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hexasodium 5-({4-chloro-6-[{2-[(4-{[4-chloro-6-({8-hydroxy-3,6-disulfonato-7-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}phenyl)sulfonyl]ethyl}(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate
EC number: 943-299-1 | CAS number: -
- 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
![](https://poisoncentres.echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Skin irritation / corrosion
Administrative data
- Endpoint:
- skin irritation: in vivo
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- From February 06, 2017 to May 18, 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 404 (Acute Dermal Irritation / Corrosion)
- GLP compliance:
- yes
Test material
- Reference substance name:
- hexasodium 5-({4-chloro-6-[{2-[(4-{[4-chloro-6-({8-hydroxy-3,6-disulfonato-7-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}phenyl)sulfonyl]ethyl}(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate
- EC Number:
- 943-299-1
- Molecular formula:
- C52H46Cl2N14O29S9 . 6 Na
- IUPAC Name:
- hexasodium 5-({4-chloro-6-[{2-[(4-{[4-chloro-6-({8-hydroxy-3,6-disulfonato-7-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]-1-naphthyl}amino)-1,3,5-triazin-2-yl]amino}phenyl)sulfonyl]ethyl}(2-hydroxyethyl)amino]-1,3,5-triazin-2-yl}amino)-4-hydroxy-3-[(4-{[2-(sulfonatooxy)ethyl]sulfonyl}phenyl)diazenyl]naphthalene-2,7-disulfonate
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
Constituent 1
Test animals
- Species:
- rabbit
- Strain:
- New Zealand White
- Details on test animals or test system and environmental conditions:
- - Source: the animal health research institute, council of agriculture, executive yuan
- Age at study initiation: approximately 4 to 5 months
- Weight at study initiation: 2924 to 3276 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: 12hrs dark / 12hrs light
Test system
- Type of coverage:
- occlusive
- Preparation of test site:
- shaved
- Vehicle:
- water
- Remarks:
- Water for injection (WFI)
- Controls:
- yes, concurrent vehicle
- Amount / concentration applied:
- - Amount(s) applied (volume or weight with unit): 0.5 g test article was moistened with 0.4 mL water for injection
- Duration of treatment / exposure:
- 4-4.5 hours
- Observation period:
- 1, 24, 48 and 72 hours
- Number of animals:
- three
- Details on study design:
- - Area of exposure: left dorsal area
- Washing (if done): with lukewarm water
Results and discussion
In vivo
Resultsopen allclose all
- Irritation parameter:
- erythema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- edema score
- Basis:
- mean
- Time point:
- 24/48/72 h
- Score:
- 0
- Max. score:
- 0
- Remarks on result:
- no indication of irritation
- Irritation parameter:
- primary dermal irritation index (PDII)
- Time point:
- 24/48/72 h
- 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) |
Clinical observation |
|
D1 |
D4 |
D4-D1 |
||
1 |
2956 |
2955 |
-1 |
Normal |
2 |
2924 |
3057 |
133 |
Normal |
3 |
3276 |
3354 |
78 |
Normal |
Table 2. Individual Scores and Total Scores for Skin Irritation During 72 hours
Animal ID |
Observation point |
Erythema |
Edema |
Control Site |
|||
1 |
1 h |
0 |
0 |
24 h |
0 |
0 |
|
48 h |
0 |
0 |
|
72 h |
0 |
0 |
|
2 |
1 h |
0 |
0 |
24 h |
0 |
0 |
|
48 h |
0 |
0 |
|
72 h |
0 |
0 |
|
3 |
1 h |
0 |
0 |
24 h |
0 |
0 |
|
48 h |
0 |
0 |
|
72 h |
0 |
0 |
|
Test Site |
|||
1 |
1 h |
0 |
0 |
24 h |
0 |
0 |
|
48 h |
0 |
0 |
|
72 h |
0 |
0 |
|
2 |
1 h |
0 |
0 |
24 h |
0 |
0 |
|
48 h |
0 |
0 |
|
72 h |
0 |
0 |
|
3 |
1 h |
0 |
0 |
24 h |
0 |
0 |
|
48 h |
0 |
0 |
|
72 h |
0 |
0 |
|
Total irritation score = 0 |
|||
PII = 0 |
Total irritation score = The sum of irritation score got from test site at 24, 48 and 72h minus the sum of irritation score got from control site at the same time points.
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- According to OECD 404 test method and Draize Dermal Classification System, the PII for CR SB32N2 in intact skin was 0 and CR SB32N2 was categorized as non-irritant. CR SB32N2 was not met classification on GHS criteria.
- Executive summary:
This test using the procedures outlined in the QPS Taiwan Study Plan for T65316009-IR which is based on the SOP for the OECD 404 (CTPS-TE00440) and OECD 404 (OECD, 2015). The sites were grades for erythema and edema at 1, 24, 48 and 72 hours after the patches removal. No clinical signs of toxicity were found. Body weight changes were within the normal range in all animals. Neither erythema nor edema was observed within 72 hours. The Primary Irritation Index for CR SB32N2 was calculated to be 0. On the basis of the test results given above and according to Draize Dermal Classification System, the response of CR SB32N2 was categorized as non-irritant.
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