Registration Dossier

Administrative data

Workers - Hazard via inhalation route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
9.45 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
375
Modified dose descriptor starting point:
NOAEC
3 545.5 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
30
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

Workers - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
1.35 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
1 500
Modified dose descriptor starting point:
NOAEL
2 026 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
30
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
5
AF for the quality of the whole database:
1
Acute/short term exposure
DNEL related information

Local effects

Long term exposure
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Most sensitive endpoint:
sensitisation (skin)

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)
2.36 mg/m³
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
750
Modified dose descriptor starting point:
NOAEC
1 772.75 mg/m³
AF for dose response relationship:
1
AF for differences in duration of exposure:
30
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
Acute/short term exposure
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Most sensitive endpoint:
sensitisation (skin)
DNEL related information

General Population - Hazard via dermal route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
0.67 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3 000
Modified dose descriptor starting point:
NOAEL
AF for dose response relationship:
1
AF for differences in duration of exposure:
30
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
Acute/short term exposure
Most sensitive endpoint:
acute toxicity
DNEL related information

Local effects

Long term exposure
Most sensitive endpoint:
sensitisation (skin)
Acute/short term exposure
Most sensitive endpoint:
sensitisation (skin)

General Population - Hazard via oral route

Systemic effects

Long term exposure
Hazard assessment conclusion:
DNEL (Derived No Effect Level)
0.67 mg/kg bw/day
Most sensitive endpoint:
acute toxicity
Route of original study:
Oral
DNEL related information
DNEL derivation method:
ECHA REACH Guidance
Overall assessment factor (AF):
3 000
Modified dose descriptor starting point:
NOAEL
2 026 mg/kg bw/day
AF for dose response relationship:
1
AF for differences in duration of exposure:
30
AF for interspecies differences (allometric scaling):
4
AF for other interspecies differences:
2.5
AF for intraspecies differences:
10
AF for the quality of the whole database:
1
Acute/short term exposure
Most sensitive endpoint:
acute toxicity
DNEL related information

General Population - Hazard for the eyes

Local effects

Hazard assessment conclusion:
no hazard identified

Additional information - General Population