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EC number: 247-304-1 | CAS number: 25869-00-5
- 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
- Study period:
- 20 Jul 2010 - 04 May 2011
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study.
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Report date:
- 2011
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 429 (Skin Sensitisation: Local Lymph Node Assay)
- Version / remarks:
- adopted in 2002
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Remarks:
- Országos Gyógyszerészeti Intézet, National Institute of Pharmacy, Budapest, Hungary
- Type of study:
- mouse local lymph node assay (LLNA)
Test material
- Reference substance name:
- Ammonium iron(3+) hexakis(cyano-C)ferrate(4-)
- EC Number:
- 247-304-1
- EC Name:
- Ammonium iron(3+) hexakis(cyano-C)ferrate(4-)
- Cas Number:
- 25869-00-5
- Molecular formula:
- C6FeN6.Fe.H4N
- IUPAC Name:
- ammonium iron(3+) hexakis(cyano-C)ferrate(4-)
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): ammonium iron(3+) hexakis(cyano-C) ferrate(4-)
- Physical state: solid
- Appearance: blue odourless powder
- Analytical purity: 93.6%
- Lot/batch No.: K73-4766
- Expiration date of the lot/batch: 20 Mar 2013
- Storage condition of test material: at room temperature in the dark
Constituent 1
In vivo test system
Test animals
- Species:
- mouse
- Strain:
- other: CBA/J Rj
- Sex:
- female
- Details on test animals and environmental conditions:
- TEST ANIMALS
- Source: Elevage Janvier, Le Genest-Saint-Isle, France
- Age at study initiation: 10 - 11 weeks
- Weight at study initiation: 21.1 - 24.5 g
- Housing: Mice were housed individually in type II polypropylene/polycarbonate cages with Lignocel® Hygienic Animal Bedding and glass tunnel-tubes.
- Diet: ssniff SM R/M-Z+H "Autoclavable complete diet for rats and mice – breeding and maintenance", Soest, Germany, ad libitum
- Water: tap water, ad libitum
- Acclimation period: 20 d
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3
- Humidity (%): 30 - 70
- Air changes (per hr): 15 - 20
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES:
From: 22 Sep 2010
To: 28 Sep 2010
Study design: in vivo (LLNA)
- Vehicle:
- dimethylformamide
- Concentration:
- 10, 25 and 50% (w/v)
- No. of animals per dose:
- 4
- Details on study design:
- RANGE FINDING TESTS:
The preliminary experiment was conducted in a similar experimental manner to the main study, but it was terminated on Day 6 and radioactive proliferation assay was not performed. Two animals per dose group were used.
- Compound solubility: The maximum soluble concentration was > 50% (w/v) test substance in the vehicle. For the preliminary irritation test, concentrations of 25 and 50% (w/v) of the test substance in dimethylformamide (DMF) were used. In both concentrations, the test substance precipitated on the ears of the treated animals.
- Irritation: No skin irritation and no systemic toxicity were observed during the treatment period.
- Lymph node proliferation response: not performed
MAIN STUDY
ANIMAL ASSIGNMENT AND TREATMENT
- Name of test method: Tritiated thymidine (³HTdR) incorporation determined by β-scintillation.
- Criteria used to consider a positive response:
The test item is regarded as a sensitizer if both of the following criteria are fulfilled:
1. Exposure to at least one concentration of the test substance resulted in an incorporation of ³HTdR at least 3-fold or higher than recorded in control mice, as indicated by the stimulation index.
2. Dose-response relationship, structural relationship with known skin sensitizers as well as local skin irritation must be taken into account.
TREATMENT PREPARATION AND ADMINISTRATION:
25 μl of 10, 25 and 50% (w/v) of the test substance in DMF was applied to the entire dorsal surface of both ears of each mouse. Each animal was treated once a day for 3 consecutive days. There was no treatment on Days 4 and 5. On Day 6, an injection of 250 μl phosphate buffered saline (PBS) containing 20 μCi of ³HTdR was made into the tail vein of each animal. Approximately 5 h later, the draining auricular lymph node of each ear was excised into PBS. Once removed, the nodes of mice from each test group were pooled. A single cell suspension of these pooled lymph node cells was prepared by gentle mechanical disaggregating of the lymph nodes through a cell strainer using the plunger of a disposable syringe. Single cell suspensions were washed two-fold with PBS. After washing, cells were precipitated with 5% trichloroacetic acid (TCA) at 2 - 8 °C for 18 h. Each precipitate was transferred to a suitable sized scintillation vial with 10 mL of scintillation liquid and thoroughly mixed. The vials were loaded to a β-scintillation counter and ³HTdR incorporation was measured for up to 10 min per sample. - Positive control substance(s):
- other: 25% (w/v) α-hexylcinnamaldehyde in dimethylformamide (DMF)
Results and discussion
- Positive control results:
- The positive control substance induced a SI value of 3.8, thus meeting the reliability criteria for the local lymph node assay (SI > 3).
In vivo (LLNA)
Resultsopen allclose all
- Parameter:
- SI
- Remarks on result:
- other: negative control: SI 1 10% (w/v) test substance: SI 1.3 25% (w/v) test substance: SI 1.2 50% (w/v) test substance: SI 1.2 positive control: SI 3.8
- Parameter:
- other: disintegrations per minute (DPM)
- Remarks on result:
- other: negative control: 746.5 DPM 10% (w/v) test substance: 939.5 DPM 25% (w/v) test substance: 880.5 DPM 50% (w/v) test substance: 860.5 DPM positive control: 2807 DPM
Any other information on results incl. tables
Clinical signs:
No mortality and no signs of systemic toxicity were observed in any animal during the study period. The treatment with the test substance has no influence on the body weight of the animals.
Table 1: Results of the local lymph node assay in mice.
Test group |
DPM/group |
corrected DPM/group |
DPN |
No. of nodes |
SI values |
Background (5% (w/v) TCA) |
35.5 |
--- |
--- |
|
--- |
Negative control |
782 |
746.5 |
93.3 |
8 |
1.0 |
10% (w/v) test substance |
975 |
939.5 |
117.4 |
8 |
1.3 |
25% (w/v) test substance |
916 |
880.5 |
110.1 |
8 |
1.2 |
50% (w/v) test substance |
896 |
860.5 |
107.6 |
8 |
1.2 |
positive control |
2807* |
2807* |
350.9 |
8 |
3.8 |
* In the study report, there was no difference of the positive control DPM value before and after the correction regarding the background value.
DPM: Disintegrations per minute
DPN: DPM divided by the number of lymph nodes
SI: Stimulation index
Applicant's summary and conclusion
- Interpretation of results:
- not sensitising
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- CLP: not classified
DSD: not classified
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