Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
1.47 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):
60
Modified dose descriptor starting point:
NOAEC
Value:
88.16 mg/m³
Explanation for the modification of the dose descriptor starting point:
Available data do not suggest a pronounced difference between oral and inhalation route. Due to a lack of experimental data the NOAEC (corr) was derived including ECHAs recommended absorption rates for exposure via the oral (50%) and inhalation (100%) route.
AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
6
Justification:
extrapolation from sub-acute to chronic (default)
AF for interspecies differences (allometric scaling):
1
Justification:
default (inhalation)
AF for other interspecies differences:
2
Justification:
default
AF for intraspecies differences:
5
Justification:
default (worker)
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
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)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

Workers - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - workers

The hazard assessment is mainly based on the corrosive properties of the substance. Systemic hazard by the dermal route has not been assessed as local effects are considered more relevant to determine the appropriate risk management measures.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.36 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):
120
Modified dose descriptor starting point:
NOAEC
Value:
43.48 mg/m³
Explanation for the modification of the dose descriptor starting point:
Available data do not suggest a pronounced difference between oral and inhalation route. Due to a lack of experimental data the NOAEC (corr) was derived including ECHAs recommended absorption rates for exposure via the oral (50%) and inhalation (100%) route.
AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
6
Justification:
extrapolation from sub-acute to chronic (default)
AF for interspecies differences (allometric scaling):
1
Justification:
default (inhalation)
AF for other interspecies differences:
2
Justification:
default
AF for intraspecies differences:
10
Justification:
default (general population)
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
no remaining uncertainties identified
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

Local effects

Long term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)
Acute/short term exposure
Hazard assessment conclusion:
medium hazard (no threshold derived)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.17 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
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
AF for dose response relationship:
1
Justification:
default
AF for differences in duration of exposure:
6
Justification:
extrapolation from sub-acute to chronic (default)
AF for interspecies differences (allometric scaling):
4
Justification:
default (rat)
AF for other interspecies differences:
2.5
Justification:
default
AF for intraspecies differences:
10
Justification:
default (general population)
AF for the quality of the whole database:
1
Justification:
default
AF for remaining uncertainties:
1
Justification:
default
Acute/short term exposure
Hazard assessment conclusion:
hazard unknown (no further information necessary)
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
medium hazard (no threshold derived)

Additional information - General Population

The hazard assessment is mainly based on the corrosive properties of the substance. Systemic hazard by the dermal route has not been assessed as local effects are considered more relevant to determine the appropriate risk management measures.