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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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: 235-649-0 | CAS number: 12410-14-9
- 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
Repeated dose toxicity: inhalation
Administrative data
- Endpoint:
- short-term repeated dose toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: non-GLP, no guideline provided
Data source
Referenceopen allclose all
- Reference Type:
- publication
- Title:
- Macrophage Reaction in Rabbit Lung following Inhalation of Iron Chloride.
- Author:
- Johansson A, Curstedt T, Rasool O, Jarstrand C, Camner P
- Year:
- 1 992
- Bibliographic source:
- DOI 10.1016/S0013-9351(05)80205-1 PMID 1597169 Environmental Research 58(1-2):66-79.
- Reference Type:
- secondary source
- Title:
- Unnamed
- Year:
- 2 004
- Report date:
- 2004
Materials and methods
Test guideline
- Qualifier:
- no guideline available
- Principles of method if other than guideline:
- Inhalation study of 60 days, MMAD: 1 µm, exposure frequency 5 days/week, 6 hours/day, 2 dose groups + control, 8 male rabbits/group.
- GLP compliance:
- no
- Limit test:
- no
Test material
- Reference substance name:
- Iron trichloride
- EC Number:
- 231-729-4
- EC Name:
- Iron trichloride
- Cas Number:
- 7705-08-0
- IUPAC Name:
- iron(3+) trichloride
- Reference substance name:
- Ferric chloride
- IUPAC Name:
- Ferric chloride
- Details on test material:
- - Name of test material (as cited in study report): Iron chloride
- Molecular formula: FeCl3
Constituent 1
Constituent 2
Test animals
- Species:
- rabbit
- Strain:
- not specified
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: no data
- Age at study initiation: no data
- Weight at study initiation: 2.8±0.5 kg
- Fasting period before study: no data
- Housing: no data
- Diet (e.g. ad libitum): no data
- Water (e.g. ad libitum): no data
- Acclimation period: no data
ENVIRONMENTAL CONDITIONS
- Temperature (°C): no data
- Humidity (%): no data
- Air changes (per hr): no data
- Photoperiod (hrs dark / hrs light): no data
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- not specified
- Vehicle:
- air
- Remarks on MMAD:
- MMAD / GSD: 1 µm
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- System of generating particulates/aerosols: ultrasonic nebulizer (De Vilbiss 35B)
- Method of particle size determination: impactor (Mitchell and Pilcher, 1959)
TEST ATMOSPHERE
- Brief description of analytical method used: Metal concentration was estimated by sucking air through a filter (Satorius, 100 N, pore size 0.8 µm) and by analyzing the metal deposited on the filter with atomic absorption spectrophotometry (Varian AA6)
- Samples taken from breathing zone: yes - Analytical verification of doses or concentrations:
- yes
- Details on analytical verification of doses or concentrations:
- Metal concentration was estimated by sucking air through a filter (Satorius, 100 N, pore size 0.8 µm) and by analyzing the metal deposited on the filter with atomic absorption spectrophotometry (Varian AA6)
- Duration of treatment / exposure:
- 2 months
- Frequency of treatment:
- 5 days/week, 6 hours/day
Doses / concentrations
- Remarks:
- Doses / Concentrations:
1.4±0.7, 3.1±1.8 mg/m3
Basis:
no data
- No. of animals per sex per dose:
- 8
- Control animals:
- yes, concurrent vehicle
- Details on study design:
- - Dose selection rationale: no data
- Rationale for animal assignment (if not random): no data
- Section schedule rationale (if not random): no data
Examinations
- Observations and examinations performed and frequency:
- CAGE SIDE OBSERVATIONS: No data
DETAILED CLINICAL OBSERVATIONS: No data
BODY WEIGHT: No data
FOOD CONSUMPTION:
- Food consumption for each animal determined and mean daily diet consumption calculated as g food/kg body weight/day: No data
FOOD EFFICIENCY:
- Body weight gain in kg/food consumption in kg per unit time X 100 calculated as time-weighted averages from the consumption and body weight gain data: No data
WATER CONSUMPTION: No data
OPHTHALMOSCOPIC EXAMINATION: No data
HAEMATOLOGY: No data
CLINICAL CHEMISTRY: No data
URINALYSIS: No data
NEUROBEHAVIOURAL EXAMINATION: No data
OTHER:
Lung tissue analysis: gross data, histological data, ultrastructural data
Alveolar macrophages: light microscopic data, ultrastructural data, scanning electron microscopic data, functional data, phospholipid data - Sacrifice and pathology:
- GROSS PATHOLOGY: Yes
HISTOPATHOLOGY: Yes - Statistics:
- Morphological data were evaluated with the Mann-Whitney U test and data on phospholipids and lung weights were evaluated with the t test. Level of significance was 0.05, two-tailed test.
Results and discussion
Results of examinations
- Clinical signs:
- not specified
- Mortality:
- not specified
- Body weight and weight changes:
- not specified
- Food consumption and compound intake (if feeding study):
- not specified
- Food efficiency:
- not specified
- Water consumption and compound intake (if drinking water study):
- not specified
- Ophthalmological findings:
- not specified
- Haematological findings:
- not specified
- Clinical biochemistry findings:
- not specified
- Urinalysis findings:
- not specified
- Behaviour (functional findings):
- not specified
- Organ weight findings including organ / body weight ratios:
- effects observed, treatment-related
- Description (incidence and severity):
- The lung weight, expressed as the weight (mean±SD) of the left lower lobe, was 1.9±0.4 in the control group, 2.0±0.7 in the low-Fe group, 2.3±0.3 in the high-Fe group.
