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Diss Factsheets
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EC number: 909-092-5 | 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
Skin sensitisation
Administrative data
- Endpoint:
- skin sensitisation: in vivo (LLNA)
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 2017
- 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 429 (Skin Sensitisation: Local Lymph Node Assay)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- BASF SE Experimental Toxicology and Ecology 67056 Ludwigshafen, Germany
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Reaction mass of 5,12-dihydroquino[2,3-b]acridine-7,14-dione and aluminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2-sulphonate) and dialuminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2,9-disulphonate)
- EC Number:
- 909-092-5
- Molecular formula:
- Unspecified
- IUPAC Name:
- Reaction mass of 5,12-dihydroquino[2,3-b]acridine-7,14-dione and aluminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2-sulphonate) and dialuminium tris(5,7,12,14-tetrahydro-7,14-dioxoquino[2,3-b]acridine-2,9-disulphonate)
- Test material form:
- solid: particulate/powder
- Details on test material:
- Batch 22426
100% UVCB
storage at room temperature
storage stability until 10 Dec 2025
Constituent 1
- Specific details on test material used for the study:
- physical appearance: solid, violet to brown
purity: 100% UVCB
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- CBA
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: xxx
- Age at study initiation: xxweeks
- Weight at study initiation: 19 - 23.5 g
- Housing: all animals in one group were housed in a cage together as a group
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 +/- 2°C
- Humidity (%): 45 – 65%
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From:
Study design: in vivo (LLNA)
- Vehicle:
- propylene glycol
- Concentration:
- 5%, 10% und 30 % (w/w)
- No. of animals per dose:
- 5
- Details on study design:
- MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: standard H-Methylthymidine incorporation
- Criteria used to consider a positive response: SI > 3
TREATMENT PREPARATION AND ADMINISTRATION: Each test group of mice was treated by topical (epidermal) application to the dorsal surface
of each ear. The application volume, 25 μL/ear/day, was spread over the entire dorsal surface (diameter 8 mm) of each ear once daily for three consecutive days. A further group of mice (control animals) was treated with an equivalent volume of the relevant vehicle alone. - Positive control substance(s):
- hexyl cinnamic aldehyde (CAS No 101-86-0)
Results and discussion
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Value:
- 1.13
- Test group / Remarks:
- 30%
- Parameter:
- SI
- Value:
- 1.15
- Test group / Remarks:
- 10%
- Parameter:
- SI
- Value:
- 0.73
- Test group / Remarks:
- 5%
- Cellular proliferation data / Observations:
- Body weight development was normal during the treatment and observation phase.
Cell counts are provided in the table below.
Any other information on results incl. tables
Table: Results for 3H-Thymidine incorporation
DPM / lymph node pair |
S.D. | Stimulation index | |
vehicle propylene glycol | 324.5 | 122.7 | 1.00 |
5% in propylene glycol | 235.6 | 100.8 | 0.73 |
10% in propylene glycol | 373.0 | 110.0 | 1.15 |
30% in propylene glycol | 367.8 | 207.9 | 1.13 |
Table: Results for Cell counts
Mean Cell [Counts / lymph node pair] |
S.D. | Stimulation Index |
|
vehicle propylene glycol | 11'102'400 | 1'680'464 | 1.00 |
5% in propylene glycol | 12'016'800 | 2'167'464 | 1.08 |
10% in propylene glycol | 12'091'200 | 2'472'639 | 1.09 |
30% in propylene glycol | 11'395'200 | 3'676'285 | 1.03 |
Table: Lymph node weight results
Lymph node weight, Mean [mg] | S.D. | Stimulation index | |
vehicle propylene glycol | 4.5 | 0.6 | 1.00 |
5% in propylene glycol | 5.1 | 0.6 | 1.13 |
10% in propylene glycol | 5.5 | 0.7 | 1.21 # |
30% in propylene glycol | 5.4 | 0.7 | 1.2# |
# = Statistically significant from control
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- .
Information on Registered Substances comes from registration dossiers which have been assigned a registration number. The assignment of a registration number does however not guarantee that the information in the dossier is correct or that the dossier is compliant with Regulation (EC) No 1907/2006 (the REACH Regulation). This information has not been reviewed or verified by the Agency or any other authority. The content is subject to change without prior notice.
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