
153 | male | 2.08 | 2.60 |
154 | male | 2.00 | 2.07 |
155 | male | 2.00 | 2.10 |
Table 2. Individual skin reactions
Animal ID | Timea(hours) |
Test dosing |
Grades of the irritation reaction Cornea Conjunctivae Opacity Area Redness Chemosis Discharge Iris |
|||||
156 |
1 |
Testb |
0 |
0 |
0 |
0 |
0 | 0 |
156 |
25 |
-c |
0 |
0 | 0 | 0 | 0 | 0 |
156 | 49 | Testb |
0 | 0 | 0 | 0 | 0 | 0 |
156 | 73 | -c |
0 |
0 |
0 |
0 |
0 | 0 |
157 |
1 |
Testb |
0 |
0 |
0 |
0 |
0 | 0 |
157 |
25 |
-c |
0 |
0 |
0 |
0 |
0 | 0 |
157 |
49 |
Testb |
0 |
0 |
0 |
0 |
0 | 0 |
157 |
73 |
-c |
0 |
0 |
0 |
0 |
0 | 0 |
158 |
1 |
Testb |
0 |
0 |
0 |
0 |
0 | 0 |
158 |
25 |
-c |
0 |
0 |
0 |
0 |
0 | 0 |
158 |
49 |
Testb |
0 |
0 |
0 |
0 |
0 | 0 |
158 |
73 |
-c |
0 |
0 |
0 |
0 |
0 | 0 |
aObservation time was started after application of the test article.
bLeft eye of the test rabbits were dosed with test article.
cRight eye of the test rabbits were not perform any test as blank control.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 405 test method, CR SB33 showed that no irritant to the eye. Therefore, CR SB33 was not met a category based on GHS criteria.
- Executive summary:
This test using the procedures outlined in the SuperLab Study Plan for MZ6-181200023 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. Both eyes of the test animals were examined at 1, 25, 49, and 73 hours after the test article application. Results indicated that all of the three rabbits did not show any eye irritation response within the observation period, grades of the irritation reaction were 0. Therefore, the test article CR SB33 did not cause any irritation response on the eye of rabbits under the conditions designed for this study and did not classify as eye irritants.
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