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Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
10 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):
25
Dose descriptor starting point:
LOAEL
Modified dose descriptor starting point:
NOAEC
Value:
83.17 mg/m³
Explanation for the modification of the dose descriptor starting point:

An inhalation DNEL was derived with a route-to route extrapolation, based on the chosen oral NOAEL from other salts.

A LOAEL of 145 mg/kg/day was chosen from the 9 month study

With AF 25, this equates to 5.8 mg/kg/day or 406 mg/day for 70 kg worker; with inhalation rate 10 m3/shift = 40.6 mm/m3

Limit set at 10 mg/m3 for safe working practice

AF for dose response relationship:
1
Justification:
no other uncertainties
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
incorporated in the calculation of the corrected inhalation NOAEC
AF for other interspecies differences:
2.5
Justification:
toxicokinetic/toxicodynamic differences
AF for intraspecies differences:
5
Justification:
DNEL derived for workers
AF for the quality of the whole database:
1
Justification:
the database is complete
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:
2.9 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):
50
Modified dose descriptor starting point:
LOAEL
Value:
145 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

No dermal repeated-dose toxicity study is available. A route-to-route extrapolation from the oral LOAEL oral was chosen for the derivation of the dermal DNEL with a 50% adsorption rate.

The LOAEL for 9 months oral was 145 mg/kg/day = 2.9 mg/kg/day dermal

AF for dose response relationship:
0.5
Justification:
no other uncertainties
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to humans
AF for other interspecies differences:
2.5
Justification:
toxicokinetic/toxicodynamic differences
AF for intraspecies differences:
5
Justification:
DNEL for workers
AF for the quality of the whole database:
1
Justification:
the database is sufficient
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.82 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):
50
Modified dose descriptor starting point:
NOAEC
Value:
83.17 mg/m³
AF for dose response relationship:
1
Justification:
no other uncertainties
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
incorporated in the corrected inhalation NOAEC
AF for other interspecies differences:
2.5
Justification:
toxicokinetic/toxicodynamic differences
AF for intraspecies differences:
10
Justification:
DNEL for the general population
AF for the quality of the whole database:
1
Justification:
the database is sufficient
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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:
0.47 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
Explanation for the modification of the dose descriptor starting point:

No dermal repeated-dose toxicity study is available. A route-to-route extrapolation from the oral NOAEL was chosen for the derivation of the dermal DNEL.

AF for dose response relationship:
1
Justification:
no other uncertainties
AF for differences in duration of exposure:
2.5
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to humans
AF for other interspecies differences:
2
Justification:
toxicokinetic/toxicodynamic differences
AF for intraspecies differences:
10
Justification:
DNEL for general population
AF for the quality of the whole database:
1
Justification:
the data base is sufficient
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Most sensitive endpoint:
skin irritation/corrosion

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.47 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:
94 mg/kg bw/day
AF for dose response relationship:
1
Justification:
no other uncertainties
AF for differences in duration of exposure:
2
Justification:
subchronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
rat to humans
AF for other interspecies differences:
2.5
Justification:
toxicokinetic/toxicodynamic differences
AF for intraspecies differences:
10
Justification:
DNEL for general population
AF for the quality of the whole database:
1
Justification:
the data base is sufficient
Acute/short term exposure
Hazard assessment conclusion:
no hazard identified
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population