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EC number: - | 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
![](https://echa.europa.eu/o/diss-blank-theme/images/factsheets/A-REACH/factsheet/print_toxicological-information.png)
Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Study period:
- 1994-01-20 to 1994-02-24
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 1 993
- Report date:
- 1994
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Version / remarks:
- 1981
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Details on test material:
- - Test article: CGA 65047 SG 100, (A-5787 A); identical to FeNaEDDHA
- Additional specification: Sequestrene 138 Fe 100 SG
- Physical state: granules; miscible in water
- Analytical purity: 100% (UVCB)
- Lot/batch No.: P.201845
- Storage condition of test material: room temperature
Constituent 1
Test animals
- Species:
- rat
- Strain:
- other: Tif: RAI f (SPF) hybrids of RII/1 and RII/2
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: CIBA-GEIGY Limited, Aimal Production, 4332 Stein/ Switzerland
- Age at study initiation: Young adult
- Weight at study initiation: 191 to 231 g
- Fasting period before study: prior to dosing, the animals were fasted overnight
- Housing: The animal were housed in Macrolon cages type 4, with standardized soft wood bedding; the animals, segregated by sex, were group-housed (5 animals per cage)
- Diet (e.g. ad libitum): Rat diet (NAFAG 890 Tox, NAFAG, Gossau /SG, Switzerland, ad libitum
- Water (e.g. ad libitum): ad libitum
- Acclimation period: at least 5 days before administration
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22 ± 3 degree C
- Humidity (%): 55 ± 10 %
- Air changes (per hr): approximately 15 air changes per hour
- Photoperiod (hrs dark / hrs light): 12 hour/day light cycle
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- air
- Mass median aerodynamic diameter (MMAD):
- >= 1.75 - <= 2.35 µm
- Geometric standard deviation (GSD):
- >= 2.04 - <= 2.34
- Details on inhalation exposure:
- GENERATION OF TEST ATMOSPHERE / CHAMBER DESCRIPTION
- Exposure apparatus: nose only exposure system developed by Battelle Reasarch Centre (Geneva/Switzerland) and built from stainless steel by Ciba-Geigy Engineering Dept.
- Exposure chamber volume: internal active volume less than one liter
- Method of holding animals in test chamber: The rats were placed in Macrolon animal holders (Battelle Research Centres, Geneva/Switzerland) positioned radially around the exposure chamber, so that only the snouts and nostrils of the animals were exposed to the aerosol.
- Source and rate of air: The low in any individual aerosol delivery tube was standardized to 2 L/min (velocity 1.25 m/s)
- System of generating particulates/aerosols: the aerosol was generated from the solid test material by means of a brush-feed micronising jet mill. The aerosol generation system consists of a dual flexible-brush dust-feed mechanism, modified from a design by Milliman, and jet mill, redesigned from a commercial Trost Jet Mill, to be aerodynamically compatible with the brush feed and the exposure system.
- Method of particle size determination: Particle size analysis was conducted using an eight-stage cascade impactor, equiped with collection substrates punched from regenerated cellulose filters by Schleicher u. Schuell AG. Samples of 1 liter were passed through the impactor. The amount of particles in the eight size classes was determined gravimetrically.
- Treatment of exhaust air: In order to avoid rebreathing of the exhaled air, "fresh" test substance (in first-pass chamber air) was supplied to each animal via individual delivery and exhaust tubes. In addition to the necessary animal and sampling ports, identical "void" outlets were opened in proportion to the total air flow through the chamber. The exhaust air was decontaminated by subsequent passage through a Pall HDC absolute filter.
TEST ATMOSPHERE (if not tabulated)
- Particle size distribution: The continuity of the particle size distribution was verified by repeated analysis of the aerosol using an APS-33 Aerodynamic Particle Sizer, equipped with appropriate dilution system to avoid coincidence counts. The number distribution in 48 classes was converted to a mass distribution, based on the bulk density of the test substance, which was determined separately. - Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- The continuity of the particle size distribution was verified by repeated analysis of the aerosol using an APS-33 Aerodynamic Particle Sizer, equipped with appropriate dilution systems to avoid coincidence counts.
- Duration of exposure:
- 4 h
- Concentrations:
- 4202 ± 188 mg/m3 air
- No. of animals per sex per dose:
- 5
- Control animals:
- yes
- Details on study design:
- - Duration of observation period following administration: 14 days
Frequency of observations and weighing:
- clicnical symptoms and mortalities: during and after the exposure, as well as daily thereafter for 14 days
- body weight: immediately prior to exposure and on days 7 and 14 of the observation period
- Necropsy of survivors performed: yes - Statistics:
- Not performed
Results and discussion
Effect levels
- Key result
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 4 200 mg/m³ air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Mortality:
- No mortalities occured upon exposure to the test item at a concentration of 4202 ± 188 mg/m3.
- Clinical signs:
- other: The animals of both sexes exposed to the test article experienced the symptoms piloerection and dyspnea to a similar extent. They recovered within 5 days.
- Body weight:
- The weight development of all animals was within normal limits.
- Gross pathology:
- No deviations from normal morphology could be detected in all animals.
Any other information on results incl. tables
No other information
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The LC50 for acute inhalation toxicity of FeNa-EDDHA in albino rats was found to be greater than 4200 mg/m3 air.
- Executive summary:
The acute inhalation toxicity of FeNa-EDDHA in albino rats was determined according to the OECD Guideline 403 (Acute Inhalation Toxicity). Upon a four-hour acute inhalation exposure and a 14-days post-treatment observation period, no mortalities were elicited by the test item at a concentration of 4202 ± 188 mg/m3. Due to the properties of the test material, it was not possible to generate higher test article concentrations by means of standard aerosol generation equipment. The exposure to the maximum attainable concentration was thus considered a limit test as stated in the OECD test guideline 403. From the absence of mortalities it can be assumed that the LC50 to both sexes is greater than 4200 mg/m3 air.
The animals of both sexes exposed to the test article experienced the symptoms piloerection and dyspnea to a similar extent. They recovered within 5 days. At autopsy, no deviations from normal morphology could be detected in all animals.
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.
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