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EC number: 481-170-7 | CAS number: 502453-61-4
- 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
- Study period:
- 2002-05-16 to 2002-11-22
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Study was conducted in general compliance with U. S. National Institute of Health publication No. 99-4494 and with OECD guideline for testing of chemicals, no. 429 "Skin sensitization: Local lymph node assay", draft document (November 2000)
Cross-referenceopen allclose all
- Reason / purpose for cross-reference:
- reference to same study
- Reason / purpose for cross-reference:
- reference to other study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 002
- Report date:
- 2002
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:
- -
- EC Number:
- 481-170-7
- EC Name:
- -
- Cas Number:
- 502453-61-4
- Molecular formula:
- Hill formula: C23H30BrN3O2 CAS formula: C23H30N3O2.Br
- IUPAC Name:
- dimethyl(3-{[4-(methylamino)-9,10-dioxo-9,10-dihydroanthracen-1-yl]amino}propyl)propylazanium bromide
- Reference substance name:
- Dimethyl-(3-(4-methylamino-9,10-dioxo-9,10-dihydro-anthracen -1-ylamino)propyl)propylammonium bromide
- IUPAC Name:
- Dimethyl-(3-(4-methylamino-9,10-dioxo-9,10-dihydro-anthracen -1-ylamino)propyl)propylammonium bromide
- Details on test material:
- - Name of test material (as cited in study report): 3-((9,10-Dihydro-9,10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N,N-dimethyl-N-propyl-1- Propanaminium-bromid (Bluequat-bromid)
- Molecular formula (if other than submission substance): C23H30N3O2Br
- Molecular weight (if other than submission substance): 460.42
- Substance type: Pure active substance
- Physical state: Solid
- Analytical purity: See below
- Impurities (identity and concentrations): None
- Composition of test material, percentage of components: See below
- Isomers composition: Not available
- Purity test date: See below
- Lot/batch No.: See below
- Expiration date of the lot/batch: See below
- Stability under test conditions: The substance on storage in dryness and darkness is considered to be stable more than 5 years
- Storage condition of test material: At room temperature, kept away from light and humidity
- Other: None
Constituent 1
Constituent 2
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo, BP 0109, 69592'Arbresle cedex, France
- Age at study initiation: 9 weeks
- Weight at study initiation: 21 to 26 grams
- Housing: Animals were housed in groups of 5 of the same dose group in plastic cages (265 x 160 x 140 mm)
- Diet (e.g. ad libitum): Mouse pelleted complete diet , ad libitum
- Water (e.g. ad libitum): Softened and filtered (0.2µm) ad libitum
- Acclimation period: 9 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19 to 25 °C
- Humidity (%): 55+/- 15%
- Air changes (per hr): Minimum 8 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hours light (artificial)/ 12 hours dark
IN-LIFE DATES: From: 2002-05-16 To: 2002-11-22
Study design: in vivo (LLNA)
- Vehicle:
- other: Acetone/water (1:1) mixed with olive oil (3 volumes of acetone/water to 1 volume of olive oil)
- Concentration:
- The test item was prepared as a solution in the vehicle at the following concentration: 1%, 2.5%, 5% and 10% (w/v)
- No. of animals per dose:
- 5 females per dose
- Details on study design:
- RANGE FINDING TESTS: Not applicable
- Compound solubility: Not applicable
- Irritation: Not applicable
- Lymph node proliferation response: Not applicable
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: LLNA of 3-((9,10-Dihydro-9,10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N,N-dimethyl-N-propyl-1-Propanaminium-bromid (Bluequat-bromid)
- Criteria used to consider a positive response: SI = or > than 3x control
TREATMENT PREPARATION AND ADMINISTRATION: The test item was prepared as a solution in the vehicle at the following concentration: 1%, 2.5%, 5% and 10% (w/v). On day 0, 1 and 2 the animals received 25 µl of one of the test item or vehicle on the the dorsal surface of each ear. - Positive control substance(s):
- other: N,N'-bis(4-Aminophenyl)-2,5-diamino-1,4-Benzochinondiimin (Bandrowski-Base)
- Statistics:
- Not available
Results and discussion
- Positive control results:
- The positive control groups were included in study 762/014 and are common to studies 762/014, 762/015 and 762/016. Positive control induced a positive response as it elicited at least a 3 fold increase in isotope incorporation relative to the vehicle, with a calculated EC3 value of 0.33%. The mean stimulation indices were 0.9, 0.7, 2.9 and 3.3 at the concentration of 0.001%, 0.01%, 0.1% and 1% respectively.
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: see Remark
- Remarks:
- Treatment of mice with 3-((9,10-Dihydro-9,10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N,N-dimethyl-N-propyl-1-Propanaminium-bromid (Bluequat-bromid) induced a negative response, as it did not elicit at least 3 fold increase in isotope incorporation relative to the vehicle. The mean stimulation indices were 0.8, 0.6, 0.6 and 0.6 at the concentration of 1%, 2.5%, 5% and 10% respectively.
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: The mean DPM values were 805, 674, 580 and 595 at the concentration of 1%, 2.5%, 5% and 10% respectively.The mean DPM value for vehicle is 1040.
Any other information on results incl. tables
|
Applicant's summary and conclusion
- Interpretation of results:
- other: not classified
- Conclusions:
- 3-((9,10-Dihydro-9,10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N,N-dimethyl-N-propyl-1-Propanaminium-bromid (Bluequat-bromid) is not a skin sensitizer.
- Executive summary:
The potential of 3-((9,10-Dihydro-9,10-dioxo-4-(methylamino)-1-anthracenyl)amino)-N,N-dimethyl-N-propyl-1-Propanaminium-bromid (Bluequat-bromid) to induce contact hypersensitivity was examined using the Murine local lymph node assay. Groups of 5 female mice in each were treated with 1%, 2.5%, 5% and 10% of test substance in vehicle (Acetone/water (1:1) mixed with olive oil) for 3 daily treatments. One group of mice was treated with vehicle (Acetone/water (1:1) mixed with olive oil). On day 5, all the animals were injected with 250 µl PBS containing 21.1 µCi of H3 methyl thymidine. Auricular lymph nodes were excised and assessed for thymidine uptake.
Treatment of mice with 3-((9,10-Dihydro-9,10-dioxo-4-(methylamino)-1-anthracenyl)amino)- N,N-dimethyl-N-propyl-1-Propanaminium-bromid (Bluequat-bromid) induced a negative response, as it did not elicit at least 3 fold increase in isotope incorporation relative to the vehicle. The mean stimulation indices were 0.8, 0.6, 0.6 and 0.6 at the concentration of 1%, 2.5%, 5% and 10% respectively.
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