- Gross pathological findings:
- effects observed, treatment-related
- Description (incidence and severity):
- 7 of the 8 rabbits in the high-Fe group, 2 in the low-Fe group, and none of the controls had black-spotted lungs.
- Histopathological findings: non-neoplastic:
- effects observed, treatment-related
- Description (incidence and severity):
- Foci of interstitial inflamatory reaction, involving mostly lymphocytes in the high-Fe group. Accumulation of normal as well as granular macrophages in alveoli of rabbits: both exposed groups.
- Histopathological findings: neoplastic:
- not specified
- Details on results:
- CLINICAL SIGNS AND MORTALITY
no data
BODY WEIGHT AND WEIGHT GAIN
no data
FOOD CONSUMPTION
no data
FOOD EFFICIENCY
no data
WATER CONSUMPTION
no data
OPHTHALMOSCOPIC EXAMINATION
no data
HAEMATOLOGY
no data
CLINICAL CHEMISTRY
no data
URINALYSIS
no data
NEUROBEHAVIOUR
no data
ORGAN WEIGHTS
The lung weight, expressed as the weight (mean±SD) of the left lower lobe, was 1.9±0.4 in the control group, 2.0±0.7 in the low-Fe group, 2.3±0.3 in the high-Fe group.
GROSS PATHOLOGY
7 of the 8 rabbits in the high-Fe group, 2 in the low-Fe group, and none of the controls had black-spotted lungs.
HISTOPATHOLOGY: NON-NEOPLASTIC
Foci of interstitial inflamatory reaction, involving mostly lymphocytes in the high-Fe group. Accumulation of normal as well as granular macrophages in alveoli of rabbits: both exposed groups. The control rabbits showed essentially normal lung tissue with some small accumulations of macrophages and occasional small inflamatory reactions.
OTHER FINDINGS
Ultrastructural data: Volume density of the alveolar type II cells was measured in the control group and in the high-Fe group. The value of the high-Fe group, 0.061±0.018 (mean±SD), was significantly higher than that of the control group, 0.045±0.012 (P<0.05).
Alveolar macrophages
Light microscopic data: Significantly more macrophages were obtained by lavage from both Fe groups than from the controls. The number was significantly higher in the high- than in the low-Fe group.
Ultrastructural data: The most characteristic findings were enlarged lysosomal complexes in macrophages from Fe-exposed rabbits. The percentage of cells with a surface lacking protrusions (smooth surface) in the high-Fe group was also higher than in the controls.
Phospholipid data: The concentration of total phospholipids was significantly increased in the high-Fe group compared to controls as well as to the low-dose group.
Effect levels
- Dose descriptor:
- LOAEL
- Effect level:
- 1.4 mg/m³ air (analytical)
- Based on:
- element
- Remarks:
- Fe
- Sex:
- male
- Basis for effect level:
- other: overall effects basing on gross pathology; organ weights; histopathology / the Health Council of the Netherlands Committee on Updating of Occupational Exposure Limits conclude on an OEL = 0.1 mg/m³.
Target system / organ toxicity
- Critical effects observed:
- not specified
Applicant's summary and conclusion
- Conclusions:
- The Committee on Updating of Occupational Exposure Limits of the Health Council of the Netherlands concludes that the lowest-observed-adverse-effect level (LOAEL) from this study is 1.4 mg Fe/m3, as respirable aerosols/particles, for effects on the lungs of rabbits after subacute inhalation exposure.
- Executive summary:
The purpose of the present non-GLP and not conforme to OECD guideline study was to investigate the effects of inhaled FeCl3 on rabbit lung with special reference to alveolar macrophages, alveolar epithelial cells, and surfactant in order to have a basis for designing combined inhalation studies with iron and other metals and to investigate whether potentiations occur.
Groups of eight rabbits were inhalation-exposed to iron, 1.4±0.7 mg/m³ (low Fe), or 3.1±1.8 mg/m³ (high Fe) as FeCl3 or to filtered air (controls) for 2 months, 5 days/week and 6 hours/day. The alveolar macrophages were increased in number in both exposed groups. Noduli of granular macrophages were found in lungs of all the rabbits in the high-Fe group, in one from the low-Fe group, and in one control rabbit. Especially in the high-Fe group there were prominent changes in the macrophages such as enlarged lysosomes containing fibrous-looking structures, iron-rich inclusions, and densely packed, 5 -nm electron-dense granules. The number of cells filled with surfactant-like inclusions as well as smooth surface was inceased in the high-Fe group and the macrophages had enhanced phagocytic capacity. There was an increase in the phospholipid concentration and in the volume density of type II cells in the high-Fe group but the level of phosphatidylcholines was not significantly changed. The fact that Fe(3 +) affected mainly the alveolar macrophages might be due to the relatively high concentration of iron in these cells caused by the precipitation of iron in their lysosomes.
The Committee on Updating of Occupational Exposure Limits of the Health Council of the Netherlands concludes that the lowest-observed-adverse-effect level (LOAEL) from this study is 1.4 mg Fe/m³, as respirable aerosols/particles, for effects on the lungs of rabbits after subacute inhalation exposure.
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.