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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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 vivo
Administrative data
- Endpoint:
- in vivo mammalian germ cell study: cytogenicity / chromosome aberration
- Remarks:
- Type of genotoxicity: chromosome aberration
- 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: Research paper study well documented meeting generally accepted scientific principles but not a standard micronucleus test. The original study and the read-across are considered to be reliability 2.
Data source
Reference
- Reference Type:
- publication
- Title:
- Nuclear aberrations and micronuclei induction in the digestive tract of mice treated with different iron salts.
- Author:
- Bianchini F, Caderni G, Dolara P, Tanagnelli E
- Year:
- 1 988
- Bibliographic source:
- J App Tox 8(3): 179-183
Materials and methods
- Principles of method if other than guideline:
- Method: other: Bruce et al (modified); Wargovich et al, J Natl Cancer Inst 71 125-131 1983
- GLP compliance:
- not specified
- Type of assay:
- other: micronucleus assay using tissues from gastrointestinal tract
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:
- Obtained from Merck and reportedly containing ca 20% Fe.
The material tested was the hexahydrate of Ferric chloride CAS number 10025-77-1 FeCl3.6H2O
Constituent 1
Constituent 2
Test animals
- Species:
- mouse
- Strain:
- C57BL
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Calco, Como, Italy
- Age at study initiation: no data
- Weight at study initiation: 17-18 g
- Fasting period before study: 12 hours (oral administration) or not fasted (rectal administration)
- Housing: no data
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: no data
Administration / exposure
- Route of administration:
- other: oral or intrarectal
- Vehicle:
- - Vehicle(s)/solvent(s) used: physiol. saline;
- Concentration of test material in vehicle: 2, 6.5 and 13 mg Fe/kg
- Amount of vehicle (if gavage or dermal): 0.2ml - Duration of treatment / exposure:
- 24 hours
- Frequency of treatment:
- Single treatment
Doses / concentrations
- Remarks:
- Doses / Concentrations:
2, 6.5 and 13 mg Fe/kg
Basis:
- No. of animals per sex per dose:
- 4-9
- Control animals:
- yes
- Positive control(s):
- 2-amino-3-methylimidazo(4,5,f) quinoline (IQ)
- Justification for choice of positive control(s): this is a genotoxic chemical with specific intestinal action.
- Route of administration: orally to non-fasting mice
- Doses / concentrations: 100 and 200 mg/kg bw
Examinations
- Tissues and cell types examined:
- Colon, duodenum and stomach mucosal cells for oral administration, colon samples after interrectal administration.
- Details of tissue and slide preparation:
- CRITERIA FOR DOSE SELECTION: The lowest dose tested was equivalent to a therapeutic dose in iron deficiency anaemia.
DETAILS OF SLIDE PREPARATION: colon and duodenum where opened longitudinally and rolled. The forestomach was excised. Specimens were fixed in 10% buffered formalin and processed for histology. Slides with 5 micron thick paraffin sections were stained with Feulgen-fast green.
METHOD OF ANALYSIS:
Slides were examined and scored for a) micronuclei defined as nuclear fragments not larger than ¼ -1/3 of the diameter of the primary nucleus b) nuclear aberrations comprised of micronuclei, pyknotic nuclei, cytolysosomes and disintegrated nuclei. The forestomach was analysed by observing ca 400 mucosal cells per animal. Mucosal cells lining 20 crypts for colon and 5 crypts for duodenum were analysed per animal beginning from the anal end of the colon and the pyloric end of the duodenum.
OTHER:
Results and discussion
Test results
- Sex:
- female
- Genotoxicity:
- negative
- Toxicity:
- yes
- Remarks:
- dose related toxic effects were seen in colons of feeding animals and colon and stomach of fasting animals
- Vehicle controls validity:
- valid
- Negative controls validity:
- not applicable
- Positive controls validity:
- valid
Any other information on results incl. tables
The reference compound IQ caused an increase of nuclear aberrations and micronuclei, results being presented for effects in the colon.
Neither ferric chloride nor ferrous sulphate significantly increased the incidence of micronuclei in the stomach, duodenum or colon following oral
administration to fasting or non-fasting mice. Nuclear aberrations were slightly increased in the duodenum of fasting rats receiving ferric chloride but
not ferrous sulphate. In the colon nuclear aberrations were increased in fasting mice receiving oral ferric chloride and in fasting and non-fasting
mice receiving oral ferrous sulphate.
Following intrarectal administration ferric chloride showed greater toxicity to the colon than ferrous sulphate producing a slight but statistically
significant (p<0.01) increase in micronuclei. Both iron salts increased the incidence of nuclear aberrations following intrarectal administration but
this was more marked with ferric chloride.
The authors consider that the iron salts do not appear to have a significant genotoxic effect on the gastrointestinal tract and that the toxic effects are
due to generalized toxicity rather than a genotoxic effect.
Applicant's summary and conclusion
- Conclusions:
- Interpretation of results (migrated information): negative
Ferric chloride has been tested in a study to examine the incidence of micronuclei in an assay using tissues from the gastrointestinal tract. The test substance is not considered to have a significant genotoxic effect on the mouse gastrointestinal tract as measured by induction of micronuclei. An increased incidence of nuclear aberrations was considered evidence of general toxicity.
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.