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Diss Factsheets
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EC number: 205-358-3 | CAS number: 139-33-3
- 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
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Acute Toxicity: inhalation
Administrative data
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- experimental study
- Adequacy of study:
- key study
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Cross-reference
- Reason / purpose for cross-reference:
- reference to same study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- other: OECD Guideline 412 (Repeated Dose Inhalation Toxicity: 28/14-Day)
- Deviations:
- yes
- Remarks:
- Dosing until day 5 only
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- other: subacute
- Limit test:
- yes
Test material
- Reference substance name:
- Disodium dihydrogen ethylenediaminetetraacetate
- EC Number:
- 205-358-3
- EC Name:
- Disodium dihydrogen ethylenediaminetetraacetate
- Cas Number:
- 139-33-3
- Molecular formula:
- C10H14N2Na2O8
- IUPAC Name:
- disodium dihydrogen 2,2',2'',2'''-(ethane-1,2-diyldinitrilo)tetraacetate
- Test material form:
- solid
Constituent 1
- Specific details on test material used for the study:
- SOURCE OF TEST MATERIAL
- Batch No. of test material: 06088797V0
STABILITY AND STORAGE CONDITIONS OF TEST MATERIAL
- Expiry date: 1 September 2011
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male
- Details on test animals or test system and environmental conditions:
- Age: 7 weeks (approx.)
Identification: Tattooing of ears
All animals free of disease and clinical signs
Rats housed together (5 animals per cage) in Polysulfon cages
Bedding: Type Lignocel fibres, dust free bedding
Wooden gnawing blocks for enrichment
Rooms: Fully ariconditioned, temperature range 20 to 24 degrees celcius, 30 to 70 % humidity
Light/dark cycle of 12 hours (6 am to 6 pm light, 6 pm to 6 am dark)
Food, drinking water and bedding/enrichment materials were analysed for chemical and microbiological contaminants.
Administration / exposure
- Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose/head only
- Vehicle:
- air
- Details on inhalation exposure:
- A dust aerosol was generated using a dust generator and compressed air inside a mixing stage mixed with conditioned dilution air and passed into the inhalation system. The test substance was mixed with Aerosil R972 prior to facilitate aerosol generation.
- Analytical verification of test atmosphere concentrations:
- yes
- Remarks:
- Concentrations of the inhalation atmospheres were analyzed using gravimetry. Daily means were calculated based on 2 measured samples per concentration and exposure. From the Daily mean values of each concentration, mean concentrations and standard deviati
- Duration of exposure:
- 6 h
- Remarks on duration:
- per day, 5 consecutive days
- Concentrations:
- - 30, 300, 1000 mg/m³ (nominal conc. of Na2H2EDTA)
- 33.3 (± 2.3), 320 (± 27), 1103 (± 52) mg/m³ (measured (with SD) referring to test substance Na2H2EDTA × 2 H2O) - No. of animals per sex per dose:
- 10 animals per dose group
An additional 10 animals for the high dose group and control - Control animals:
- yes
- Details on study design:
- The animals were exposed to a respirable dust aerosol for 6 hours per day for 5 consecutive days. The exception was the high dose group (1000 mg/m³) where exposure was for one day only due to mortality observed.
- Statistics:
- Body weight/body weight change, food consumption - comparison of each group with control using DUNNETTS test (two-sided) for the hypothesis of equal means
Clinical pathology, urine volumes, urine specific gravity, Weight parameters - Non-parametric one-way analysis using Kruskal-wallis test (two sided). If resulting p-value was less than 0.05, a pairwise comparison of each dose group with the control group was performed using Wilcoxon-test (two sided) for equal means.
Results and discussion
Effect levels
- Key result
- Sex:
- male
- Dose descriptor:
- other: LOAEC
- Effect level:
- ca. 30 mg/m³ air
- Based on:
- act. ingr.
- Remarks:
- Na2H2EDTA
- Remarks on result:
- other: Basis for effect level: histopathology of the respiratory tract and lung weights
- Mortality:
- 6 deaths in the high dose group on days 0 and 1. Accelerated respiration, respiration sounds, piloerection, red encrusted nose, hunched position; Mid dose group - accelerated respiration, respiration sounds, piloerection, reduced fur care
- Clinical signs:
- other: 6 deaths in the high dose group on days 0 and 1. Accelerated respiration, respiration sounds, piloerection, red encrusted nose, hunched position; Mid dose group - accelerated respiration, respiration sounds, piloerection, reduced fur care
- Body weight:
- Decreased bodyweight change in mid and high dose group
- Gross pathology:
- Congestion, edema and multifocal hemorraghes in lungs of high dose group
- Other findings:
- FOOD CONSUMPTION
- decreased food consumption between days 0 and 1 in mid and high dose group
ORGAN WEIGHTS
- Lung weight increase in low and mid dose group
Any other information on results incl. tables
DETAILS ON RESULTS
Histopathology results:
High dose: Multifocal hemorraghes in the lungs; Inflammatory cell infiltrates
Mid dose:
Larynx: laryngeal, epithelial necrosis, multifocal, in various levels of the larynx
Inflammatory cell infiltrates in various levels of the larynx
laryngeal squamous metaplasia, multifocal, in various levels of the larynx
Regenerative hyperplasia of the laryngeal epithelium, multifocal, in various levels of the larynx
Lungs: Regenerative hyperplasia of bronchiolar epithelium (predominantly: medium bronchi, terminal bronchioles)
Mucous cell hyperplasia in large bronchi
interstitial infiltration of eosinophylic granulocytic cells
Low dose:
Larynx: Laryngeal, epithelial necrosis, multifocal, at the base of the epiglittis (level 1)
Inflammatory cell infiltrates at the base of the epiglottis (level 1)
Lungs: Regenerative hyperplasia of the bronchiolar epithelium (predominantly medium bronchi and terminal bronchioles)
Mucous cell hyperplasia in large bronchi
interstitial infiltration of eosinophylic granulocytic cells.
There were no histopathological findings in any of the recovery group animals. Thus all pathology was reversible within the recovery period.
Applicant's summary and conclusion
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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