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EC number: 927-442-5 | CAS number: 15651-72-6
- 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
Endpoint summary
Administrative data
Description of key information
By analogy with FeNaEDTA (CAS 15708-41-5):
- LD50 oral, rat > 2000 mg/kg bw
- LD50 dermal, rat > 2000 mg/kg bw
- LC50 inhalation, rat > 2.75 +/- 0.19 mg/L air
Key value for chemical safety assessment
Acute toxicity: via oral route
Link to relevant study records
- 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:
- July 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well performed study under GLP (as the data is used in a read-across approach, a maximal reliability score of 2 was attributed).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 423 (Acute Oral toxicity - Acute Toxic Class Method)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.1 tris (Acute Oral Toxicity - Acute Toxic Class Method)
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CD/Crl: CD(SD)
- Sex:
- female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Chalrles River, Germany
- Age at study initiation: 7 weeks
- Weight at study initiation: 177-183 g
- Fasting period before study:
- Housing:
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 55 +/-5%
- Air changes (per hr):
- Photoperiod (hrs dark / hrs light): 12/12
IN-LIFE DATES: From: 11 To:26th July 2007 - Route of administration:
- oral: gavage
- Vehicle:
- other: 0.8% aqueous hydroxypropylmethylcellulose
- Details on oral exposure:
- VEHICLE
- Amount of vehicle (if gavage):10 mL/kg bw - Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 6
- Control animals:
- no
- Details on study design:
- no
- Statistics:
- not required
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: No mortalities.
- Mortality:
- no mortalities
- Clinical signs:
- other: no clinical signs
- Gross pathology:
- No pathological changes observed
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- LD50 exceeding the limit dose of 2000 mg/kg bw
- Executive summary:
In an acute oral toxicity study according to OECD guideline 423 a group of female CD rats received a limit dose of 2000 mg/kd bw of FeNaEDTA by gavage administration. No adverse effects were noted, no clinical signs, no mortalities, no effect on body weight and no adverse findings at final necropsy after a 14 days observation period. The LD50 (oral,rat) exceeded 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via inhalation route
Link to relevant study records
- Endpoint:
- acute toxicity: inhalation
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: see 'Remark'
- Remarks:
- Well conducted study according to GLP; one remark: 44% of the particles was smaller than 4 micron, indicating that the MMAD was slightly above 4 micron (1-4 micron is required) (as the data is used in a read-across approach, a maximal reliability score of 2 was attributed).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 403 (Acute Inhalation Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.2 (Acute Toxicity (Inhalation))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CD / Crl: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River, Germany
- Age at study initiation: 51 days(males), 65 days (females)
- Weight at study initiation: 214 - 250 g
- Fasting period before study: 24 h
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-3°C
- Humidity (%): 55 +/-15%
- Photoperiod (hrs dark / hrs light): 12/12 hours - Route of administration:
- inhalation: aerosol
- Type of inhalation exposure:
- nose only
- Vehicle:
- other: water
- Details on inhalation exposure:
- As no dust aerosol could be generated, the test item was dissolved in water to a 5.7% solution the approximate limit of solubility.This solution was used to generate the aerosol of nominal 55.56 mg/L air.
- Analytical verification of test atmosphere concentrations:
- yes
- Duration of exposure:
- 4 h
- Concentrations:
- nominal concentration: 55.56 mg/L air
actual concentraion 2.75 +/- 0.19 mg/L air - No. of animals per sex per dose:
- 5
- Control animals:
- no
- Details on study design:
- - Duration of observation period following administration: 14 days
- Frequency of observations and weighing: weekly
- Necropsy of survivors performed: yes
- Other examinations performed: clinical signs, body weight - Statistics:
- not required
- Sex:
- male/female
- Dose descriptor:
- LC50
- Effect level:
- > 2.75 mg/L air
- Based on:
- test mat.
- Exp. duration:
- 4 h
- Remarks on result:
- other: +/- 0.19, No mortalities.
- Mortality:
- none
- Clinical signs:
- other: none
- Body weight:
- All animals gained the expected body weight.
- Gross pathology:
- No pathological findings
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- LC50 (rat, 4h) exceeded 2.75 +/- 0.19 mg/L the maximum attainable concentration
- Executive summary:
In an acute inhalation toxicity study according to OECD guideline 403 a group of 5 rats per sex was exposed to an aerosol concentration of 2.75 +/-0.19 mg/L air for 4h by the inhalation route. No adverse effects were noted, no clinical signs, no effects on body weight and no adverse findings at final necropsy after a 14 days observation period. It was noted that the MMAD was slight above 4 micron whereas 1 -4 micron is required.
The LC50(rat, inhalation) exceeded 2.75 +/- 0.19 mg/L air.
Reference
nominal concentration |
actual concentration |
mass median aerodynamic diameter |
respirable amount particle size ≤4 µm |
respirable amount particle size ≤4 µm |
[µL/L air] |
[mg/L air] |
[µm] |
[mg/L air] |
[%] |
55.56 |
2.75 |
2.730 |
1.21 |
44.1 |
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Acute toxicity: via dermal route
Link to relevant study records
- Endpoint:
- acute toxicity: dermal
- Type of information:
- migrated information: read-across from supporting substance (structural analogue or surrogate)
- Adequacy of study:
- key study
- Study period:
- July 2007
- Reliability:
- 2 (reliable with restrictions)
- Rationale for reliability incl. deficiencies:
- other: Well conducted study according to GLP (as the data is used in a read-across approach, a maximal reliability score of 2 was attributed).
