Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
22.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical Report N°86 and 110
Overall assessment factor (AF):
24
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
PoD NOAEL
AF for differences in duration of exposure:
2
Justification:
Subchronic to chronic exposure duration
AF for other interspecies differences:
4
Justification:
Rat to human
AF for intraspecies differences:
3
Justification:
Worker
AF for the quality of the whole database:
1
Justification:
experimental study (guideline study)
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:
12.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical report n°86 & 110
Overall assessment factor (AF):
24
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
Justification:
PoD: NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic exposure duration
AF for other interspecies differences:
4
Justification:
Rat to human
AF for intraspecies differences:
3
Justification:
Worker
AF for the quality of the whole database:
1
Justification:
experimental study (guideline study)
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:
6.52 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical report n°86 & 110
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEC
AF for dose response relationship:
1
Justification:
PoD: NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic exposure duration
AF for other interspecies differences:
4
Justification:
Rat to human
AF for intraspecies differences:
5
Justification:
General Population
AF for the quality of the whole database:
1
Justification:
experimental study (guideline study)
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:
7.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical report n°86 & 110
Overall assessment factor (AF):
40
Modified dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
Justification:
PoD: NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic exposure duration
AF for other interspecies differences:
4
Justification:
Rat to human
AF for intraspecies differences:
5
Justification:
General Population
AF for the quality of the whole database:
1
Justification:
experimental study (guideline study)
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:
7.5 mg/kg bw/day
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical report n°86 & 110
Overall assessment factor (AF):
40
Dose descriptor starting point:
NOAEL
Modified dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
Justification:
PoD: NOAEL
AF for differences in duration of exposure:
2
Justification:
Sub-chronic to chronic exposure duration
AF for other interspecies differences:
4
Justification:
Rat to human
AF for intraspecies differences:
5
Justification:
General Population
AF for the quality of the whole database:
1
Justification:
experimental study (guideline study)
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