Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
13.8 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
By inhalation
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
75
Dose descriptor starting point:
NOAEC
Value:
2 060 mg/m³
Modified dose descriptor starting point:
NOAEC
Value:
1 035 mg/m³
Explanation for the modification of the dose descriptor starting point:

The DNEL is derived from the NOAEC higher than 2060 mg/m3 from the 28-day inhalation toxicity study (Pothmann, 2014) after correction for difference in exposure conditions and between respiratory rates under standard conditions and under conditions of light activity ( x 6h/8h x 6.7 m3/10 m3).

AF for dose response relationship:
1
Justification:
not needed
AF for differences in duration of exposure:
6
Justification:
DNEL based on an inhalation 28 day study
AF for interspecies differences (allometric scaling):
1
Justification:
AF not used for inhalation route
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
5
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not needed
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:
4.7 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 400 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Considering the physico-chemical properties, the dermal absorption is expected to be low and whatever not higher than the absorption by the oral or inhalation routes.

AF for dose response relationship:
1
Justification:
not needed
AF for differences in duration of exposure:
6
Justification:
DNEL based on a subacute exposure toxicity study
AF for interspecies differences (allometric scaling):
4
Justification:
default AF
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
5
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not needed
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:
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:
1.7 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:
1 000 mg/kg bw/day
Modified dose descriptor starting point:
NOAEL
Value:
1 000 mg/kg bw/day
AF for dose response relationship:
1
Justification:
not needed
AF for differences in duration of exposure:
6
Justification:
default AF
AF for interspecies differences (allometric scaling):
4
Justification:
default AF
AF for other interspecies differences:
2.5
Justification:
default AF
AF for intraspecies differences:
10
Justification:
default AF
AF for the quality of the whole database:
1
Justification:
not needed
AF for remaining uncertainties:
1
Justification:
not 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