- Qualifier:
- according to guideline
- Guideline:
- OECD Guideline 402 (Acute Dermal Toxicity)
- Deviations:
- no
- Qualifier:
- according to guideline
- Guideline:
- EU Method B.3 (Acute Toxicity (Dermal))
- Deviations:
- no
- GLP compliance:
- yes (incl. QA statement)
- Test type:
- standard acute method
- Limit test:
- yes
- Species:
- rat
- Strain:
- other: CD / Crl: CD(SD)
- Sex:
- male/female
- Details on test animals or test system and environmental conditions:
- TEST ANIMALS
- Source: Charles River Laboratories, Germanz
- Age at study initiation: 51 days(males), 65 days(femalse)
- Weight at study initiation: 207 - 253 g
- Fasting period before study: 24 h
- Diet (e.g. ad libitum): ad libitum
- Water (e.g. ad libitum):ad libitum
- Acclimation period:5 days
ENVIRONMENTAL CONDITIONS
- Temperature (°C): 22+/-2 °C
- Humidity (%): 55+/-5% r.H.
- Photoperiod (hrs dark / hrs light): 12/12 hours
IN-LIFE DATES: From: 11 To:25 July 2007 - Type of coverage:
- occlusive
- Vehicle:
- water
- Details on dermal exposure:
- TEST SITE
- Area of exposure: 5x6 cm²
- Type of wrap if used: gauze, plastic sheet secured with adhesive
REMOVAL OF TEST SUBSTANCE
- Time after start of exposure:24h
TEST MATERIAL
- Amount(s) applied (volume or weight with unit): 2000 mg/kg bw
- Constant volume or concentration used: yes/no
VEHICLE
- Amount(s) applied (volume or weight with unit):10 mL/kg bw
- Concentration (if solution): 0.2 mg/mL - Duration of exposure:
- 24 h
- Doses:
- 2000 mg/kg bw
- No. of animals per sex per dose:
- 5 males, 5 females
- Control animals:
- no
- Statistics:
- not required
- Sex:
- male/female
- Dose descriptor:
- LD50
- Effect level:
- > 2 000 mg/kg bw
- Remarks on result:
- other: No mortalities.
- Mortality:
- none
- Clinical signs:
- other: none
- Gross pathology:
- no adverse findings
- Interpretation of results:
- study cannot be used for classification
- Remarks:
- Migrated information
- Conclusions:
- LD50 (dermal, rat) exceeds 2000 mg/kg bw
- Executive summary:
In an acute dermal toxicity study according to OECD guideline 402 a group of 5 rats per sex were administered a limit dose of 2000 mg/kg bw by the dermal route for 24h. No adverse effects were noted, no clinical signs, no effects on body weight, no local signs and no adverse findings at final necropsy after a 14 days observation period.
The LD50 (rat, dermal) exceeded 2000 mg/kg bw.
Reference
Endpoint conclusion
- Endpoint conclusion:
- no adverse effect observed
Additional information
There is no data available on EDTAFeHNa but the acute toxicity was assessed by analogy with FeNaEDTA (CAS 15708-41-5).
FeNaEDTA (CAS 15708-41-5) was tested in rats using the three following routes of administration: oral, dermal and inhalation. Each of these key studies should be quoted as reliability 1 according to Klimisch criteria since the studies were performed according to OECD guidelines and in accordance with GLP. However as the data are used in a read-across approach, a maximal reliability score of 2 was attributed to these studies.
Acute toxicity: oral
In an acute oral toxicity study according to OECD guideline 423 a group of female CD rats received a limit dose of 2000 mg/kd bw of FeNaEDTA (CAS 15708-41-5) by gavage administration. No adverse effects were noted, no clinical signs, no mortalities, no effect on body weight and no adverse findings at final necropsy after a 14 days observation period.
The LD50 (oral, rat) exceeded 2000 mg/kg bw.
Acute toxicity: dermal
In an acute dermal toxicity study according to OECD guideline 402 a group of 5 rats per sex were administered a limit dose of 2000 mg/kg bw of FeNaEDTA (CAS 15708-41-5) by the dermal route for 24h. No adverse effects were noted, no clinical signs, no effects on body weight, no local signs and no adverse findings at final necropsy after a 14 days observation period.
The LD50 (rat, dermal) exceeded 2000 mg/kg bw.
Acute toxicity: inhalation
In an acute inhalation toxicity study according to OECD guideline 403 a group of 5 rats per sex was exposed to an aerosol concentration of 2.75 +/- 0.19 mg/L air to FeNaEDTA (CAS 15708-41-5) for 4h by the inhalation route. No adverse effects were noted, no clinical signs, no effects on body weight and no adverse findings at final necropsy after a 14 days observation period. It was noted that the MMAD was slight above 4 micron whereas 1 -4 micron is required.
The LC50 (rat, inhalation) exceeded 2.75 ± 0.19 mg/L air.
Justification for selection of acute toxicity – oral endpoint
Well conducted study according to GLP
Justification for selection of acute toxicity – inhalation endpoint
Well conducted study according to GLP
Justification for selection of acute toxicity – dermal endpoint
Well conducted study according to GLP
Justification for classification or non-classification
Based on data on the analogous substanceFeNaEDTA (CAS 15708-41-5) which induced no mortality in the rat following a single exposure by oral or dermal route up to a limit dose/concentration of 2000 mg/kg bw and by inhalation up to 2.75 mg/L air, EDTAFeHNa should not be classified for acute toxicity via the oral, dermal or inhalation route as defined by the criteria of Annex VI Directive 67/548/EEC or UN/EU GHS classification criteria.
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