Registration Dossier
Registration Dossier
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EC number: 268-018-3 | CAS number: 67989-88-2
Toxicological Summary
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
- Explanation for the modification of the dose descriptor starting point:
Systemic effects
- 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:
- low hazard (no threshold derived)
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:
- no hazard identified
Additional information - workers
See at justification and comments
Note 1: because EDTA-Cu(NH4)2 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 387.8/63.5 (MW EDTA-Cu(NH4)2 / MW Cu) x 1, 0.2 or 0.1, or 6.1, 1.22 or 0.61 mg EDTA-Cu(NH4)2/m3, respectively. The calculated DNEL of 1.8 mg/m3 is slightly higher than 0.61 mg/m3 or 1.22 mg/m3 (but lower than 6.1 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
- Explanation for the modification of the dose descriptor starting point:
systemic effects
- 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:
- no hazard identified
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:
- low hazard (no threshold derived)
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
- Explanation for the modification of the dose descriptor starting point:
systemic effects
- 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:
- no hazard identified
Additional information - General Population
See at justification and comments
Note: because EDTA-Cu(NH4)2 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.
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