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Diss Factsheets
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EC number: 237-864-5 | CAS number: 14025-15-1
- 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: dermal
Administrative data
- Endpoint:
- acute toxicity: dermal
- Type of information:
- read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- supporting study
- Study period:
- June 2010
- Reliability:
- 1 (reliable without restriction)
- Rationale for reliability incl. deficiencies:
- guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 010
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
Test material
- Reference substance name:
- Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']hydroxyferrate(2-)
- EC Number:
- 270-232-7
- EC Name:
- Diammonium [[N,N'-ethylenebis[N-(carboxymethyl)glycinato]](4-)-N,N',O,O',ON,ON']hydroxyferrate(2-)
- Cas Number:
- 68413-60-5
- Molecular formula:
- C10H21N4O9Fe
- IUPAC Name:
- Ferrate(2-), [[N,N'-1,2-ethanediylbis[N-[(carboxy-kO)methyl]glycinato-kN,kO]](4-)]hydroxy-, ammonium (1:2), (PB-7-11'-121'3'3)
- Details on test material:
- Description: Red-brown liquid
Batch: 502H0003
Purity: 52.5%
Free EDTA: 2.1%
Ferrous content: 0.07%
Balance: water
Test substance storage: in refrigerator (2-8°C) protected from light
Stability under storage conditions: stable
Expiry date: 01 February 2011
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Wistar
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Deutschland, Sulzfeld, Germany
- Age at study initiation: ca. 10 weeks old
- Weight at study initiation:
- Fasting period before study: not needed
- Housing: individually (group housed during acclimation)
- Diet (e.g. ad libitum): ad lib
- Water (e.g. ad libitum): ad lib
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 19.7 – 21.5
- Humidity (%): 38-75
- Air changes (per hr): ca. 15
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From 1 to 16 June 2010
Administration / exposure
- Type of coverage:
- occlusive
- Vehicle:
- unchanged (no vehicle)
- Details on dermal exposure:
- Method: dermal application.
Clipping: one day before exposure (Day -1) an area of approximately 5x7 cm on the back of the animal was clipped.
Application: the test substance was applied in an area of approx. 10% of the total body surface, i.e. approx. 25 cm² for males and 18 cm² for females. The test substance was held in contact with the skin with a dressing, consisting of a surgical gauze patch (Surgy 1D), successively covered with aluminum foil and Coban elastic bandage. A piece of Micropore tape was additionally used for fixation of the bandages in females only.
Frequency: single dosage, on Day 1.
Dose level (volume): 2000 mg/kg body weight, dose volume calculated as dose level (g/kg) / density (g/mL).
Application period: 24 hours, after which dressings were removed and the skin cleaned of residual test substance using tap water. - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg w
- No. of animals per sex per dose:
- 5
- Control animals:
- not required
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: mortality twice daily, body weights on Days 1 (pre-administration), 8 and 15, clinical signs at periodic intervals on the day of dosing (Day 1) and once daily thereafter, until Day 15.
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight,organ weights, histopathology, other: no - Statistics:
- not required in a limit test
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Mortality:
- None
- Clinical signs:
- other: Chromodacryorrhoea was noted in two males and one female on Day 1 or 2. In two females hunched posture (Day 1) or piloerection (Day 6) were noted. Scabs were seen in the treated skin-area or in general of one male and three females during the observation
- Gross pathology:
- No abnormalities were found at macroscopic post mortem examination.
- Other findings:
- No
Applicant's summary and conclusion
- Interpretation of results:
- GHS criteria not met
- Conclusions:
- The dermal LD50 was in excess of 2000 mg/kg bw
- Executive summary:
The study was carried out based on the guidelines described in:
- OECD No.402 (1987) "Acute Dermal Toxicity"
- Commission Regulation (EC) No 440/2008, B3: "Acute Toxicity (Dermal)"
- EPA, OPPTS 870.1200 (1998), "Acute Dermal Toxicity"
- JMAFF Guidelines (2000), including the most recent revisions.
EDTA-Fe(NH4)NH4OH was administered to five Wistar rats of each sex by a single dermal occlusive application at 2000 mg/kg body weight for 24 hours. Animals were subjected to daily observations and weekly determination of body weight. Macroscopic examination was performed after terminal sacrifice (Day 15). No mortality occurred. Chromodacryorrhoea was noted in two males and one female on Day 1 or 2. In single females hunched posture (Day 1) or piloerection (Day 6) were noted. Scabs were seen in the treated skin-area of one male and three females during the observation period. Body weight gain in males and females was within the range expected for rats of this strain and age used in this type of study. No abnormalities were found at macroscopic post mortem examination of the animals. The dermal LD50 value of EDTA-Fe(NH4)NH4OH in Wistar rats was established to exceed 2000 mg/kg body weight.
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