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EC number: 283-042-4 | CAS number: 84539-54-8
- 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
Acute Toxicity: oral
Administrative data
- Endpoint:
- acute toxicity: oral
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- from 2000-07- 27 to 2000-08-15
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: GLP guideline study
Data source
Reference
- Reference Type:
- study report
- Title:
- Unnamed
- Year:
- 2 000
- Report date:
- 2000
Materials and methods
Test guideline
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes
- Test type:
- acute toxic class method
- Limit test:
- yes
Test material
- Test material form:
- solid: particulate/powder
- Remarks:
- migrated information: powder
- Details on test material:
- - Name of test material (as cited in study report): EDDHAS Fe, sel de K
- Molecular formula (if other than submission substance): C18H14FeN2O12S2(3K)
- Molecular weight (if other than submission substance): 687.3
- Smiles notation (if other than submission substance): O=C(O)C(NCCNC(C(=O)O)c1cc(ccc1(O))S(=O)(=O)O)c2cc(ccc2(O))S(=O)(=O)O
- InChl (if other than submission substance): InChI=1S/C18H20N2O12S2/c21-13-3-1-9(33(27,28)29)7-11(13)15(17(23)24)19-5-6-20-16(18(25)26)12-8-10(34(30,31)32)2-4-14(12)22/h1-4,7-8,15-16,19-22H,5-6H2,(H,23,24)(H,25,26)(H,27,28,29)(H,30,31,32)
- Substance type: Fe chelate
- Physical state: brownish/red powder
- Analytical purity: 55±2%
- Impurities (identity and concentrations): none
- Purity test date: 2000-10-24
- Expiration date of the lot/batch: 2001-01-24
- Stability under test conditions: at least 6 months from receipt (date of receipt: 24 July 2000)
- Storage condition of test material: at room temperature and protected from humidity
- Other:
Constituent 1
Test animals
- Species:
- rat
- Strain:
- Sprague-Dawley
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Iffa Credo, 69210 LArbresle, France.
- Age at study initiation: 6 weeks old
- Weight at study initiation: 172 ± 4 g for the males and 139 ± 3 g for the females
- Fasting period before study: The animals were fasted for an overnight period of approximately 18 hours before dosing, but had free access to water. Food was given back approximately 4 hours after administration of the test substance.
- Housing: in polycarbonate cages with stainless steel lid (48 cm x 27 cm x 20 cm). Each cage contained one to seven animals of the same sex during the acclimation period and three rats of the same sex and group during the treatment period. Each cage contained dust-free sawdust (SICSA, 94142 Alfortville, France).
- Diet (e.g. ad libitum): ad libitum, except prior dosing (see above). A04 C pelleted diet (UAR, 91360 Villemoisson-sur-Orge, France)
- Water (e.g. ad libitum): drinking water filtered by a FG Millipore membrane (0.22 micron) was provided ad libitum.
- Acclimation period: at least 5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 21 ±2
- Humidity (%): 30 to 70
- Air changes (per hr): approximately 12 cycles/hour of filtered, non-recycled air
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 2000-07- 27 To: 2000-08-15
Administration / exposure
- Route of administration:
- oral: gavage
- Vehicle:
- water
- Remarks:
- purified (by reverse osmosis)
- Details on oral exposure:
- VEHICLE
- Concentration in vehicle: not reported: "The test substance was prepared at the chosen concentration in the vehicle. The test substance preparation was made freshly..."
- Amount of vehicle (if gavage): 10 mL/kg bw
MAXIMUM DOSE VOLUME APPLIED: "The volume administered to each animal was adjusted according to body weight determined on the day of treatment".
CLASS METHOD (if applicable)
- Rationale for the selection of the starting dose: As the test substance was anticipated to be non-toxic at 2000 mg/kg, a limit test was performed by administering 2000 mg/kg of the test substance to one group of three males. As no deaths occurred, the study was completed by the administration of the dose-level of 2000 mg/kg to one group of three females. - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 3
- Control animals:
- other: the data on historical control rats were used
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: The animals were observed frequently during the hours following administration of the test substance, for detection of possible treatment-related clinical signs. Thereafter, observation of the animals was made at least once a day. Type, time of onset and duration of clinical signs were recorded for each animal individually.
