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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
16.74 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:
339 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
836.79 mg/m³
Explanation for the modification of the dose descriptor starting point:

A NOAEL of 339 mg/kg bw /day was derived by quantitative read-across from the source substance zinc sulfate. Zinc sulfate was tested in a sub-chronic repeated dose oral toxicity study in rats (Maita et al. 1981). This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of 1/0.38 m3/kg/day, 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 the correction factor between human and experimental exposure conditions workers (5 working days vs. 7 days continuous exposure) of 1.4.

NOAEC corrected = 339 mg/kg bw/day * 1/0.38 m³/kg/day * 100/100 * (6.7 m³/10 m³) * 1.4 = 836.79 mg/m³

AF for dose response relationship:
1
Justification:
default (three doses were tested, using a spacing range of 10 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:
23.73 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:
339 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
4 746 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A NOAEL of 339 mg/kg bw /day was derived by quantitative read-across from the source substance zinc sulfate. Zinc sulfate was tested in a sub-chronic repeated dose oral toxicity study in rats (Maita et al. 1981).

The dose descriptor starting point is obtained by conversion of the oral NOAEL of 339 mg/kg bw to a dermal NOAEL taking into account an oral absorption of 100% and a dermal absorption of 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 = 339 mg/kg bw/day * 1/0.1 * 1.4 = 4746 mg/kg bw/day

AF for dose response relationship:
1
Justification:
default (three doses were tested, using a spacing range of 10 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:
2.51 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:
339 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
251.11 mg/m³
Explanation for the modification of the dose descriptor starting point:

A NOAEL of 339 mg/kg bw /day was derived by quantitative read-across from the source substance zinc sulfate. Zinc sulfate was tested in a sub-chronic repeated dose oral toxicity study in rats (Maita et al. 1981). This value was converted into the corrected inhalatory NOAEC taking into account the standard respiratory factor of sRV (standard respiratory volume of rats during 24 hours) of 1.35 m3/kg/day (human of 60 kg) and the absorption rate (oral 100 %, inhalation 100 %).

NOAEC corrected = 339 mg/kg bw/day * 1/1.35 m³/kg/day * 100/100 = 251.11 mg/m³

AF for dose response relationship:
1
Justification:
default (three doses were tested, using a spacing range of 10 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:
8.48 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:
339 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
3 390 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

A NOAEL of 339 mg/kg bw /day was derived by quantitative read-across from the source substance zinc sulfate. Zinc sulfate was tested in a sub-chronic repeated dose oral toxicity study in rats (Maita et al. 1981). This value was converted into a dermal NOAEL taking into account an oral absorption of 100% and a dermal absorption of 10 % (please refer to the toxicokinetic endpoint).

NOAEL corrected = 339 mg/kg bw/day * 1/0.1 = 3390 mg/kg bw/day

AF for dose response relationship:
1
Justification:
default (three doses were tested, using a spacing range of 10 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:
0.85 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:
339 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
339 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

not relevant, no route-to-route extrapolation required

AF for dose response relationship:
1
Justification:
default (three doses were tested, using a spacing range of 10 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

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population