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EC number: 828-479-9 | CAS number: 2088841-41-0
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Remarks:
- Type of genotoxicity: chromosome aberration
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- January-March 1992
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- other: Well performed and reported GLP study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 992
- Report date:
- 1992
Materials and methods
Test guidelineopen allclose all
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 474 (Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Qualifier:
- according to guideline
- Guideline:
- other: EPA, CFR 40, Subpart F - In vivo mammalian bone marrow cytogenetics tests: Micronucleus assay - 1 July 1986
- GLP compliance:
- yes (incl. QA statement)
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts
- EC Number:
- 283-041-9
- EC Name:
- Acetic acid, oxo-, sodium salt, reaction products with cresol and ethylenediamine, iron sodium salts
- Cas Number:
- 84539-53-7
- Molecular formula:
- non specified (UVCB substance)
- IUPAC Name:
- non specified (UVCB substance)
- Reference substance name:
- EDDHMA-Fe
- IUPAC Name:
- EDDHMA-Fe
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- Name of the test compound: FeEDDHMANa
Batch no: 74 : 18277
Appearance: dark red to brown solid
Purity of technical grade: 52-53%
Storage: at room T, light protected in closed containers
Expiry date: October 4, 1994
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Wiga GmbH, Sulzfeld, Germany
- Age at study initiation: minimally 10 weeks (at delivery)
- Weight at study initiation: ca. 30 g
- Assigned to test groups randomly: yes, under following basis: no info
- Fasting period before study: 18 h before application
- Housing: individually
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: minimally 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21±3
- Humidity (%): 30-70
- Air changes (per hr): no info
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 14 January To: 11 March 1992
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- Aqua deionized
- Vehicle; aqua deionized
- Justification for choice of solvent/vehicle: non toxic
- Concentration of test material in vehicle: 250 mg/mL
- Amount of vehicle (if gavage or dermal): 20 mL/kg - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: dissolved in deionized water
- Duration of treatment / exposure:
- single application
- Frequency of treatment:
- single application
- Post exposure period:
- 24, 48 and 72 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
5000 mg/kg bw
Basis:
actual ingested
- No. of animals per sex per dose:
- 6 (of which 5 were evaluated); the 6th animal functioned as spare animal
- Control animals:
- yes, concurrent vehicle
- Positive control(s):
- cyclophosphamide
- Justification for choice of positive control(s): no info
- Route of administration: per gavage
- Doses / concentrations: 30 mg/kg bw at 10 ml/kg bw
- Prepared on the fay of administration
Examinations
- Tissues and cell types examined:
- Bone marrow:
- per animal, 1000 PCE were analysed for micronuclei,
- ratio PCE/NCE to determine cytotoxicity - Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: limit test based on results RF test (2 males/2 females); no toxic signs were noted
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): single application, sampled at 24, 48 and 72 h after application
DETAILS OF SLIDE PREPARATION: small drop of resuspended cells was spread on a slide; stained with May-Gruenwald/Giemsa
METHOD OF ANALYSIS: 1000 PCE per animal were analysed for micronuclei.
- Evaluation criteria:
- Statistically significant increases for at least one of the test points, together with biological relevance.
- Statistics:
- Mann-Whitney test
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- valid
- Negative controls validity:
- not examined
- Positive controls validity:
- valid
- Additional information on results:
- RESULTS OF RANGE-FINDING STUDY
- Dose range: 0 and 5000 mg/kg bw
- Solubility: OK
- Clinical signs of toxicity in test animals: no
- Evidence of cytotoxicity in tissue analyzed: not done
- Rationale for exposure: no info
- Harvest times: only used for determination of toxicity
- High dose with and without activation: not applicable
RESULTS OF DEFINITIVE STUDY
- Types of structural aberrations for significant dose levels (for Cytogenetic or SCE assay): not applicable
- Induction of micronuclei (for Micronucleus assay): no increases when compared to controls
- Ratio of PCE/NCE (for Micronucleus assay): see Table below
- Appropriateness of dose levels and route: limit dose was tested
- Statistical evaluation: not needed (one dose level tested)
Any other information on results incl. tables
Micronuclei - results
Dose (mg/kg bw) |
PCEs with micronuclei (%) |
Range |
PCE/NCE |
24 h sampling time |
|||
0 |
0.10 |
0-3 |
1000/682 |
5000 |
0.13 |
0-3 |
1000/899 |
Positive control |
1.45 |
7-34 |
1000/869 |
48 h sampling time |
|||
0 |
0.12 |
0-3 |
1000/748 |
5000 |
0.10 |
0-3 |
1000/814 |
72 h sampling time |
|||
0 |
0.08 |
0-2 |
1000/719 |
5000 |
0.15 |
0-3 |
1000/728 |
Applicant's summary and conclusion
- Conclusions:
- The test article did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse.
- Executive summary:
This study was performed to investigate the potential of FeEDDHMANa to induce micronuclei in polychromatic erythrocytes (peE) in the bone marrow of the mouse. The test article was dissolved in aqua deionized. This solvent was used as negative control. The volume administered orally was
20 ml/kg bw. 24 h, 48 hand 72 h after a single application of the test article the bone marrow cells were collected for micronuclei analysis.
Ten animals (5 males, 5 females) per test group were evaluated for the occurrence of micronuclei. 1000 polychromatic erythrocytes (peE) per animal were scored for micronuclei. To describe a cytotoxic effect due to the treatment with the test article the ratio between polychromatic and normochromatic erythrocytes (NCE) was determined in the same sample and reported as the number of NCE per 1000 peE.
The following dose level of the test article was investigated: 24 h, 48 h and 72 h preparation interval: 5000 mg/kg bw.
In a pre-experiment this dose level was estimated to be the maximum attainable dose. The animals expressed no toxic reactions.
After treatment with the test article the ratio between PCEs and NCEs was not affected as compared to the corresponding" negative controls thus indicating no cytotoxic effects. In comparison to the corresponding negative controls there was no statistically significant enhancement in the frequency of the detected micronuclei at any preparation interval after application of the test article. An appropriate reference mutagen was used as positive control which showed a distinct increase of induced micronucleus frequency.
In conclusion, it can be stated that during the study described and under the experimental conditions reported, the test article did not induce micronuclei as determined by the micronucleus test with bone marrow cells of the mouse. Therefore, FeEDDHMANa is considered to be non-mutagenic in this micronucleus assay.
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