The animals were weighed individually just before administration of the test substance on day 1 and then on days 8 and 15. The body weight gain of the treated animals was compared to that of test facility's control animals with the same initial body weight.
- Necropsy of survivors performed: yes. After opening the thoracic and abdominal cavities, a macroscopic examination of the main organs (digestive tract, heart, kidneys, liver, lungs, pancreas, spleen and any other organs with obvious abnormalities) was performed. In case of macroscopic lesions, organ samples were taken and preserved in 10% buffered formalin. No microscopic examination was performed.
- Other examinations performed: no - Statistics:
- The LD50 (median lethal dose) is the statistically derived single dose of the test substance that can be expected to cause death in 50% of the animals.
Results and discussion
Effect levels
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Based on:
- test mat.
- Remarks on result:
- other: no signs of toxicity
- Mortality:
- No deaths were observed during the study
- Clinical signs:
- other: No clinical signs were observed during the study
- Gross pathology:
- Macroscopic examination of the main organs of the animals revealed no apparent abnormalities
- Other findings:
- No other findings
Any other information on results incl. tables
Table 1: Individual clinical signs and mortality
Dose (mg/kg) | Time | Animals | Mortality | Clinical signs | |
Males | Females | ||||
2000 | 30 min - 1 h | 01-02-03 | 04-05-06 | No | None |
2h | 01-02-03 | No | None | ||
2h30 | 04-05-06 | No | None | ||
4h00 | 01-02-03 | 04-05-06 | No | None | |
D2toD 15 | 01-02-03 | 04-05-06 | No | None | |
min: minutes h: hour D: day |
Table 2: Individual and mean body weight and weekly body weight change of treated rats (g)
Dose mg/kg | Volume | Animals | Days | |||||
Sex | ||||||||
ml/kg | 1 | (1) | 8 | (1) | 15 | |||
2000 | 10 | Male | 01 | 176 | 79 | 255 | 45 | 300 |
02 | 171 | 71 | 242 | 53 | 295 | |||
03 | 168 | 86 | 254 | 76 | 330 | |||
M | 172 | 79 | 250 | 58 | 308 | |||
SD | 4 | 8 | 7 | 16 | 19 | |||
2000 | 10 | Female | 04 | 141 | 53 | 194 | 31 | 225 |
05 | 136 | 60 | 196 | 23 | 219 | |||
06 | 140 | 45 | 185 | 31 | 216 | |||
M | 139 | 53 | 192 | 28 | 220 | |||
SD | 3 | 8 | 6 | 5 | 5 | |||
(1) = Body weight gain | ||||||||
M = Mean | ||||||||
SD = Standard Deviation |
Table 3: Individual macroscopic examinations at necropsy
Dose mg/kg | Time | Animals | Macroscopic abnormalities | |
Males | Females | |||
2000 | D 15 | 01-02-03 | 04-05-06 | No apparent abnormalities |
D: day |
Applicant's summary and conclusion
- Interpretation of results:
- practically nontoxic
- Remarks:
- Migrated information Criteria used for interpretation of results: EU
- Conclusions:
- Under the experimental conditions of this study, the oral LD5o of the test substance EDDHAS Fe 3K is higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose level.
- Executive summary:
The acute oral toxicity of the test substance Fe3KEDDHSA was evaluated in rats according to the "Acute Toxic Class Method". The study was conducted in compliance with the OECD TG 423. The test substance was prepared in purified water and was administered by oral route (gavage), with a volume of 10 mL/kg, to groups of fasted Sprague-Dawley rats. As the test substance was anticipated to be non-toxic at 2000 mg/kg, a limit test was performed by administering 2000 mg/kg of the test substance to one group of three males. As no deaths occurred, the study was completed by the administration of the dose-level of 2000 mg/kg to one group of three females. Clinical signs, mortality and body weight gain were checked for a period of up to 14 days following the single administration of the test substance. All animals were subjected to necropsy.
No clinical signs and no mortality were observed in the animals given 2000 mg/kg. The overall body weight gain of the animals was not affected by treatment with the test substance. At necropsy, no apparent abnormalities were observed. Under the experimental conditions of this study, the oral LD50 of the test substance EDDHAS Fe 3K is higher than 2000 mg/kg in rats. No signs of toxicity were observed at this dose-level.
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