Registration Dossier
Registration Dossier
Data platform availability banner - registered substances factsheets
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
Diss Factsheets
Use of this information is subject to copyright laws and may require the permission of the owner of the information, as described in the ECHA Legal Notice.
EC number: 932-833-9 | 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
Genetic toxicity: in vitro
Administrative data
- Endpoint:
- in vitro gene mutation study in bacteria
- Remarks:
- Type of genotoxicity: gene mutation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Research publication. Reasonably documented meets generally accepted scientific principles, acceptable for assessment. Read-across to the registered substance is considered scientifically justified. The original study and the read-across to the registered substance are considered to be reliability 2.
Data source
Reference
- Reference Type:
- publication
- Title:
- Genotoxicity of iron compounds in Salmonella typhimurium and L5178Y mouse lymphoma cells.
- Author:
- Dunkel V C, San R H C, Seifried H E, Whittaker P
- Year:
- 1 999
- Bibliographic source:
- Environ Mol Mutagenesis 33: 28-41
Materials and methods
Test guideline
- Qualifier:
- equivalent or similar to guideline
- Guideline:
- OECD Guideline 471 (Bacterial Reverse Mutation Assay)
- Deviations:
- no
- Principles of method if other than guideline:
- Method: other: Ames (1975)
- GLP compliance:
- not specified
- Type of assay:
- bacterial reverse mutation assay
Test material
- Reference substance name:
- Ferric chloride hexahydrate
- IUPAC Name:
- Ferric chloride hexahydrate
- Reference substance name:
- 10025-77-1
- Cas Number:
- 10025-77-1
- IUPAC Name:
- 10025-77-1
- Details on test material:
- The substance tested was ferric chloride hexahydrate (CAS number 10025-77-1, FeCl3.6H2O - 100% pure ex Mallinckrodt)
Constituent 1
Constituent 2
Method
Species / strain
- Species / strain / cell type:
- S. typhimurium, other: TA97a, TA98, TA100, TA102, TA1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Metabolic activation system:
- Aroclor induced rat and hamster liver S9
- Test concentrations with justification for top dose:
- Plate incorporation assay up to 10,000 µg Fe/plate + and - S9. Pre-incubation assay
- Vehicle / solvent:
- Vehicle used: distilled water
Controlsopen allclose all
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 9-aminoacridine
- Remarks:
- TA97 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- no
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- 2-nitrofluorene
- Remarks:
- TA 98 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- sodium azide
- Remarks:
- TA 100 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- cumene hydroperoxide
- Remarks:
- TA 102 without activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA 98 and 100 with activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: sterigmatocystin
- Remarks:
- TA 102 with activation
- Untreated negative controls:
- no
- Negative solvent / vehicle controls:
- yes
- Remarks:
- distilled water
- True negative controls:
- no
- Positive controls:
- yes
- Positive control substance:
- other: 2-aminoanthracene
- Remarks:
- TA97 with activation
- Details on test system and experimental conditions:
- METHOD OF APPLICATION: in agar (plate incorporation); preincubation - in medium
DURATION
- Preincubation period: 20 min
- Exposure duration: 48 hours
- Expression time (cells in growth medium): 48 hours concurrent with exposure
SELECTION AGENT (mutation assays): minimal agar
NUMBER OF REPLICATIONS: doses were tested in triplicate in the plate incorporation assay . 10 dose levels were tested in the pre-incubation assay, and at least 5 doses in the plate incorporation assay
DETERMINATION OF CYTOTOXICITY
- Method: cytotoxicity was determined by plating 10 doses with and without activation. Criteria to evaluate toxicity are not presented.
- Evaluation criteria:
- A substance is considered positive if it shows induction of doubling of mean number of revertants in at least one tester strain, accompanied by a clear dose response. In strains TA 1537 and 1538, an increase in revertants of less than threefold will be confirmed in a repeat experiment.
- Statistics:
- Plates were counted in a MiniCount automated colony counter. The mean number of revertants of three plates was calculated.
Results and discussion
Test results
- Species / strain:
- S. typhimurium, other: TA98, TA100, TA102, TA1535, TA1537, TA1538
- Metabolic activation:
- with and without
- Genotoxicity:
- negative
- Cytotoxicity / choice of top concentrations:
- not specified
- Vehicle controls validity:
- valid
- Untreated negative controls validity:
- not applicable
- Positive controls validity:
- valid
- Remarks on result:
- other: all strains/cell types tested
- Remarks:
- Migrated from field 'Test system'.
Any other information on results incl. tables
GENOTOXIC EFFECTS:
Plate incorporation assay
- With and without metabolic activation: No increase in reverse mutation rate in any strain at dose levels up to 10,000 ug/plate (revertant
counts not
reproduced in the publication)
- Preincubation assay:
Results not presented for ferric chloride but lack of activity in this assay was demonstrated with ferrous sulphate and ferrous fumarate.
PRECIPITATION CONCENTRATION: None reported
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information):
negative with and without metabolic activation
No evidence of mutagenicity to bacteria was obtained when ferric chloride (CAS 10025-77-1 FeCl3.6H2O) was tested using the bacterial reverse mutation assay in Salmonella typhimurium strains TA97a, TA98, TA100, TA102, TA1535, TA1537, TA1538 at dose levels up to 10000 µg Fe/plate. It is concluded that ferric chloride is negative for mutagenicity to bacteria under the conditions of this test.
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.
Reproduction or further distribution of this information may be subject to copyright protection. Use of the information without obtaining the permission from the owner(s) of the respective information might violate the rights of the owner.