Registration Dossier

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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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.

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
21.1 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
Dose descriptor starting point:
NOAEL
Value:
427.35 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
1 054.88 mg/m³
Explanation for the modification of the dose descriptor starting point:

A NOAEL of 427.35 mg/kg bw /day from a sub-chronic repeated dose oral toxicity study with the read-across substance iron gluconate is available for rats (Berenbaum, 1960). This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/0.38 m3/kg/d, the absorption rates (oral 100 %, inhalation 100 %), the standard respiratory volume in humans/ worker respiratory volume (6.7 m3 (8 h) / 10 m3 (8 h)) and a correction factor of 1.4 for human and experimental exposure conditions (5 working days vs. 7 days continuous exposure).

NOAEC corrected = 427.35 mg/kg bw/day * 1/0.38 m³/kg/d * 100/100 * (6.7 m³/10 m³) * 1.4= 1054.88 mg/m³

AF for dose response relationship:
1
Justification:
default (three doses were tested, using a spacing range of 2 fold)
AF for differences in duration of exposure:
2
Justification:
sub-chronic (90 d) to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling should be applied in case of oral-to-inhalation extrapolation
AF for other interspecies differences:
2.5
Justification:
default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
2
Justification:
read-across, no guideline followed
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

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
29.91 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
Dose descriptor starting point:
NOAEL
Value:
427.35 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
5 982.9 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A NOAEL of 427.35 mg/kg bw /day from the repeated dose oral toxicity study with the read-across substance iron gluconate is available for rats (Berenbaum, 1960). This value was converted into the corrected dermal NOAEL taking into account the absorption rates for absorption (oral 100 %, dermal 10 %) (please refer to the toxicokinetic endpoint) and a correction factor of 1.4 for human and experimental exposure conditions (5 working days vs. 7 days continuous exposure).

NOAEL corrected = 427.35 mg/kg bw/day x 1/0.1 x 1.4 = 5982.9 mg/kg bw/day

AF for dose response relationship:
1
Justification:
default (three doses were tested, using a spacing range of 2 fold)
AF for differences in duration of exposure:
2
Justification:
sub-chronic (90 d) to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling (rat to human)
AF for other interspecies differences:
2.5
Justification:
default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
AF for intraspecies differences:
5
Justification:
default for workers
AF for the quality of the whole database:
2
Justification:
read-across, no guideline followed
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

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.17 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
Dose descriptor starting point:
NOAEL
Value:
427.35 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
316.56 mg/m³
Explanation for the modification of the dose descriptor starting point:

A NOAEL of 427.35 mg/kg bw /day from the repeated dose oral toxicity study with the read-across substance iron gluconate is available for rats (Berenbaum, 1960). This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/1.35 m3/kg/d (for 60 kg humans) and the absorption rates (oral 100 %, inhalation 100 %).

NOAEC corrected = 427.35 mg/kg bw/day * 1/1.35 m³/kg/day * 100/100 = 316.56 mg/m³

AF for dose response relationship:
1
Justification:
default (three doses were tested, using a spacing range of 2 fold)
AF for differences in duration of exposure:
2
Justification:
sub-chronic (90 d) to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
No allometric scaling should be applied in case of oral-to-inhalation extrapolation
AF for other interspecies differences:
2.5
Justification:
default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
AF for intraspecies differences:
10
Justification:
default for general population
AF for the quality of the whole database:
2
Justification:
read-across, no guideline followed
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:
10.68 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
Dose descriptor starting point:
NOAEL
Value:
427.35 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
4 273.5 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A NOAEL of 427.35 mg/kg bw /day from a repeated dose oral toxicity study with the read-across substance iron gluconate is available for rats (Berenbaum, 1960). This value was converted into the corrected dermal NOAEL taking into account the absorption rates (oral 100 %, dermal 10 %) (please refer to the toxicokinetic endpoint).

NOAEL corrected = 427.35 mg/kg bw/day x 1/0.1 = 4273.5 mg/kg bw/day

AF for dose response relationship:
1
Justification:
default (three doses were tested, using a spacing range of 2 fold)
AF for differences in duration of exposure:
2
Justification:
sub-chronic (90 d) to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
allometric scaling (rat to human)
AF for other interspecies differences:
2.5
Justification:
default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
AF for intraspecies differences:
10
Justification:
default for general population
AF for the quality of the whole database:
2
Justification:
read-across, no guideline followed
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

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.07 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
Dose descriptor starting point:
NOAEL
Value:
427.35 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
427.35 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

not relevant, no route-to-route extrapolation needed

AF for dose response relationship:
1
Justification:
default (three doses were tested, using a spacing range of 2 fold)
AF for differences in duration of exposure:
2
Justification:
since it is a subchronic study
AF for interspecies differences (allometric scaling):
4
Justification:
default for rats
AF for other interspecies differences:
2.5
Justification:
default; no substance and route specific information on toxicokinetic and toxicodynamic is available for animals and humans
AF for intraspecies differences:
10
Justification:
default for general population
AF for the quality of the whole database:
2
Justification:
read-across, no guideline followed
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties are identified
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