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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
25 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:
1 252.85 mg/m³
Explanation for the modification of the dose descriptor starting point:

DNEL for systemic effects via the inhalation route is derived from a rat oral subchronic toxicity study for ammonium sulfate (CAS 7783-20-2)  in which the NOAEL was 256 mg/kg bw/day. Based on the knowledge that 36% of the registered  substance is ammonium sulfate, the equivalent NOAEL for the reaction mass of ammonium iron (III) citrate was calculated to be 711 mg/kg bw. Correction for respiratory rate and volume (rat to human worker): (6.7m3/d/10m3/d)*(1/0.38) (default). Therefore the corrected NOAEC for repeated-dose systemic effects via the inhalation route is [711 mg/m3*(6.7m3/d/10m3/d)*(1/0.38)] = 25 mg/m3

AF for dose response relationship:
1
Justification:
The starting point is the NOAEL above which chronic nephropathy was present.
AF for differences in duration of exposure:
2
Justification:
Default for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not required for inhalation route
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Good quality guideline study
AF for remaining uncertainties:
2
Justification:
Oral to inhalation; higher absorption
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:
7.1 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:
711 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

DNEL for systemic effects via the dermal route is derived from a rat oral subchronic toxicity study for ammonium sulfate (CAS 7783-20-2)  in which the NOAEL was 256 mg/kg bw/day. Based on the knowledge that 36% of the registered  substance is ammonium sulfate, the equivalent NOAEL for the reaction mass of ammonium iron (III) citrate was calculated to be 711 mg/kg bw. Therefore the starting NOAEL for repeated-dose systemic effects via the dermal route is 711 mg/kg bw/day.

AF for dose response relationship:
1
Justification:
The starting point is the NOAEL above which chronic nephropathy was present.
AF for differences in duration of exposure:
2
Justification:
Default for sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default
AF for other interspecies differences:
2.5
Justification:
Default
AF for intraspecies differences:
5
Justification:
Default
AF for the quality of the whole database:
1
Justification:
Good quality guideline study
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

Data from long term studies was available for assessment for both ammonium sulfate (CAS 7783-20-2) and ferric trichloride (CAS 7705-08-0). Based on the known composition of the registered substance, the original NOAELs were used to calculate DNELs expressed as the reaction mass of ammonium iron (III) citrate and ammonium sulfate. As a cautionary approach, the lowest DNELs were then selected and presented as the basis for exposure assessment, which originate from data on ammonium sulfate.

However for completeness, information for ferric trichloride is included as follows:

A 90 day oral study in rat for ferric trichloride was available for assessment which reports a NOAEL of 277 mg/kg bw/day, equivalent to 94.18 mg/kg bw/day expressed as iron. Based on the known composition of the registered substance of 12.2% iron, the NOAEL expressed as the reaction mass of ammonium iron (III) citrate and ammonium sulfate is 771.96 mg/kg bw/day. Based on the same overall assessment factors reported and used for derivation of the current DNELs (based on ammonium sulfate), the respective DNELs derived for ferric trichloride are as follows: 7.7 mg/kg (repeated-dose – systemic – dermal - worker), and 27 mg//m3 (repeated-dose – systemic – inhalation - worker).

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
no hazard identified
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:
no hazard identified
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:
3.6 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:
711 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

DNEL for systemic effects via the oral route is derived from a rat oral subchronic toxicity study for ammonium sulfate (CAS 7783-20-2)  in which the NOAEL was 256 mg/kg bw/day. Based on the knowledge that 36% of the registered  substance is ammonium sulfate, the equivalent NOAEL for the reaction mass of ammonium iron (III) citrate was calculated to be 711 mg/kg bw. Therefore the starting NOAEL for repeated-dose systemic effects via the oral route is 711 mg/kg bw/day.

AF for dose response relationship:
1
Justification:
The starting point is the NOAEL above which chronic nephropathy was present.
AF for differences in duration of exposure:
2
Justification:
Default for subchronic to chronic.
AF for interspecies differences (allometric scaling):
4
Justification:
Default.
AF for other interspecies differences:
2.5
Justification:
Default.
AF for intraspecies differences:
10
Justification:
Default.
AF for the quality of the whole database:
1
Justification:
Good quality guideline study.
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

Data from long term studies was available for assessment for both ammonium sulfate (CAS 7783-20-2) and ferric trichloride (CAS 7705-08-0). Based on the known composition of the registered substance, the original NOAELs were used to calculate DNELs expressed as the reaction mass of ammonium iron (III) citrate and ammonium sulfate. As a cautionary approach, the lowest DNELs were then selected and presented as the basis for exposure assessment, which originate from data on ammonium sulfate.

However for completeness, information for ferric trichloride is included as follows:

A 90 day oral study in rat for ferric trichloride was available for assessment which reports a NOAEL of 277 mg/kg bw/day, equivalent to 94.18 mg/kg bw/day expressed as iron. Based on the known composition of the registered substance of 12.2% iron, the NOAEL expressed as the reaction mass of ammonium iron (III) citrate and ammonium sulfate is 771.96 mg/kg bw/day. Based on the same overall assessment factors reported and used for derivation of the current DNELs (based on ammonium sulfate), the respective DNEL derived for ferric trichloride is: 3.9 mg/kg (repeated-dose – systemic – oral - general population).