Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
7 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):
300
Modified dose descriptor starting point:
NOAEC
Value:
2 100 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation study available
AF for dose response relationship:
1
Justification:
REACH Guidance Table R.8-6
AF for differences in duration of exposure:
6
Justification:
REACH Guidance Table R.8-6-subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
REACH Guidance Table R.8-6-rat
AF for other interspecies differences:
2.5
Justification:
REACH Guidance Table R.8-6
AF for intraspecies differences:
5
Justification:
REACH Guidance Table R.8-6
AF for the quality of the whole database:
1
Justification:
REACH Guidance Table R.8-6v
AF for remaining uncertainties:
1
Justification:
REACH Guidance Table R.8-6
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:
1 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
Modified dose descriptor starting point:
NOAEL
Value:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal study available
AF for dose response relationship:
1
Justification:
REACH Guidance Table R.8-6
AF for differences in duration of exposure:
6
Justification:
REACH Guidance Table R.8-6-subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
REACH Guidance Table R.8-6-rat
AF for other interspecies differences:
2.5
Justification:
REACH Guidance Table R.8-6
AF for intraspecies differences:
5
Justification:
REACH Guidance Table R.8-6
AF for the quality of the whole database:
1
Justification:
REACH Guidance Table R.8-6
AF for remaining uncertainties:
1
Justification:
REACH Guidance Table R.8-6
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:
3.5 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):
600
Modified dose descriptor starting point:
NOAEC
Value:
2 100 mg/m³
Explanation for the modification of the dose descriptor starting point:
No inhalation study available
AF for dose response relationship:
1
Justification:
REACH Guidance Table R.8-6
AF for differences in duration of exposure:
6
Justification:
REACH Guidance Table R.8-6-subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
REACH Guidance Table R.8-6-rat
AF for other interspecies differences:
2.5
Justification:
REACH Guidance Table R.8-6
AF for intraspecies differences:
10
Justification:
REACH Guidance Table R.8-6
AF for the quality of the whole database:
1
Justification:
REACH Guidance Table R.8-6
AF for remaining uncertainties:
1
Justification:
REACH Guidance Table R.8-6
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:
0.5 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:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
No dermal study available
AF for dose response relationship:
1
Justification:
REACH Guidance Table R.8-6
AF for differences in duration of exposure:
6
Justification:
REACH Guidance Table R.8-6-subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
REACH Guidance Table R.8-6-rat
AF for other interspecies differences:
2.5
Justification:
REACH Guidance Table R.8-6
AF for intraspecies differences:
10
Justification:
REACH Guidance Table R.8-6
AF for the quality of the whole database:
1
Justification:
REACH Guidance Table R.8-6
AF for remaining uncertainties:
1
Justification:
REACH Guidance Table R.8-6
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:
0.5 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:
300 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:
/
AF for dose response relationship:
1
Justification:
REACH Guidance Table R.8-6
AF for differences in duration of exposure:
6
Justification:
REACH Guidance Table R.8-6-subacute to chronic
AF for interspecies differences (allometric scaling):
4
Justification:
REACH Guidance Table R.8-6-rat
AF for other interspecies differences:
2.5
Justification:
REACH Guidance Table R.8-6
AF for intraspecies differences:
10
Justification:
REACH Guidance Table R.8-6
AF for the quality of the whole database:
1
Justification:
REACH Guidance Table R.8-6
AF for remaining uncertainties:
1
Justification:
REACH Guidance Table R.8-6
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