Registration Dossier

Diss Factsheets

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
2.917 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:
87.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
The starting point NOEC long-term, inhalation of 87.5 mg/m3/day was calculated from a sub-acute NOAEL long-term, oral of 100 mg/kg bw/day.
AF for dose response relationship:
1
Justification:
Default with NOAEL value as starting point
AF for differences in duration of exposure:
6
Justification:
Extrapolation from sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling factor (rat)
AF for other interspecies differences:
1
Justification:
No indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Good quality data base
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining
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:
0.833 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):
120
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
A NOAEL long-term, dermal of 100 mg/kg bw/day was calculated from a sub-acute NOEL long-term, oral of 100 mg/kg bw/day, assuming 100 % absorption through the skin.
AF for dose response relationship:
1
Justification:
Default with NOAEL value as starting point
AF for differences in duration of exposure:
6
Justification:
Extrapolation from sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling factor (rat)
AF for other interspecies differences:
1
Justification:
No indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
5
Justification:
Default value for workers
AF for the quality of the whole database:
1
Justification:
Good quality data base
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining
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

DNEL derivation for the test item was limited to long-term DNELs, as peak exposures are not expected. Further, only systemic effects were considered, as available data on local effects does not allow derivation of local DNELs.

General Population - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
0.625 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:
37.5 mg/m³
Explanation for the modification of the dose descriptor starting point:
A NOAEC long-term, inhalation of 37.5 mg/m3/day was calculated from a sub-acute NOAEL long-term, oral of 100 mg/kg bw/day (see IUCLID section 7.5.1).
AF for dose response relationship:
1
Justification:
Default with NOAEL value as starting point.
AF for differences in duration of exposure:
6
Justification:
Extrapolation from sub-acute to chronic.
AF for interspecies differences (allometric scaling):
1
Justification:
Not applicable.
AF for other interspecies differences:
1
Justification:
No indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
10
Justification:
Default value for general public.
AF for the quality of the whole database:
1
Justification:
Good quality data base.
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining.
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:
0.417 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):
240
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
A NOAEL long-term, dermal of 100 mg/kg bw/day was calculated from a sub-acute NOAEL long-term, oral of 100 mg/kg bw/day (see IUCLID section 7.5.1).
AF for dose response relationship:
1
Justification:
Default with NOAEL value as starting point
AF for differences in duration of exposure:
6
Justification:
Extrapolation from sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling factor (rat)
AF for other interspecies differences:
1
Justification:
No indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
10
Justification:
Default value for general public.
AF for the quality of the whole database:
1
Justification:
Good quality data base.
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining.
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:
0.417 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):
240
Modified dose descriptor starting point:
NOAEL
Value:
100 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
The NOAEL long-term, oral was 100 mg/kg bw/day, determined in a repeated dose toxicity oral study (see IUCLID section 7.5.1).
AF for dose response relationship:
1
Justification:
Default with NOAEL value as starting point
AF for differences in duration of exposure:
6
Justification:
Extrapolation from sub-acute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Default allometric scaling factor (rat)
AF for other interspecies differences:
1
Justification:
No indication of toxicokinetic or toxicodynamic differences between species.
AF for intraspecies differences:
10
Justification:
Default value for general public.
AF for the quality of the whole database:
1
Justification:
Good quality data base.
AF for remaining uncertainties:
1
Justification:
No uncertainties remaining.
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

DNEL derivation for the test item was limited to long-term DNELs, as peak exposures are not expected. Further, only systemic effects were considered, as available data on local effects does not allow derivation of local DNELs. Instead a quantitative risk assessment was carried out for local effects following potential exposure.