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Diss Factsheets
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EC number: 607-234-8 | CAS number: 234446-82-3
- 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
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:
- 12 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):
- 25
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 304 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- oral study available - systemic effects
- AF for dose response relationship:
- 1
- Justification:
- dose-response study available
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already taken into account for inhalation exposure
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- standard factor for workers
- AF for the quality of the whole database:
- 1
- Justification:
- several studies availabel on chelates
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 25 000 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):
- 100
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 2 500 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral study available - systemic effects
- AF for dose response relationship:
- 1
- Justification:
- dose-response study available
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- standard factor
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 5
- Justification:
- standard for worker
- AF for the quality of the whole database:
- 1
- Justification:
- several studies available for chelates
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Definition of the point of departure:
The target compound,Magnesium, EDTA cobalt copper iron manganese zinc complexes, consists of several EDTA-components: EDTA-MnNa2 (30%), EDTA-FeNa (25%), EDTA-CuNa2 (9%), EDTA-ZnNa2 (9%) and EDTA-CoNa2 (<0.5%, i.e. Co2+<0.1%). Other components of the UVCB are water, Na2SO4 and MgSO4. It is not expected that the latter bear a higher hazard than the EDTA-compounds.
There are different studies with EDTA-ingredients of the target substance available for the derivation of a DNEL:
The available data on repeated dose toxicity via the oral route with structurally related source substances showed no adverse effects which are relevant for classification. The NOAEL for EDTA-MnNa2, which is included in the target substance to 30%, is 500 mg/kg bw/d and the NOAEL for EDTA-CuNa2, which is included in the target substance to 9%, is expected to be close to 150 mg/kg bw/d. For the other ingredients EDTA-FeNa (25%) and EDTA-ZnNa (9%) of the target substance the NOEAL is unknown, but it is expected that neither those substances nor its (physiological) iron - or zinc-countercations would not induce higher toxicity compared to the above mentioned substances. This is supported by the results of the repeated dose toxicity study with EDTA-FeNa, where the highest dose tested, 84 mg/kg bw/d, did not induce any adverse effects.
Therefore EDTA-CuNa2 is the ingredient of the target substance showing the lowest effect level, a LOAEL of 150 mg/kg bw/d. Based on the limited effects observed at 150 mg/kg bw/d, the NOAEL would be close to 150 mg/kg bw/d. Therefore an assessment factor of 3 is considered as worst-case assessment factor for LOAEL to NOAEL extrapolation. In addition, to reflect that the quantity of EDTA-CuNa2 in the target compound,Magnesium, EDTA cobalt copper iron manganese zinc complexes,is only 9%, the resulting extrapolated NOAEL is subsequently divided by 0.1 to derive the point of departure for subsequent DNEL derivation.
This results in the following point of departure:
POD=LOAEL/AF 3 (LOAEL to NOAEL)/percentage in target compound to reflect that target compound is a multicomponent substance (UVCB)
POD=150 mg/kg/3/0.1=500 mg/kg bw/d
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 3 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:
- NOAEC
- Value:
- 150 mg/m³
- Explanation for the modification of the dose descriptor starting point:
- oral study available - systemic effects
- AF for dose response relationship:
- 1
- Justification:
- dose-response study available
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- not needed for inhalation exposure
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- standard factor
- AF for the quality of the whole database:
- 1
- Justification:
- several studies available on chelates
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
DNEL related information
Local effects
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard via dermal route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 12 500 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:
- 2 500 000 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- oral route available - systemic effects
- AF for dose response relationship:
- 1
- Justification:
- dose-response study available
- AF for differences in duration of exposure:
- 2
- Justification:
- subchronic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- standard factor
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- standard factor
- AF for the quality of the whole database:
- 1
- Justification:
- several studies available on chelates
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
General Population - Hazard via oral route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 2.5 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:
- 500 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
- not applicable (oral study available)
- AF for dose response relationship:
- 1
- Justification:
- dose response study available
- AF for differences in duration of exposure:
- 2
- Justification:
- subchornic to chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- standard factor
- AF for other interspecies differences:
- 2.5
- Justification:
- remaining differences
- AF for intraspecies differences:
- 10
- Justification:
- standard factor
- AF for the quality of the whole database:
- 1
- Justification:
- several studies on chelates available
- AF for remaining uncertainties:
- 1
- Justification:
- no remaining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
General Population - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - General Population
Definition of the point of departure:
The target compound,Magnesium, EDTA cobalt copper iron manganese zinc complexes, consists of several EDTA-components: EDTA-MnNa2 (30%), EDTA-FeNa (25%), EDTA-CuNa2 (9%), EDTA-ZnNa2 (9%) and EDTA-CoNa2 (<0.5%, i.e. Co2+<0.1%). Other components of the UVCB are water, Na2SO4 and MgSO4. It is not expected that the latter bear a higher hazard than the EDTA-compounds.
There are different studies with EDTA-ingredients of the target substanceavailable for the derivation of a DNEL:
The available data on repeated dose toxicity via the oral route with structurally relatedsource substancesshowed no adverse effects which are relevant for classification. The NOAEL for EDTA-MnNa2, which is included in the target substance to 30%, is 500 mg/kg bw/d and the NOAEL for EDTA-CuNa2, which is included in the target substance to 9%, is expected to be close to 150 mg/kg bw/d. For the other ingredients EDTA-FeNa (25%) and EDTA-ZnNa (9%) of the target substance the NOEAL is unknown, but it is expected that neither those substances nor its (physiological) iron - or zinc-countercations would not induce higher toxicity compared to the above mentioned substances. This is supported by the results of the repeated dose toxicity study with EDTA-FeNa, where the highest dose tested, 84 mg/kg bw/d, did not induce any adverse effects.
Therefore EDTA-CuNa2 isthe ingredient of the target substance showing the lowest effect level, a LOAEL of 150 mg/kg bw/d. Based on the limited effects observed at 150 mg/kg bw/d, the NOAEL would be close to 150 mg/kg bw/d. Therefore an assessment factor of 3 is considered as worst-case assessment factor for LOAEL to NOAEL extrapolation. In addition, to reflect that the quantity of EDTA-CuNa2 in the target compound,Magnesium, EDTA cobalt copper iron manganese zinc complexes,is only 9%, the resulting extrapolated NOAEL is subsequently multiplied by a factor of 10/divided by 0.1 to derive the point of departure for subsequent DNEL derivation.
This results in the following point of departure:
POD=LOAEL/AF 3 (LOAEL to NOAEL)/percentage in target compound to reflect that target compound is a multicomponent substance (UVCB)
POD=150 mg/kg/3/0.1=500 mg/kg bw/d
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.