Registration Dossier

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).