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:
3.17 mg/m³
Most sensitive endpoint:
effect on fertility
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:
158.68 mg/m³
Explanation for the modification of the dose descriptor starting point:
Only repeat-dose oral data available; inhalation not available.
AF for dose response relationship:
1
Justification:
Not required NOAEC used
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not required for modified dose descriptor used (NOAEC)
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
5
Justification:
Standard default
AF for the quality of the whole database:
2
Justification:
Data based on structural analogue
AF for remaining uncertainties:
1
Justification:
None known
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:
0.9 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
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:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not required absorption from ingestion is considered to be comparable to dermal absorption as a worse case.
AF for dose response relationship:
1
Justification:
Not required as NOAEL used
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Standard default for rat to human
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
5
Justification:
Standard default
AF for the quality of the whole database:
2
Justification:
Based on read across to structural analogue
AF for remaining uncertainties:
1
Justification:
None known
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:
0.78 mg/m³
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
100
Modified dose descriptor starting point:
NOAEC
Value:
78.26
Explanation for the modification of the dose descriptor starting point:
Only long-term oral data available
AF for dose response relationship:
1
Justification:
NOAEC used
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
1
Justification:
Not required for concentrations
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
10
Justification:
Standard default for general population
AF for the quality of the whole database:
2
Justification:
Based on use of read across to structural analogue
AF for remaining uncertainties:
1
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:
0.45 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Modified dose descriptor starting point:
NOAEL
Value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Long-term repeat dose oral data only available.
AF for dose response relationship:
1
Justification:
Not required NOAEL used
AF for differences in duration of exposure:
2
Justification:
sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Standard default for rat to human
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
10
Justification:
Standard default
AF for the quality of the whole database:
2
Justification:
Standard default for use of read across data
AF for remaining uncertainties:
1
Justification:
None known
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:
0.45 mg/kg bw/day
Most sensitive endpoint:
effect on fertility
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
400
Modified dose descriptor starting point:
NOAEL
Value:
180 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
Not required as NOAEL for oral exposure is used
AF for dose response relationship:
1
Justification:
NOAEL used
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
Standard default for rat to human
AF for other interspecies differences:
2.5
Justification:
Standard default
AF for intraspecies differences:
10
Justification:
Standard default for workers
AF for the quality of the whole database:
2
Justification:
Standard default for use of read across data
AF for remaining uncertainties:
1
Justification:
None known
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