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EC number: 203-039-3 | CAS number: 102-54-5
- 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
Genetic toxicity: in vivo
Administrative data
- Endpoint:
- in vivo mammalian somatic cell study: cytogenicity / erythrocyte micronucleus
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- September 1987 (no further details given)
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- guideline study with acceptable restrictions
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 987
- Report date:
- 1987
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.12 (Mutagenicity - In Vivo Mammalian Erythrocyte Micronucleus Test)
- Deviations:
- no
- GLP compliance:
- not specified
- Type of assay:
- micronucleus assay
Test material
- Reference substance name:
- Ferrocene
- EC Number:
- 203-039-3
- EC Name:
- Ferrocene
- Cas Number:
- 102-54-5
- Molecular formula:
- C10H10Fe
- IUPAC Name:
- iron(2+) dicyclopenta-2,4-dienide
- Details on test material:
- - Name of test material (as cited in study report): Ferrocene
- Substance type: technical product
- Physical state: red-brown solid
- Analytical purity: no data
- Impurities (identity and concentrations): no data
- Composition of test material, percentage of components: C10-H10-Fe
- Isomers composition: no data
- Purity test date: no data
- Lot/batch No.: no data
- Expiration date of the lot/batch: no data
- Stability under test conditions: no data
- Storage condition of test material: no data
Constituent 1
Test animals
- Species:
- mouse
- Strain:
- NMRI
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Winkelmann Co. Versuchstierzucht GmbH & Co. KG, 4799 Borchem/Kreis Paderborn
- Age at study initiation: about 10 weeks
- Weight at study initiation: 28 g (males); 25 g (females)
- Assigned to test groups randomly: no data
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): 3 g/day of maintenance feed for rats and mice
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 25
- Humidity (%): no data
- Air changes (per hr): "continuous air circulation"
- Photoperiod (hrs dark / hrs light): no data
IN-LIFE DATES: From: no data
Administration / exposure
- Route of administration:
- other: gavage or in feed
- Vehicle:
- - Vehicle(s)/solvent(s) used: maize germ oil
- Justification for choice of solvent/vehicle: commonly used vehicle in animal studies
- Concentration of test material in vehicle: 70 mg/5 ml vehicle
- Amount of vehicle (if gavage or dermal): 0.2 ml
- Lot/batch no. (if required): no data
- Purity: no data - Details on exposure:
- PREPARATION OF DOSING SOLUTIONS: calculated from body weight to give a dose of 100 mg/kg bw
- Duration of treatment / exposure:
- Single exposure then sampled at 24, 48 and 72 hours
- Frequency of treatment:
- once
- Post exposure period:
- 24, 48 and 72 h
Doses / concentrations
- Remarks:
- Doses / Concentrations:
100 mg/kg bw
Basis:
actual ingested
(given by gavage)
- No. of animals per sex per dose:
- 5/sex
- Control animals:
- yes, concurrent no treatment
- Positive control(s):
- Endoxane (cyclophosphamide)
- Justification for choice of positive control(s): frequently used in the test laboratory
- Route of administration: gavage
- Doses / concentrations: 100 and 250 mg/kg bw
Examinations
- Tissues and cell types examined:
- Bone marrow erythrocytes
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: maximum tolerated dose
TREATMENT AND SAMPLING TIMES ( in addition to information in specific fields): treated by gavage with 100 mg/kg bw test substance; bone marrow cells sampled 24, 48 and 72 h later. Positive control sampled at 24 h only.
DETAILS OF SLIDE PREPARATION: bone marrow suspension in 2 ml fetal calf serum centrifuged, 1.8 ml of the serum was discarded and the pellet resuspended in the remaining serum. 5 ul was applied to slides and smears pepared using an automatic smear device. The smers were air-dried for 24 h before staining with May-Grunwald and Giemsa.
METHOD OF ANALYSIS: smears were microscopically examined and the number of micronuclei per 1000 polychromatic erythrocytes were recorded. The ratio of monochromatic to polychromatic erythrocytes was determined for 1000 erythrocytes. - Evaluation criteria:
- no data
- Statistics:
- no data
Results and discussion
Test results
- Sex:
- male/female
- Genotoxicity:
- negative
- Toxicity:
- no effects
- Vehicle controls validity:
- not specified
- Negative controls validity:
- valid
- Positive controls validity:
- valid
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results: negative
In a reliable study, ferrocene exhibited no potential to induce micronuclei in the bone marrow of mice (5/sex) at the maximum tolerated dose of 100 mg/kg bw (given as a single dose by gavage) in an in vivo mammalian micronucleus assay. - Executive summary:
In a reliable study, ferrocene was assessed for its ability to induce chromosome damage in an in vivo bone marrow micronucleus assay in mice, carried out in accordance with EU test method B.12.
Groups of five mice of each sex were gavaged with 100 mg/kg bw of the test substance and the bone marrow was sampled 24, 48 and 72 h later. After concentrating the cells by centrifugation, smears were prepared on glass slides, stained and scored for micronuclei. The number of micronuclei per 1000 polychromatic erythrocytes was recorded and the ratio of monochromatic to polychromatic erythrocytes was calculated.
There was no increase in micronuclei frequency in either male or female mice when compared to the control animals. The positive control gave the expected result, confirming the sensitivity of the assay.
In a reliable study, ferrocene exhibited no potential to induce micronuclei at the maximum tolerated dose of 100 mg/kg bw in an in vivo bone marrow micronucleus assay in mice.
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