Registration Dossier
Registration Dossier
Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.
The new ECHA CHEM database has been released by ECHA, and it now contains all REACH registration data. There are more details on the transition of ECHA's published data to ECHA CHEM here.
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EC number: 946-985-9 | CAS number: -
Toxicological Summary
Administrative data
Workers - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.89 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):
- 75
- Dose descriptor starting point:
- NOAEL
- Value:
- 75.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 66.73 mg/m³
- Explanation for the modification of the dose descriptor starting point:
No data avilable for repeated dose toxicity by inhalation route.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was uesd as a starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-chronic study, 28-days
- 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 available for chelates
- AF for remaining uncertainties:
- 1
- Justification:
- no remaning uncertaines
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 1.26 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):
- 300
- Dose descriptor starting point:
- NOAEL
- Value:
- 75.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 378.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
No data avilable for repeated dose toxicity by dermal route.
- AF for dose response relationship:
- 1
- Justification:
- NOAEL used as starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-chronic study, 28-days
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor for other intraspecies differences
- AF for intraspecies differences:
- 5
- Justification:
- standard factor for workers
- 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
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
Workers - Hazard for the eyes
Local effects
- Hazard assessment conclusion:
- no hazard identified
Additional information - workers
Please see attached RA Statement chapter 2.7.4.1 Estimation for NOAEL for systemic effectfor Mg(2Na)IDHA (IUCLID section 13).
General Population - Hazard via inhalation route
Systemic effects
Long term exposure
- Hazard assessment conclusion:
- DNEL (Derived No Effect Level)
- Value:
- 0.22 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):
- 150
- Dose descriptor starting point:
- NOAEL
- Value:
- 75.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEC
- Value:
- 32.91 mg/m³
- AF for dose response relationship:
- 1
- Justification:
- NOAEL was used as a starting point
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-chronic
- AF for interspecies differences (allometric scaling):
- 1
- Justification:
- already taken into account for inhalation exposure
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor
- AF for intraspecies differences:
- 10
- Justification:
- standard factor for general population
- 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
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 0.63 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 75.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 378.5 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
oral studies available
- AF for dose response relationship:
- 1
- Justification:
- oral studies available
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-chronic study
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor
- AF for intraspecies differences:
- 10
- Justification:
- standard factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- several studies available for chelates
- AF for remaining uncertainties:
- 1
- Justification:
- no remining uncertainties
Acute/short term exposure
- Hazard assessment conclusion:
- no hazard identified
DNEL related information
Local effects
Long term exposure
- Hazard assessment conclusion:
- no hazard identified
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:
- 0.13 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):
- 600
- Dose descriptor starting point:
- NOAEL
- Value:
- 75.7 mg/kg bw/day
- Modified dose descriptor starting point:
- NOAEL
- Value:
- 75.7 mg/kg bw/day
- Explanation for the modification of the dose descriptor starting point:
not applicable (oral studies available)
- AF for dose response relationship:
- 1
- Justification:
- oral studies available
- AF for differences in duration of exposure:
- 6
- Justification:
- sub-chronic
- AF for interspecies differences (allometric scaling):
- 4
- Justification:
- rat
- AF for other interspecies differences:
- 2.5
- Justification:
- standard factor
- AF for intraspecies differences:
- 10
- Justification:
- standard factor for general population
- AF for the quality of the whole database:
- 1
- Justification:
- several study 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
Please see attached RA Statement chapter 2.7.4.1 Estimation for NOAEL for systemic effectfor Mg(2Na)IDHA (IUCLID section 13).
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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