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EC number: 276-817-3 | CAS number: 72749-80-5
- 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: well performed GLP and OECD guideline stiudy
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 008
- Report date:
- 2008
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Hydrogen 9-amino-7-phenyl-5-(phenylamino)-4,10-disulphonatobenzo[a]phenazinium, disodium salt
- EC Number:
- 276-817-3
- EC Name:
- Hydrogen 9-amino-7-phenyl-5-(phenylamino)-4,10-disulphonatobenzo[a]phenazinium, disodium salt
- Cas Number:
- 72749-80-5
- Molecular formula:
- C28H20N4O6S2.2Na
- IUPAC Name:
- Benzo[a]phenazinium, 9-amino-7-phenyl-5-(phenylamino)-4,10-disulfo-, inner salt, sodium salt (1:2)
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/CaOlaHsd
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Harlan Netherlands, B.V. Postbus 6174, NL - 5960 AD Horst / The Netherlands
- Age at study initiation: 8 - 12 weeks
- Weight at study initiation: 19.2 - 22.7
- Housing: Single caging, Makrolon Type I, with wire mesh top, granulated soft wood bedding
- Diet (e.g. ad libitum): pelleted standard diet, ad libitum
- Water (e.g. ad libitum): tap water, ad libitum
- Acclimation period: At least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 3
- Humidity (%): 30-70
- Photoperiod (hrs dark / hrs light): artificial light 6.00 a.m. - 6.00 p.m.
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 0.0 (control), 12.5, 25, and 50%
- No. of animals per dose:
- 4
- Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
- Statistics:
- Mean values and standard deviations were calculated for the body weights.
Results and discussion
- Positive control results:
- Test item concentration % (w/v) / S.I.
5 / 5.24
10 / 7.38
25 / 9.32
In vivo (LLNA)
Resultsopen allclose all
- Key result
- Parameter:
- SI
- Value:
- < 2.4
- Test group / Remarks:
- @ 50%
- Remarks on result:
- other: Test item concentration % (w/v) / S.I. 12.5% / 1.9 25.0% / 1.7 50.0% / 2.4
- Parameter:
- other: disintegrations per minute (DPM)
- Value:
- <= 1 470.9
- Test group / Remarks:
- @ 50%
- Remarks on result:
- other: Test item concentration % (w/v) / DPM per lymph node [ 0.0% (control) / 603.3] [12.5% / 1135.7] [25.0% / 1035.9] [50.0% / 1470.9]
Any other information on results incl. tables
Test item concentration % (w/w) |
Group |
Measurement DPM |
Calculation |
Result |
|||
DPM-BGa) |
number of lymph nodes |
DPM per lymph nodeb) |
S.I. |
||||
--- |
BG I |
43 |
--- |
--- |
--- |
--- |
|
--- |
BG II |
38 |
--- |
--- |
--- |
--- |
|
--- |
1 |
4867 |
4827 |
8 |
603.3 |
|
|
12.5 |
2 |
9126 |
9086 |
8 |
1135.7 |
1.9 |
|
25 |
3 |
8328 |
8288 |
8 |
1035.9 |
1.7 |
|
50 |
4 |
11808 |
11768 |
8 |
1470.9 |
2.4 |
BG = Background (1 ml 5% trichloroacetic acid) in duplicate
1 = Control Group
2-4 = Test Group S.I. = Stimulation Index
a) = The mean value was taken from the figures BG I and BG II
b) = Since the lymph nodes of the animals of a dose group were pooled, DPM/node was determined by dividing the measured value by the number of lymph nodes pooled
The EC3 value could not be calculated, since all S.I.´s are below 3.
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Based on the findings in this assay the test item was not a skin sensitiser.
- Executive summary:
In the study the test item suspended in dimethylformamide was assessed for its possible contact allergenic potential.
For this purpose a local lymph node assay was performed using test item concentrations of 12.5, 25, and 50%.
The animals did not show any clinical signs during the course of the study and no cases of mortality were observed. Signs of local irritation such as ear redness could not be determined due to the intense colour of the test item.
In this study Stimulation Indices (S.I.) of 1.9, 1.7, and 2.4 were determined with the test item at concentrations of 12.5, 25, and 50% in dimethylformamide, respectively.
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