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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
Toxicological Summary
- Administrative data
- Workers - Hazard via inhalation route
- Workers - Hazard via dermal route
- Workers - Hazard for the eyes
- Additional information - workers
- General Population - Hazard via inhalation route
- General Population - Hazard via dermal route
- General Population - Hazard via oral route
- General Population - Hazard for the eyes
- Additional information - General Population
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1.8 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 50
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 91 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- the LOAEL was 150 mg/kg bw
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic (3 months) study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- has already been done at the correction in sRV
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences in case of systemic effects
- AF for intraspecies differences:
- 5
- Justification:
- standard assessment factor
- AF for the quality of the whole database:
- 1
- Justification:
- many studies available
- AF for remaining uncertainties:
- 2
- Justification:
- from LOAEL to NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 750 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 200
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 750 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- LOAEL is 150 mg/kg bw
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- workers
- AF for the quality of the whole database:
- 1
- Justification:
- many studies available
- AF for remaining uncertainties:
- 2
- Justification:
- LOAEL to NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - workers
See at justification and comments
Note 1: because EDTA-CuNa2 is hardly absorbed from the gut and is not metabolized no significant differences in toxicokinetics are expected and as such the assessment factor of 2.5 (in case of systemic effects) would not be warranted. However, in view of possible differences in absorption of copper in individuals it was proposed to use this assessment factor.
Note 2: in several European countries the occupational exposure limit for copper (dust) is 1 mg/m3; in some other European countries this limit is 0.2 or 0.1 mg/m3. These limits for copper would correspond to 397.7/63.5 (MW EDTA-CuNa2 / MW Cu) x 1, 0.2 or 0.1, or 6.3, 1.25 or 0.63 mg EDTA-CuNa2/m3, respectively. The calculated DNEL of 1.8 mg/m3 is slightly higher than 0.63 mg/m3 or 1.25 mg/m3 (but lower than 6.3 mg/m3). However, copper-ions are strongly bound by EDTA, they will presumably not be deliberated easily and the unchanged EDTA-copper-complex will be rapidly excreted.
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.45 mg/m³
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 100
- Modified dose descriptor starting point:
- LOAEC
- Value:
- 45 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- LOAEL is 150 mg/kg bw
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic study
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- has already been done at the correction in sRV
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences in case of systemic effects
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- many studies available
- AF for remaining uncertainties:
- 2
- Justification:
- LOAEL to NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 1 875 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 400
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 750 000 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- LOAEL 150 mg/kg bw
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences in case of systemic effects
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- many studies available
- AF for remaining uncertainties:
- 2
- Justification:
- LOAEL to NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.375 mg/kg bw/day
- Most sensitive endpoint:
- repeated dose toxicity
- Route of original study:
- Oral
DNEL related information
- DNEL derivation method:
- ECHA REACH Guidance
- Overall assessment factor (AF):
- 400
- Modified dose descriptor starting point:
- LOAEL
- Value:
- 150 mg/kg bw/day
- AF for dose response relationship:
- 1
- Justification:
- LOAEL 150 mg/kg bw
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- allometric scaling
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences in case of systemic effects
- AF for intraspecies differences:
- 10
- Justification:
- general population
- AF for the quality of the whole database:
- 1
- Justification:
- many studies available
- AF for remaining uncertainties:
- 2
- Justification:
- LOAEL to NOAEL
Acute/short term exposure
- Hazard assessment conclusion:
- low hazard (no threshold derived)
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- low hazard (no threshold derived)
Additional information - General Population
See at justification and comments
Note: because EDTA-CuNa2 is hardly absorbed from the gut and is not metabolized no significant differences in toxicokinetics are expected and as such the assessment factor of 2.5 (in case of systemic effects) would not be warranted. However, in view of possible differences in absorption of copper in individuals it was proposed to use this assessment factor.
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.
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