Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
Value:
3.72 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical Report No. 110
Overall assessment factor (AF):
18
Dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
67 mg/m³
Explanation for the modification of the dose descriptor starting point:

75 mg/kg bw x (1/0.38) x (50% oral absorption/ 100% inhalation absorption) x (6.7/10)

AF for dose response relationship:
1
Justification:
Default value in ECETOC Technical Report No. 110
AF for differences in duration of exposure:
6
Justification:
Extrapolation from subacute study to chronic exposure. Default value in ECETOC Technical Report No. 110
AF for interspecies differences (allometric scaling):
1
Justification:
Already taken into consideration during allometric scaling
AF for other interspecies differences:
1
Justification:
Default valie in ECETOC Technical Report No. 110
AF for intraspecies differences:
3
Justification:
Default value in ECETOC Technical Report No. 110
AF for the quality of the whole database:
1
Justification:
High quality database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
1.04 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 No. 110
Overall assessment factor (AF):
72
Dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Assumed dermal absorption is equal to oral absorption as a precautionary measure

AF for dose response relationship:
1
Justification:
Default value in ECETOC Guidance No. 110
AF for differences in duration of exposure:
6
Justification:
Extrapolation from subacute study to chronic exposure value. Default value in ECETOC Guidance No. 110
AF for interspecies differences (allometric scaling):
4
Justification:
Default value in ECETOC Guidance No. 110
AF for other interspecies differences:
1
Justification:
Default value in ECETOC Guidance No. 110
AF for intraspecies differences:
3
Justification:
Default value in ECETOC Guidance No. 110
AF for the quality of the whole database:
1
Justification:
High quality database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
1.1 mg/m³
Most sensitive endpoint:
repeated dose toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
other: ECETOC Technical Report No. 110
Overall assessment factor (AF):
30
Dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Modified dose descriptor starting point:
NOAEC
Value:
33 mg/m³
Explanation for the modification of the dose descriptor starting point:

75 * 1/1.15 * 0.5

AF for dose response relationship:
1
Justification:
Default value in ECETOC Technical Report No. 110
AF for differences in duration of exposure:
6
Justification:
Extrapolation from subacute study to chronic value. Default value in ECETOC Technical Report No. 110
AF for interspecies differences (allometric scaling):
1
Justification:
Already taken into consideration during allometic scaling
AF for other interspecies differences:
1
Justification:
Default value in ECETOC Technical Report No. 110
AF for intraspecies differences:
5
Justification:
Default value in ECETOC Technical Report No. 110
AF for the quality of the whole database:
1
Justification:
High quality database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
0.625 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 No. 110
Overall assessment factor (AF):
120
Dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
Explanation for the modification of the dose descriptor starting point:

Assumed dermal absorption is equal to oral absorption as a precautionary measure

AF for dose response relationship:
1
Justification:
Default value in ECETOC Technical Report No.110
AF for differences in duration of exposure:
6
Justification:
Extrapolation from subacute to chronic exposure value. Default value in ECETOC Technical Report No. 110
AF for interspecies differences (allometric scaling):
4
Justification:
Default value in ECETOC Technical Report No. 110
AF for other interspecies differences:
1
Justification:
Default value in ECETOC TEchnical Report No. 110
AF for intraspecies differences:
5
Justification:
Default value in ECETOC Technical Report No. 110
AF for the quality of the whole database:
1
Justification:
High quality database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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:
0.625 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
Overall assessment factor (AF):
120
Dose descriptor starting point:
NOAEL
Value:
75 mg/kg bw/day
AF for dose response relationship:
1
Justification:
Default factor in ECETOC Technial Report No. 110
AF for differences in duration of exposure:
6
Justification:
Extrapolation from subacute study to chronic exposure. Default value in ECETOC Technical Report No.110
AF for interspecies differences (allometric scaling):
4
Justification:
Default value in ECETOC Technical Report No.110
AF for other interspecies differences:
1
Justification:
Default value in ECETOC Technical Report No. 110
AF for intraspecies differences:
5
Justification:
Default value in ECETOC Technical Report No. 110
AF for the quality of the whole database:
1
Justification:
High quality database
AF for remaining uncertainties:
1
Justification:
No remaining uncertainties
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