Registration Dossier

Data platform availability banner - registered substances factsheets

Please be aware that this old REACH registration data factsheet is no longer maintained; it remains frozen as of 19th May 2023.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:
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