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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
8.82 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:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
661.18 mg/m³
Explanation for the modification of the dose descriptor starting point:

Key oral combined repeated dose toxicity/reproductive and developmental toxicity study available; no repeated dose inhalation toxicity study available. In absence of kinetic data, inhalation absorption is considered 2x oral absorption as conservative approach.

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
6
Justification:
ECHA default (subacute study)
AF for interspecies differences (allometric scaling):
1
Justification:
Factor already taken into account in route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Based on high reliability study
AF for remaining uncertainties:
1
Justification:
No indication that another factor is needed
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.5 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:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Key oral combined repeated dose toxicity/reproductive and developmental toxicity study available; no

repeated dose inhalation toxicity study available. In absence of kinetic data, inhalation absorption is

considered 2x oral absorption as conservative approach

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
6
Justification:
ECHA default (subacute study)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
5
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Based on high reliability study
AF for remaining uncertainties:
1
Justification:
No indication that another factor is needed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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

Source information for the DNELs:

A key combined repeated dose/reproductive & developmental toxicity study for subacute oral toxicity in rats

was available for read across substance iron dichloride, showing NOAEL values of 125 and 250 mg/kg bw

for males and females, respectively. Identified target organs were the liver, stomach and adrenal gland.

Read across with iron dichloride is justified, although a factor 6 was considered in benefit of iron sulfide,

which would bring the NOAEL to 750 mg/kg bw. The relevance of the stomach as target organ for iron sulfide

is questioned, as it has no corrosive proporties. A 90-day study was waived based on the availability of a

carcinogenicity study. A key 24-month carcinogenicity study was available in rats for ferric chloride by drink

water administration at concentrations of 0.25 and 0.5%, corresponding with mean dose levels of 170 and

320 mg/kg bw in males and 188 and 336 mg/kg bw in females. NOAEL for systemic toxicity was 170/188 mg/kg

in males/females, whereas NOAEL for carcinogenicity was 320/336 mg/kg bw in males/females.For iron sulfide,

similar NOAEL values are assumed.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.17 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):
150
Dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
326.09 mg/m³
Explanation for the modification of the dose descriptor starting point:

Key oral combined repeated dose toxicity/reproductive and developmental toxicity study available; no

repeated dose inhalation toxicity study available. In absence of kinetic data, inhalation absorption is

considered 2x oral absorption as conservative approach.

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
6
Justification:
ECHA default (subacute study)
AF for interspecies differences (allometric scaling):
1
Justification:
Factor already taken into account in route to route extrapolation
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Based on high reliability study
AF for remaining uncertainties:
1
Justification:
No indication that another factor is needed
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.25 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:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Key 28-day oral toxicity study available; no repeated dose dermal toxicity study available. In absence of

kinetic data, dermal absorption is considered equal to oral absorption as conservative approach.

AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
6
Justification:
ECHA default (subacute study)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Based on high reliability study
AF for remaining uncertainties:
1
Justification:
No indication that another factor is needed
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
hazard unknown but no further hazard information necessary as no exposure expected
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:
1.25 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:
750 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
750 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not applicable
AF for dose response relationship:
1
Justification:
ECHA default
AF for differences in duration of exposure:
6
Justification:
ECHA default (subacute study)
AF for interspecies differences (allometric scaling):
4
Justification:
ECHA default
AF for other interspecies differences:
2.5
Justification:
ECHA default
AF for intraspecies differences:
10
Justification:
ECHA default
AF for the quality of the whole database:
1
Justification:
Based on high reliability study
AF for remaining uncertainties:
1
Justification:
No indication that another factor is needed
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

Source information for the DNELs:

A key combined repeated dose/reproductive & developmental toxicity study for subacute oral toxicity in rats

was available for read across substance iron dichloride, showing NOAEL values of 125 and 250 mg/kg bw

for males and females, respectively. Identified target organs were the liver, stomach and adrenal gland.

Read across with iron dichloride is justified, although a factor 6 was considered in benefit of iron sulfide,

which would bring the NOAEL to 750 mg/kg bw. The relevance of the stomach as target organ for iron

sulfide is questioned, as it has no corrosive proporties. A 90-day study was waived based on the availability

of a carcinogenicity study. A key 24-month carcinogenicity study was available in rats for ferric chloride by

drink water administration at concentrations of 0.25 and 0.5%, corresponding with mean dose levels of

170 and 320 mg/kg bw in males and 188 and 336 mg/kg bw in females. NOAEL for systemic toxicity was

170/188 mg/kg in males/females, whereas NOAEL for carcinogenicity was 320/336 mg/kg bw in

males/females. For iron sulfide, similar NOAEL values are assumed.